Trial Outcomes & Findings for A Study of the Patterns of Use of Etoricoxib in France (MK-0663-148) (NCT NCT01572675)
NCT ID: NCT01572675
Last Updated: 2022-02-09
Results Overview
Proper use of study medication is defined as administration of medication in terms of indication and dosage according to Market Authorization (MA). Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.
Recruitment status
COMPLETED
Target enrollment
547 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2022-02-09
Participant Flow
621 total participants were screened; 71 participants were excluded for inclusion criteria violation and 3 were excluded for unavailability of informed consent.
Participant milestones
| Measure |
Group Arcoxia®
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|
|
Overall Study
STARTED
|
268
|
279
|
|
Overall Study
COMPLETED
|
31
|
56
|
|
Overall Study
NOT COMPLETED
|
237
|
223
|
Reasons for withdrawal
| Measure |
Group Arcoxia®
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|
|
Overall Study
End of prescribed treatment
|
140
|
118
|
|
Overall Study
Recovery
|
16
|
23
|
|
Overall Study
Lack of Efficacy
|
31
|
31
|
|
Overall Study
Intolerance
|
6
|
5
|
|
Overall Study
Improved symptoms
|
8
|
2
|
|
Overall Study
Surgical intervention
|
3
|
6
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Death unrelated to coxibs
|
1
|
1
|
|
Overall Study
Other disease detected
|
1
|
1
|
|
Overall Study
Unknown reason
|
1
|
1
|
|
Overall Study
Rheumatologist new evaluation
|
0
|
1
|
|
Overall Study
Missing data
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
22
|
27
|
Baseline Characteristics
A Study of the Patterns of Use of Etoricoxib in France (MK-0663-148)
Baseline characteristics by cohort
| Measure |
Group Arcoxia®
n=268 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=279 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Total
n=547 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.8 Years
STANDARD_DEVIATION 13.8 • n=93 Participants
|
62.4 Years
STANDARD_DEVIATION 14.2 • n=4 Participants
|
61.6 Years
STANDARD_DEVIATION 14.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
166 Participants
n=93 Participants
|
179 Participants
n=4 Participants
|
345 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=93 Participants
|
100 Participants
n=4 Participants
|
202 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: All participants with complete data relative to correct use of the coxib and at least 1 data point relative to misuse of the coxib.
Proper use of study medication is defined as administration of medication in terms of indication and dosage according to Market Authorization (MA). Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.
Outcome measures
| Measure |
Group Arcoxia®
n=257 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=264 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Number of Participants Demonstrating Proper Use of Arcoxia® and Celebrex®
|
65 Participants
|
118 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (misuse)
Proper use of study medication is defined as administration of medication in terms of indication and dosage according to MA. Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.
Outcome measures
| Measure |
Group Arcoxia®
n=192 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=146 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Reasons for Misuse of Arcoxia® and Celebrex®
Non-MA-Compliant Indication
|
83 Participants
|
114 Participants
|
—
|
—
|
—
|
—
|
|
Reasons for Misuse of Arcoxia® and Celebrex®
Non-MA-Compliant Starting Dose
|
62 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Reasons for Misuse of Arcoxia® and Celebrex®
Non-MA-Compliant Starting Dose and Indication
|
46 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Reasons for Misuse of Arcoxia® and Celebrex®
Non-MA-Compliant Indication & Dose (Starting &Max)
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At study entryPopulation: The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (indication)
The reasons (indications) for prescribing of Arcoxia® or Celebrex® were collected in open-field forms by the Investigator; category assignment (i.e, re-codification) of verbatim entries was conducted by a group of medical experts under the guidance approved by the MA. This endpoint gives the number of participants treated per indication.
Outcome measures
| Measure |
Group Arcoxia®
n=264 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=275 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Indications for Which Arcoxia® and Celebrex® Were Prescribed
Other pain (e.g., spinal pain, joint pain)
|
113 Participants
|
117 Participants
|
—
|
—
|
—
|
—
|
|
Indications for Which Arcoxia® and Celebrex® Were Prescribed
Osteoarthritis
|
105 Participants
|
104 Participants
|
—
|
—
|
—
|
—
|
|
Indications for Which Arcoxia® and Celebrex® Were Prescribed
Inflammatory rheumatism
|
13 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Indications for Which Arcoxia® and Celebrex® Were Prescribed
Neuralgia
|
17 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
|
Indications for Which Arcoxia® and Celebrex® Were Prescribed
Non-joint rheumatism
|
12 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Indications for Which Arcoxia® and Celebrex® Were Prescribed
Unclassified arthropathy
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Indications for Which Arcoxia® and Celebrex® Were Prescribed
Missing data
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At study entryPopulation: The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (dosage at initiation)
Dosage at initiation of treatment with Arcoxia® or Celebrex® was identified. MA compliant dosage at initiation corresponds to a (starting) dose of 30 mg daily for Arcoxia® or a (starting) dose of 200 mg daily for Celebrex®. The dose for initiation was calculated by multiplying the number of doses per day with the dose level (total daily dose) as noted in the prescription record.
Outcome measures
| Measure |
Group Arcoxia®
n=268 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=279 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Dosage of Arcoxia® and Celebrex® at Initiation
30 mg
|
151 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Dosage of Arcoxia® and Celebrex® at Initiation
60 mg
|
107 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Dosage of Arcoxia® and Celebrex® at Initiation
> 60 mg; <100 mg
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Dosage of Arcoxia® and Celebrex® at Initiation
100 mg
|
0 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
|
Dosage of Arcoxia® and Celebrex® at Initiation
>100 mg; < 200 mg
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Dosage of Arcoxia® and Celebrex® at Initiation
200 mg
|
0 Participants
|
219 Participants
|
—
|
—
|
—
|
—
|
|
Dosage of Arcoxia® and Celebrex® at Initiation
400 mg
|
0 Participants
|
32 Participants
|
—
|
—
|
—
|
—
|
|
Dosage of Arcoxia® and Celebrex® at Initiation
> 400 mg
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.
The mean dosage of Arcoxia® and Celebrex® during treatment was determined. For participants who stopped treatment after their initial study visit, the maximum dose recorded at their final study visit was considered when calculating their mean dosage during treatment.
Outcome measures
| Measure |
Group Arcoxia®
n=246 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=252 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Mean Dosage of Arcoxia® and Celebrex® During Treatment
|
44.1 mg/day
Standard Deviation 14.8
|
221.9 mg/day
Standard Deviation 73.1
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.
Participants requiring modifications to their Arcoxia® or Celebrex® dose regimens during their on study treatment course were identified. Dose modifications were defined as an increase, decrease followed by increase, decrease, or increase followed by decrease in the participant's daily dose; all categorizations were exclusive. If the maximum dose at discontinuation of treatment was greater than that at initiation, the participant was considered as having had an increase in dose during treatment. Alternatively, if data obtained from a participant's prescription records showed a successive lowering of dosage, the participant was considered as having had a decrease in dose during treatment. Dosages at baseline were included in the dose modification determination for treatment renewal participants.
Outcome measures
| Measure |
Group Arcoxia®
n=246 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=252 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex®
Missing data
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex®
Dose increase
|
42 Participants
|
33 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex®
Dose decrease followed by increase
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex®
Dose decrease
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex®
Dose increase followed by decrease
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 3 months prior to study entryPopulation: The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (duration of prescription)
The mean duration of prescription at enrollment for participants treated with Arcoxia® and Celebrex® was determined using the participant's record.
Outcome measures
| Measure |
Group Arcoxia®
n=149 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=119 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
n=119 Participants
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
n=157 Participants
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
n=268 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=276 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Duration of Prescription for Arcoxia® and Celebrex® at Enrollment
|
25.5 Days
Standard Deviation 18.4
|
38.1 Days
Standard Deviation 24.1
|
23.9 Days
Standard Deviation 17.6
|
41.7 Days
Standard Deviation 26.9
|
31.1 Days
Standard Deviation 22.0
|
34.0 Days
Standard Deviation 24.9
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (duration of prescription)
The total duration of treatment (DoT) with Arcoxia® or Celebrex® was determined for populations that achieved end-of study and end-of-protocol or that were categorized as lost to follow-up. Participants enumerated as end-of-study had their treatment discontinued during the protocol-specified one year of follow-up. Participants enumerated as end-of-protocol were ongoing treatment at end of the protocol-specified one year of follow-up. Participants categorized as lost to follow-up had no follow-up visit where a determination of discontinuation from treatment could be made.
Outcome measures
| Measure |
Group Arcoxia®
n=251 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=256 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Total Duration of Treatment With Arcoxia® and Celebrex®
DoT - End-of-study participants (n=215,196)
|
85.2 Days
Standard Deviation 127.1
|
117.8 Days
Standard Deviation 307.6
|
—
|
—
|
—
|
—
|
|
Total Duration of Treatment With Arcoxia® and Celebrex®
DoT - End-of-protocol participants (n=31,56)
|
472.9 Days
Standard Deviation 90.7
|
595.2 Days
Standard Deviation 456.7
|
—
|
—
|
—
|
—
|
|
Total Duration of Treatment With Arcoxia® and Celebrex®
DoT - Lost to follow-up participants (n=5,4)
|
122.4 Days
Standard Deviation 131.6
|
142.0 Days
Standard Deviation 128.8
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.
Mean maximum dosage prescribed during follow-up in participants treated with Arcoxia® or Celebrex®. Dosage is expressed as total daily dose.
Outcome measures
| Measure |
Group Arcoxia®
n=137 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=109 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
n=109 Participants
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
n=143 Participants
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
n=246 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=252 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Maximum Dosage Prescribed During Treatment With Arcoxia® and Celebrex®
|
47.1 mg/day
Standard Deviation 16.2
|
48.4 mg/day
Standard Deviation 14.7
|
228.4 mg/day
Standard Deviation 79.5
|
242.7 mg/day
Standard Deviation 86.0
|
47.7 mg/day
Standard Deviation 15.5
|
236.5 mg/day
Standard Deviation 83.4
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.
The individual reasons for discontinuation of treatment with Arcoxia® or Celebrex® were identified over the course of study through either physician selection from a pre-determined list or verbatim entry by the physician with subsequent re-codification by Sponsor.
Outcome measures
| Measure |
Group Arcoxia®
n=215 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=196 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®
Death unrelated to coxibs
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®
End of prescribed treatment
|
140 Participants
|
118 Participants
|
—
|
—
|
—
|
—
|
|
Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®
Recovery
|
16 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
|
Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®
Lack of efficacy
|
31 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
|
Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®
Intolerance
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®
Improved symptoms
|
8 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®
Surgical intervention
|
3 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®
Participant decision
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®
Physician decision
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®
Other disease detected
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®
Other - unknown reason
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®
Rheumatologist new evaluation
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®
Missing data
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.
The type of Arcoxia® or Celebrex® use during the study was classified as continuous (without interruption \>7 days) or intermittent (with interruption \>7 days) by the Investigating Physician at time of treatment discontinuation.
Outcome measures
| Measure |
Group Arcoxia®
n=215 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=194 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Type of Arcoxia® and Celebrex® Use
Missing data
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Type of Arcoxia® and Celebrex® Use
Intermittent
|
44 Participants
|
47 Participants
|
—
|
—
|
—
|
—
|
|
Type of Arcoxia® and Celebrex® Use
Continuous
|
171 Participants
|
147 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.
Use of selective cyclooxygenase-2 (COX-2) inhibitors (Arcoxia® and Celebrex®) as assessed by the Investigating Physician at time of treatment discontinuation was correlated to the overall duration of treatment experienced by the participant (i.e., intermittent or continuous selective COX-2 inhibitor use vs. total participant time on treatment). Type of use was classified as continuous (without interruption \>7 days) or intermittent (with interruption \>7 days). Four successive treatment intervals were assessed in this endpoint: 1) Up to thirty days of treatment 2) From one to three months of treatment 3) From three months to one year of treatment and 4) More than one year of treatment.
