Trial Outcomes & Findings for Cardiovascular Events Based On Statin Initiation In The Elderly (NCT NCT01304641)
NCT ID: NCT01304641
Last Updated: 2021-02-21
Results Overview
CV events were defined as an inpatient or emergency department admission for heart failure (HF), myocardial infarction (MI), ischemic heart disease (IHD), cerebrovascular disease, peripheral vascular disease (PVD), aortic aneurysm, and/or revascularization. CV events were identified using medical claims.
COMPLETED
31603 participants
At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
2021-02-21
Participant Flow
Participant milestones
| Measure |
Atorvastatin
Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
|
Simvastatin
Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
|
|---|---|---|
|
Overall Study
STARTED
|
11470
|
20132
|
|
Overall Study
COMPLETED
|
11470
|
20132
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cardiovascular Events Based On Statin Initiation In The Elderly
Baseline characteristics by cohort
| Measure |
Atorvastatin
n=11470 Participants
Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
|
Simvastatin
n=20132 Participants
Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
|
Total
n=31602 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
65 to 74 years
|
8008 Participants
n=5 Participants
|
13369 Participants
n=7 Participants
|
21377 Participants
n=5 Participants
|
|
Age, Customized
75 to 84 years
|
2937 Participants
n=5 Participants
|
5790 Participants
n=7 Participants
|
8727 Participants
n=5 Participants
|
|
Age, Customized
Greater than and equal to (>=) 85 years
|
525 Participants
n=5 Participants
|
973 Participants
n=7 Participants
|
1498 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6922 Participants
n=5 Participants
|
12070 Participants
n=7 Participants
|
18992 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4548 Participants
n=5 Participants
|
8062 Participants
n=7 Participants
|
12610 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)Population: Evaluable analysis population included all participants who met inclusion criteria.
CV events were defined as an inpatient or emergency department admission for heart failure (HF), myocardial infarction (MI), ischemic heart disease (IHD), cerebrovascular disease, peripheral vascular disease (PVD), aortic aneurysm, and/or revascularization. CV events were identified using medical claims.
Outcome measures
| Measure |
Atorvastatin
n=11470 Participants
Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
|
Simvastatin
n=20132 Participants
Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
|
|---|---|---|
|
Number of Participants With Post-index Cardiovascular (CV) Events
|
700 Participants
|
1012 Participants
|
PRIMARY outcome
Timeframe: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)Population: Evaluable analysis population included all participants who met inclusion criteria.
Hazard ratio of atorvastatin versus simvastatin for first CV event. Hazard ratio of atorvastatin versus simvastatin was obtained from a Cox proportional hazards model.
Outcome measures
| Measure |
Atorvastatin
n=11470 Participants
Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
|
Simvastatin
n=20132 Participants
Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
|
|---|---|---|
|
Hazard Ratio for First Cardiovascular (CV) Event
Number of participants with event
|
700 Participants
|
1012 Participants
|
|
Hazard Ratio for First Cardiovascular (CV) Event
Number of participants without event
|
10770 Participants
|
19120 Participants
|
SECONDARY outcome
Timeframe: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)Population: Evaluable analysis population included all participants who met inclusion criteria. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
Outcome measures
| Measure |
Atorvastatin
n=887 Participants
Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
|
Simvastatin
n=1678 Participants
Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
|
|---|---|---|
|
Low-density Lipoprotein Cholesterol (LDL-C)
|
94.07 milligram/deciliter (mg/dL)
Standard Deviation 24.50
|
98.03 milligram/deciliter (mg/dL)
Standard Deviation 25.56
|
SECONDARY outcome
Timeframe: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)Population: Evaluable analysis population included all participants who met inclusion criteria.
The first observed study medication fill during the participation identification period was defined as the index drug. The initial dose of the index drug was determined based on the pharmacy claims.
Outcome measures
| Measure |
Atorvastatin
n=11470 Participants
Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
|
Simvastatin
n=20132 Participants
Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
|
|---|---|---|
|
Mean Dose
|
19.46 mg
Standard Deviation 15.91
|
28.36 mg
Standard Deviation 18.60
|
SECONDARY outcome
Timeframe: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)Population: Evaluable analysis population included all participants who met inclusion criteria.
Index dose was categorized as low dose (atorvastatin 10 mg, simvastatin up to 20 mg), medium dose (atorvastatin 20 mg, simvastatin 40 mg), and high dose (atorvastatin 40 or 80 mg, simvastatin 80 mg).
Outcome measures
| Measure |
Atorvastatin
n=11470 Participants
Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
|
Simvastatin
n=20132 Participants
Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
|
|---|---|---|
|
Number of Participants Per Dose
High dose
|
1891 Participants
|
1020 Participants
|
|
Number of Participants Per Dose
Low dose
|
5639 Participants
|
12344 Participants
|
|
Number of Participants Per Dose
Medium dose
|
3940 Participants
|
6768 Participants
|
SECONDARY outcome
Timeframe: Index date (baseline) up to end of study (28 February 2009)Population: Evaluable analysis population included all participants who met inclusion criteria.
Post-index period included time during which participants were observed for a minimum of 3 months following index date (fill date on which first observed atorvastatin or simvastatin was filled during the participant identification period) until disenrollment or end of study treatment (28 February 2009).
Outcome measures
| Measure |
Atorvastatin
n=11470 Participants
Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
|
Simvastatin
n=20132 Participants
Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
|
|---|---|---|
|
Length of Post-index Period
|
519.10 Days
Standard Deviation 251.38
|
448.41 Days
Standard Deviation 238.11
|
SECONDARY outcome
Timeframe: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)Population: Evaluable analysis population included all participants who met inclusion criteria.
Percentage of participants who adhered to index therapy was evaluated. Treatment adherence was defined as the number of days covered by index medication divided by the number of days in the post-index period, expressed as a percentage.
Outcome measures
| Measure |
Atorvastatin
n=11470 Participants
Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
|
Simvastatin
n=20132 Participants
Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
|
|---|---|---|
|
Percentage of Participants Who Adhered to Index Therapy
Less than 80 percent
|
64.92 Percentage of participants
|
57.32 Percentage of participants
|
|
Percentage of Participants Who Adhered to Index Therapy
Greater than or equal to 80 percent
|
35.08 Percentage of participants
|
42.68 Percentage of participants
|
Adverse Events
Atorvastatin
Simvastatin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER