Trial Outcomes & Findings for Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH (NCT NCT00439946)
NCT ID: NCT00439946
Last Updated: 2024-01-03
Results Overview
The administration of the 6MWD test and specifications of the testing area were consistent with the American Thoracic Society guidelines and the usual practice of the investigative site \[American Thoracic Society (ATS) guidelines; 2002\].
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
8 participants
Primary outcome timeframe
Week 8
Results posted on
2024-01-03
Participant Flow
Screening was initiated by investigators at participating study sites 7 to 28 days prior to the Baseline visit. The first subject was enrolled on February 20, 2007 and the last subject completed the study on September 30, 2009. After an extended recruitment period during which no new subjects were enrolled, the study was closed in 2011.
A total of ten subjects were screened. Eight were enrolled and completed the study. One subject withdrew their consent prior to enrolling. The second subject failed screening due to low hemoglobin levels. Once enrolled, baseline assessments were completed, and patients underwent rapid switch from epoprostenol to treprostinil infusion.
Participant milestones
| Measure |
Treprostinil
All Subjects transitioned from IV epoprostenol to IV treprostinil initiated to deliver a dose 20% higher than the epoprostenol dose on a ng/kg/min basis. IV treprostinil dosing was titrated without restriction during the eight week follow-up period per the investigator's judgment to optimize the dose for symptomatic benefit based on clinical signs / symptoms, exercise capacity and tolerability.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
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8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH
Baseline characteristics by cohort
| Measure |
Treprostinil
n=8 Participants
All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
49.5 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=93 Participants
|
|
Pulmonary Arterial Hypertension (PAH) etiology
IPAH
|
6 participants
n=93 Participants
|
|
Pulmonary Arterial Hypertension (PAH) etiology
cardiovascular disease (CVD)
|
2 participants
n=93 Participants
|
|
Years since PAH diagnosis
|
7 years
n=93 Participants
|
|
World Health Organization (WHO) functional class at time of transition
Class II
|
6 participants
n=93 Participants
|
|
World Health Organization (WHO) functional class at time of transition
Class III
|
2 participants
n=93 Participants
|
|
epoprostenol dose
|
34.05 ng/kg/min
n=93 Participants
|
|
Baseline 6 Minute Walk Distance (6MWD)
|
390.5 meters
n=93 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Two subjects did not have Baseline 6MWTs and were excluded from this analysis.
The administration of the 6MWD test and specifications of the testing area were consistent with the American Thoracic Society guidelines and the usual practice of the investigative site \[American Thoracic Society (ATS) guidelines; 2002\].
Outcome measures
| Measure |
Treprostinil
n=6 Participants
All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
|
|---|---|
|
Change From Baseline at Week 8 in 6-Minute Walk Distance (6MWD)
|
-1.2 meters
Standard Deviation 37.0
|
SECONDARY outcome
Timeframe: Week 8Population: Two subjects did not have Baseline Borg scores and were excluded from this analysis.
The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-Minute Walk Test. Scores range from 0 (for the best condition) to 10 (for the worst condition).
Outcome measures
| Measure |
Treprostinil
n=6 Participants
All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
|
|---|---|
|
Change From Baseline at Week 8 in Borg Dyspnea Score Immediately After Six Minute Walk Test
|
0.08 units on a scale
Standard Deviation 1.74
|
SECONDARY outcome
Timeframe: Week 8Population: All Subjects transitioned from IV epoprostenol to IV treprostinil were included.
WHO functional class is a system to help clinicians determine how limited a patient is in their ability to do the activities of daily living. The scale ranges from class I to class IV. In general, patients with more severe Pulmonary Hypertension (PH) tend to have a higher functional class.
Outcome measures
| Measure |
Treprostinil
n=8 Participants
All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
|
|---|---|
|
Change From Baseline at Week 8 in World Health Organization (WHO) Functional Classification
Improved
|
3 participants
|
|
Change From Baseline at Week 8 in World Health Organization (WHO) Functional Classification
No change
|
3 participants
|
|
Change From Baseline at Week 8 in World Health Organization (WHO) Functional Classification
Worsened
|
2 participants
|
SECONDARY outcome
Timeframe: Week 8Population: All Subjects transitioned from IV epoprostenol to IV treprostinil were included.
The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.
Outcome measures
| Measure |
Treprostinil
n=8 Participants
All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
|
|---|---|
|
Change From Baseline at Week 8 in Symptoms of PAH- Fatigue
Improved
|
1 participants
|
|
Change From Baseline at Week 8 in Symptoms of PAH- Fatigue
No change
|
4 participants
|
|
Change From Baseline at Week 8 in Symptoms of PAH- Fatigue
Worsened
|
3 participants
|
SECONDARY outcome
Timeframe: Week 8Population: All Subjects transitioned from IV epoprostenol to IV treprostinil were included
The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.
Outcome measures
| Measure |
Treprostinil
n=8 Participants
All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
|
|---|---|
|
Change From Baseline at Week 8 in Symptoms of PAH- Dyspnea
Improved
|
1 participants
|
|
Change From Baseline at Week 8 in Symptoms of PAH- Dyspnea
No change
|
6 participants
|
|
Change From Baseline at Week 8 in Symptoms of PAH- Dyspnea
Worsened
|
1 participants
|
SECONDARY outcome
Timeframe: Week 8Population: All Subjects transitioned from IV epoprostenol to IV treprostinil were included
The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.