Outcome measures
| Measure |
Group Arcoxia®
n=206 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=112 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
n=75 Participants
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
n=18 Participants
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Type of Arcoxia® and Celebrex® Use According to Duration of Treatment
Missing data
|
0 Participants
127.1
|
1 Participants
307.6
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Type of Arcoxia® and Celebrex® Use According to Duration of Treatment
Intermittent
|
24 Participants
90.7
|
38 Participants
456.7
|
22 Participants
|
7 Participants
|
—
|
—
|
|
Type of Arcoxia® and Celebrex® Use According to Duration of Treatment
Continuous
|
182 Participants
131.6
|
73 Participants
128.8
|
52 Participants
|
11 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At study entry (baseline)Population: The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (BMI)
Participants' BMI was assessed at study entry by the Investigating Physician. BMI is calculated as the participant's weight in kilograms (kg) divided by height in meters squared. BMI under 18.5 is commonly considered underweight; within the range (18.5 to 25) as normal weight; within the range (25 to 30) as overweight; and over 30 as obese.
Outcome measures
| Measure |
Group Arcoxia®
n=147 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=119 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
n=120 Participants
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
n=158 Participants
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
n=266 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=278 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Mean Body Mass Index (BMI) at Study Entry in Participants Treated With Arcoxia® and Celebrex®
|
26.6 kg/m^2
Standard Deviation 5.2
|
27.1 kg/m^2
Standard Deviation 4.5
|
27.3 kg/m^2
Standard Deviation 4.5
|
27.0 kg/m^2
Standard Deviation 5.6
|
26.8 kg/m^2
Standard Deviation 4.9
|
27.1 kg/m^2
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: At study entry (baseline)Population: The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (SBP and DBP)
Mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) were assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP \<140 mmHg and DBP \<90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.
Outcome measures
| Measure |
Group Arcoxia®
n=146 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=118 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
n=116 Participants
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
n=158 Participants
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
n=264 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=274 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Mean Systolic and Diastolic Blood Pressure (BP) at Study Entry in Participants Treated With Arcoxia® and Celebrex®
SBP
|
127.4 mmHG
Standard Deviation 10.7
|
130.9 mmHG
Standard Deviation 9.9
|
127.9 mmHG
Standard Deviation 9.5
|
128.4 mmHG
Standard Deviation 8.2
|
129.0 mmHG
Standard Deviation 10.4
|
128.2 mmHG
Standard Deviation 8.8
|
|
Mean Systolic and Diastolic Blood Pressure (BP) at Study Entry in Participants Treated With Arcoxia® and Celebrex®
DBP
|
76.0 mmHG
Standard Deviation 7.0
|
76.8 mmHG
Standard Deviation 7.3
|
76.0 mmHG
Standard Deviation 7.6
|
75.1 mmHG
Standard Deviation 7.1
|
76.4 mmHG
Standard Deviation 7.1
|
75.4 mmHG
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: At study entry (baseline)Population: The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (BP)
Participants' BP (SBP/DBP) was assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP \<140 mmHg and DBP \<90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.
Outcome measures
| Measure |
Group Arcoxia®
n=149 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=119 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
n=121 Participants
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
n=158 Participants
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
n=268 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=279 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Blood Pressure at Study Entry in Participants Treated With Arcoxia® and Celebrex®
MIssing data
|
3 Participants
10.7
|
1 Participants
9.9
|
5 Participants
9.5
|
0 Participants
8.2
|
4 Participants
10.4
|
5 Participants
8.8
|
|
Blood Pressure at Study Entry in Participants Treated With Arcoxia® and Celebrex®
<120/80 mmHg
|
15 Participants
7.0
|
5 Participants
7.3
|
8 Participants
7.6
|
6 Participants
7.1
|
20 Participants
7.1
|
14 Participants
7.3
|
|
Blood Pressure at Study Entry in Participants Treated With Arcoxia® and Celebrex®
120 mmHg ≤SBP<140 mmHg and/or 80 mmHg ≤DBP<90 mmHg
|
105 Participants
|
80 Participants
|
87 Participants
|
127 Participants
|
185 Participants
|
214 Participants
|
|
Blood Pressure at Study Entry in Participants Treated With Arcoxia® and Celebrex®
140 mmHg ≤SBP<180 mmHg and/or 90 mmHg≤DBP<100 mmHg
|
26 Participants
|
33 Participants
|
21 Participants
|
25 Participants
|
59 Participants
|
46 Participants
|
|
Blood Pressure at Study Entry in Participants Treated With Arcoxia® and Celebrex®
SBP≥180 mmHg and/or DBP≥110 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At study entryPopulation: The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (medical history)
Relevant medical history of participants treated with Arcoxia® or Celebrex® was recorded by the Investigating Physician.
Outcome measures
| Measure |
Group Arcoxia®
n=149 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=119 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
n=121 Participants
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
n=158 Participants
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
n=268 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=279 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Medical History of Participants Treated With Arcoxia® and Celebrex®
Arterial hypertension (n=146,118,116,156,264,272)
|
37 Participants
|
47 Participants
|
34 Participants
|
58 Participants
|
84 Participants
|
92 Participants
|
|
Medical History of Participants Treated With Arcoxia® and Celebrex®
Acute rhinitis (n=145,115,115,157,260,272)
|
20 Participants
|
15 Participants
|
10 Participants
|
12 Participants
|
35 Participants
|
22 Participants
|
|
Medical History of Participants Treated With Arcoxia® and Celebrex®
Bronchospam (n=145,117,115,158,262,273)
|
9 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
15 Participants
|
8 Participants
|
|
Medical History of Participants Treated With Arcoxia® and Celebrex®
Urticaria (n=146,116,115,156,262,271)
|
5 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
10 Participants
|
4 Participants
|
|
Medical History of Participants Treated With Arcoxia® and Celebrex®
Peptic ulcer/bleeding (n=146,118,117,158,264,275)
|
5 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
|
Medical History of Participants Treated With Arcoxia® and Celebrex®
Angioedema (n=145,117,114,157,262,271)
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Medical History of Participants Treated With Arcoxia® and Celebrex®
Nasal polyps (n=146,116,114,158,262,272)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At study entryPopulation: The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (co-morbidities)
Associated co-morbidities at study entry (baseline) in participants treated with Arcoxia® or Celebrex® were recorded by the Investigating Physician. CHF/IHD/PAD = Congestive heart failure/Ischemic heart disease/Peripheral artery disease
Outcome measures
| Measure |
Group Arcoxia®
n=149 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=119 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
n=121 Participants
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
n=158 Participants
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
n=268 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=279 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Co-morbidities in Participants Treated With Arcoxia® and Celebrex®
Active peptic ulceration/ GI bleeding
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Co-morbidities in Participants Treated With Arcoxia® and Celebrex®
At least one co-morbidity
|
55 Participants
|
44 Participants
|
32 Participants
|
62 Participants
|
99 Participants
|
94 Participants
|
|
Co-morbidities in Participants Treated With Arcoxia® and Celebrex®
Hyperlipidemia
|
43 Participants
|
34 Participants
|
26 Participants
|
46 Participants
|
77 Participants
|
72 Participants
|
|
Co-morbidities in Participants Treated With Arcoxia® and Celebrex®
Diabetes
|
14 Participants
|
11 Participants
|
6 Participants
|
22 Participants
|
25 Participants
|
28 Participants
|
|
Co-morbidities in Participants Treated With Arcoxia® and Celebrex®
Hepatic insufficiency
|
4 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
|
Co-morbidities in Participants Treated With Arcoxia® and Celebrex®
Inflammatory bowel disease
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
4 Participants
|
|
Co-morbidities in Participants Treated With Arcoxia® and Celebrex®
CHF/IHD/PAD
|
1 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
9 Participants
|
|
Co-morbidities in Participants Treated With Arcoxia® and Celebrex®
Missing data
|
5 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At study entryPopulation: The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (past treatments)
'Significant' treatments that preceded the use of selective COX-2 inhibitors (Arcoxia® or Celebrex®) were identified using a closed-ended (yes/ no/ do not know) questionnaire. Significant is defined as associated with a chronic disease or having a potential link with participant's current use of a selective COX-2 inhibitors (Arcoxia® or Celebrex®). ARBs = Angiotensin 2 receptor blockers. ACEIs = Angiotensin-converting enzyme inhibitors. SSRIs = Selective serotonin reuptake Inhibitors. PAIs = Platelet aggregation inhibitors.
Outcome measures
| Measure |
Group Arcoxia®
n=149 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=119 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
n=121 Participants
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
n=158 Participants
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
n=268 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=279 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®
At least one treatment (n=146,118,117,158,264,275)
|
102 Participants
|
75 Participants
|
67 Participants
|
118 Participants
|
177 Participants
|
185 Participants
|
|
Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®
Proton-pump inhibitors (n=146,115,116,156,261,272)
|
58 Participants
|
43 Participants
|
30 Participants
|
65 Participants
|
101 Participants
|
95 Participants
|
|
Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®
Hypolipidemic agents (n=146,116,117,156,262,273)
|
39 Participants
|
32 Participants
|
24 Participants
|
45 Participants
|
71 Participants
|
69 Participants
|
|
Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®
ARBs (n=144,115,116,155,259,271)
|
22 Participants
|
29 Participants
|
23 Participants
|
37 Participants
|
51 Participants
|
60 Participants
|
|
Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®
Diuretics (N=146,117,117,156,263,273)
|
16 Participants
|
24 Participants
|
10 Participants
|
29 Participants
|
40 Participants
|
39 Participants
|
|
Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®
ACEIs (n=145,116,117,157,261,274)
|
11 Participants
|
22 Participants
|
13 Participants
|
20 Participants
|
33 Participants
|
33 Participants
|
|
Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®
SSRIs (n=146,116,117,158,262,275)
|
15 Participants
|
15 Participants
|
8 Participants
|
25 Participants
|
30 Participants
|
33 Participants
|
|
Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®
Anti-diabetic agents (n=146,115,117,158,261,275)
|
14 Participants
|
8 Participants
|
6 Participants
|
19 Participants
|
22 Participants
|
25 Participants
|
|
Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®
Histamine H2 blockers (n=146,117,117,156,263,273)
|
14 Participants
|
14 Participants
|
7 Participants
|
20 Participants
|
28 Participants
|
27 Participants
|
|
Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®
PAIs (n=146,118,117,158,264,275)
|
5 Participants
|
8 Participants
|
6 Participants
|
8 Participants
|
13 Participants
|
14 Participants
|
|
Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®
Oral anticoagulants (n=146,118,117,158,264,275)
|
1 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
9 Participants
|
|
Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®
Alpha-blockers (n=146,116,117,157,262,274)
|
1 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: At study entryPopulation: The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (co-prescriptions at entry)
Concomitant medications prescribed to participants treated with Arcoxia® and Celebrex® were collected via the physician prescription note at time of participant's study entry. NSAIDS = Non-steroidal anti-inflammatory agents.
Outcome measures
| Measure |
Group Arcoxia®
n=149 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=119 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
n=121 Participants
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
n=158 Participants
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
n=268 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=279 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Analgesics
|
52 Participants
|
66 Participants
|
38 Participants
|
75 Participants
|
118 Participants
|
113 Participants
|
|
Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Missing data
|
15 Participants
|
22 Participants
|
3 Participants
|
23 Participants
|
37 Participants
|
26 Participants
|
|
Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
At least one treatment
|
95 Participants
|
89 Participants
|
73 Participants
|
120 Participants
|
184 Participants
|
193 Participants
|
|
Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Cardiovascular agents
|
30 Participants
|
40 Participants
|
31 Participants
|
59 Participants
|
70 Participants
|
90 Participants
|
|
Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Digestive system agents
|
37 Participants
|
33 Participants
|
22 Participants
|
61 Participants
|
70 Participants
|
83 Participants
|
|
Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Nervous system agents
|
17 Participants
|
24 Participants
|
14 Participants
|
45 Participants
|
41 Participants
|
59 Participants
|
|
Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
NSAIDS
|
25 Participants
|
21 Participants
|
15 Participants
|
28 Participants
|
46 Participants
|
43 Participants
|
|
Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Rheumatologic agents
|
17 Participants
|
21 Participants
|
23 Participants
|
29 Participants
|
38 Participants
|
52 Participants
|
|
Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Metabolic system agents
|
14 Participants
|
23 Participants
|
11 Participants
|
38 Participants
|
37 Participants
|
49 Participants
|
|
Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Respiratory system agents
|
9 Participants
|
16 Participants
|
7 Participants
|
21 Participants
|
25 Participants
|
28 Participants
|
|
Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Hormonal agents
|
8 Participants
|
13 Participants
|
6 Participants
|
15 Participants
|
21 Participants
|
21 Participants
|
|
Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Hematologic agents
|
1 Participants
|
10 Participants
|
6 Participants
|
16 Participants
|
11 Participants
|
22 Participants
|
|
Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Urinary-genital system agents
|
4 Participants
|
4 Participants
|
6 Participants
|
12 Participants
|
8 Participants
|
18 Participants
|
|
Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Dermatological agents
|
7 Participants
|
1 Participants
|
4 Participants
|
14 Participants
|
8 Participants
|
18 Participants
|
|
Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Anti-infectious agents
|
4 Participants
|
4 Participants
|
2 Participants
|
12 Participants
|
8 Participants
|
14 Participants
|
|
Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Other not-classified
|
6 Participants
|
5 Participants
|
5 Participants
|
23 Participants
|
11 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: All participants in compliance with study inclusion criteria with at least one follow-up visit (with an available prescription file) other than the end-of-study visit were used for analysis of the endpoint
Concomitant medications prescribed during the course of follow-up to participants treated with Arcoxia® and Celebrex® were extracted from participants' medical records. NSAIDS = Non-steroidal anti-inflammatory agents.
Outcome measures
| Measure |
Group Arcoxia®
n=104 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=116 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
Missing data
|
26 Participants
|
38 Participants
|
—
|
—
|
—
|
—
|
|
Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
At least one treatment
|
75 Participants
|
65 Participants
|
—
|
—
|
—
|
—
|
|
Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
Analgesics
|
58 Participants
|
55 Participants
|
—
|
—
|
—
|
—
|
|
Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
Cardiovascular agents
|
41 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
Digestive system agents
|
39 Participants
|
36 Participants
|
—
|
—
|
—
|
—
|
|
Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
Nervous system agents
|
25 Participants
|
32 Participants
|
—
|
—
|
—
|
—
|
|
Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
Respiratory system agents
|
32 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
|
Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
Metabolic system agents
|
28 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
|
Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
Rheumatologic agents
|
19 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
NSAIDS
|
17 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
|
Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
Anti-infectious agents
|
16 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
|
Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
Hormonal agents
|
12 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
Dermatological agents
|
13 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
Hematologic agents
|
14 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
Urinary-genital system agents
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
Other
|
17 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 months prior to study entryPopulation: The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (other prior agents)
Other prescribed agents for the same study indication within 3 months preceding the decision to initiate treatment with selective COX-2 inhibitors (Arcoxia® or Celebrex®) were determined using the participant's medical record. NSAIDS = Non-steroidal inflammatory agents.
Outcome measures
| Measure |
Group Arcoxia®
n=149 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=119 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
n=121 Participants
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
n=158 Participants
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
n=268 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=279 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Number of Participants Treated With Other Agents Prior to Initiation of Arcoxia® and Celebrex®
At least one treatment (n=146,118,117,158,264,275)
|
93 Participants
|
86 Participants
|
62 Participants
|
102 Participants
|
179 Participants
|
164 Participants
|
|
Number of Participants Treated With Other Agents Prior to Initiation of Arcoxia® and Celebrex®
Paracetamol (n=146,118,117,158,264,275)
|
83 Participants
|
82 Participants
|
54 Participants
|
90 Participants
|
165 Participants
|
144 Participants
|
|
Number of Participants Treated With Other Agents Prior to Initiation of Arcoxia® and Celebrex®
NSAIDS (n=146,118,117,158,264,275)
|
33 Participants
|
19 Participants
|
19 Participants
|
23 Participants
|
52 Participants
|
42 Participants
|
|
Number of Participants Treated With Other Agents Prior to Initiation of Arcoxia® and Celebrex®
Analgesics (n=146,118,117,158,264,275)
|
4 Participants
|
4 Participants
|
1 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants Treated With Other Agents Prior to Initiation of Arcoxia® and Celebrex®
Corticosteroids (n=140,107,111,152,247,263)
|
7 Participants
|
3 Participants
|
6 Participants
|
13 Participants
|
10 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.
Participants who switched to another NSAID or other therapy for the same reason for prescription upon discontinuation of treatment with Arcoxia® or Celebrex® were determined.
Outcome measures
| Measure |
Group Arcoxia®
n=215 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=196 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Number of Participants Switching to Another Treatment With the Same Reason for Prescription
Prescription of a new treatment
|
33 Participants
|
29 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Switching to Another Treatment With the Same Reason for Prescription
NSAIDS
|
22 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Switching to Another Treatment With the Same Reason for Prescription
Analgesics
|
9 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Switching to Another Treatment With the Same Reason for Prescription
Other (TNF-alpha inhibitors, corticosteroids)
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At study entryPopulation: The safety population consisting of all participants who enrolled in the study with data of sufficient quality for analysis of the endpoint (contraindications)
Participants noted with contraindications for use of Arcoxia® according to the MA during initiation of treatment are described. CHF = congestive heart failure. HA = hepatic impairment. IBD = inflammatory bowel disease. IHD = ischemic heart disease. PAD = peripheral artery disease.
Outcome measures
| Measure |
Group Arcoxia®
n=149 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=119 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
n=268 Participants
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Contraindications for Use of Arcoxia®
History of bronchospasm (n=145,117,262)
|
9 Participants
|
6 Participants
|
15 Participants
|
—
|
—
|
—
|
|
Number of Participants With Contraindications for Use of Arcoxia®
History of urticaria (n=146,116,262)
|
5 Participants
|
5 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants With Contraindications for Use of Arcoxia®
Presence of IBD (n=146,118,264)
|
2 Participants
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Contraindications for Use of Arcoxia®
Presence of CHF (n=146,118,264)
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Contraindications for Use of Arcoxia®
Presence of IHD and/or PAD (n=142,118,260)
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Contraindications for Use of Arcoxia®
History of allergic reaction (n=145,118,263)
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Contraindications for Use of Arcoxia®
History of nasal polyps (n=146,116,262)
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Contraindications for Use of Arcoxia®
Blood pressure not controlled (n=146,118,264)
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Contraindications for Use of Arcoxia®
History of angioedema (n=145,117,262)
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Contraindications for Use of Arcoxia®
Patients with severe HA (n=146,118,264)
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Contraindications for Use of Arcoxia®
<16 years of age (n=149,119,268)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Contraindications for Use of Arcoxia®
Pregnancy or lactation (n=92,73,165)
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Contraindications for Use of Arcoxia®
Creatinine clearance <30 ml/min (n=125,108,233)
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Contraindications for Use of Arcoxia®
At least one contraindication (n=122,100,122)
|
36 Participants
|
34 Participants
|
70 Participants
|
—
|
—
|
—
|
|
Number of Participants With Contraindications for Use of Arcoxia®
One total contraindication (n=36,34,70)
|
29 Participants
|
32 Participants
|
61 Participants
|
—
|
—
|
—
|
|
Number of Participants With Contraindications for Use of Arcoxia®
Two total contraindications (n=36,34,70)
|
7 Participants
|
2 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Number of Participants With Contraindications for Use of Arcoxia®
History of acute rhinitis (n=145,115,260)
|
20 Participants
|
15 Participants
|
35 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The safety population consisting of all participants who enrolled in the study
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Outcome measures
| Measure |
Group Arcoxia®
n=268 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=279 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced at Least One Adverse Event
|
10 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The safety population consisting of all participants who enrolled in the study
Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Outcome measures
| Measure |
Group Arcoxia®
n=268 Participants
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
n=279 Participants
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Initiation
Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex® - Renewal
Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Arcoxia®
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
Group Celebrex®
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
Group Arcoxia®
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group Celebrex®
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place