Outcome measures
| Measure |
Treprostinil
n=8 Participants
All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
|
|---|---|
|
Change From Baseline at Week 8 in Symptoms of PAH- Edema
Improved
|
0 participants
|
|
Change From Baseline at Week 8 in Symptoms of PAH- Edema
No change
|
6 participants
|
|
Change From Baseline at Week 8 in Symptoms of PAH- Edema
Worsened
|
2 participants
|
SECONDARY outcome
Timeframe: Week 8Population: All Subjects transitioned from IV epoprostenol to IV treprostinil were included
The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.
Outcome measures
| Measure |
Treprostinil
n=8 Participants
All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
|
|---|---|
|
Change From Baseline at Week 8 in PAH Symptoms- Orthopnea
Improved
|
0 participants
|
|
Change From Baseline at Week 8 in PAH Symptoms- Orthopnea
No change
|
8 participants
|
|
Change From Baseline at Week 8 in PAH Symptoms- Orthopnea
Worsened
|
0 participants
|
SECONDARY outcome
Timeframe: Week 8Population: All Subjects transitioned from IV epoprostenol to IV treprostinil were included.
The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.
Outcome measures
| Measure |
Treprostinil
n=8 Participants
All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
|
|---|---|
|
Change From Baseline at Week 8 in PAH Symptoms- Dizziness
Improved
|
1 participants
|
|
Change From Baseline at Week 8 in PAH Symptoms- Dizziness
No change
|
5 participants
|
|
Change From Baseline at Week 8 in PAH Symptoms- Dizziness
Worsened
|
2 participants
|
SECONDARY outcome
Timeframe: Week 8Population: All Subjects transitioned from IV epoprostenol to IV treprostinil were included.
The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.
Outcome measures
| Measure |
Treprostinil
n=8 Participants
All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
|
|---|---|
|
Change From Baseline at Week 8 in PAH Symptoms- Syncope
Improved
|
0 participants
|
|
Change From Baseline at Week 8 in PAH Symptoms- Syncope
No change
|
8 participants
|
|
Change From Baseline at Week 8 in PAH Symptoms- Syncope
Worsened
|
0 participants
|
SECONDARY outcome
Timeframe: Week 8Population: All Subjects transitioned from IV epoprostenol to IV treprostinil were included.
The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.
Outcome measures
| Measure |
Treprostinil
n=8 Participants
All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
|
|---|---|
|
Change From Baseline at Week 8 in PAH Symptoms- Chest Pain
Improved
|
0 participants
|
|
Change From Baseline at Week 8 in PAH Symptoms- Chest Pain
No change
|
7 participants
|
|
Change From Baseline at Week 8 in PAH Symptoms- Chest Pain
Worsened
|
1 participants
|
SECONDARY outcome
Timeframe: Week 8A Drug Administration Activities Diary, used by subjects to record in detail the amount of time (in minutes) spent on specifically-defined drug preparation/administration activities (e.g. diluting drug, preparing reservoir, and changing tubing), was completed over a 7-day period during the Screening period while on epoprostenol and repeated at Week 7 following transition to Remodulin.
Outcome measures
| Measure |
Treprostinil
n=8 Participants
All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
|
|---|---|
|
Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Gather/set-up
|
4.4 minutes
Standard Deviation 32.6
|
|
Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Prepare Drug
|
-50.4 minutes
Standard Deviation 35.3
|
|
Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Connect drug
|
-13.1 minutes
Standard Deviation 38.1
|
|
Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Change dressing
|
3.9 minutes
Standard Deviation 10.8
|
|
Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Total Time
|
-55.3 minutes
Standard Deviation 77.0
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: One subject was missing a questionnaire page of the CAMPHOR; Therefore, the component score of
The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR), a validated PAH-specific instrument consisting of 65 items used to assess symptoms, functioning and QOL. The CAMPHOR was completed at Baseline and at Week 8. The CAMPHOR consists of 3 scales: 1. A 25-item overall symptoms scale scored 0-25, with a higher score indicating the presence of more symptoms. 2. A 15 item Activity/Functioning scale scored 0-30, where a low score indicates good functioning. 3. A 25-item QoL scale scored 0-25, with a high score indicating poor QoL. Additionally, a total score was recorded by adding up the the scores from the 3 above scales. The Symptom and QoL scales have dichotomous ('True'/'Not true') response options while the Activity/Functioning scale has three-point ('Able to do on own without difficulty'/'Able to do on own with difficulty'/'Unable to do on own') response options. The CAMPHOR score range can be from 0 to 80. A reduction in score denotes improved heath status.
Outcome measures
| Measure |
Treprostinil
n=8 Participants
All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
|
|---|---|
|
Change From Baseline at Week 8 in Score on Quality of Life (QOL) Questionnaire - The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)
CAMPHOR- Symptom Score
|
-2.1 units on a scale
Standard Deviation 4.3
|
|
Change From Baseline at Week 8 in Score on Quality of Life (QOL) Questionnaire - The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)
CAMPHOR- Activity Score
|
1.0 units on a scale
Standard Deviation 3.9
|
|
Change From Baseline at Week 8 in Score on Quality of Life (QOL) Questionnaire - The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)
CAMPHOR- Quality of Life Score
|
-3.1 units on a scale
Standard Deviation 3.7
|
|
Change From Baseline at Week 8 in Score on Quality of Life (QOL) Questionnaire - The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)
CAMPHOR- Total Score
|
-4.3 units on a scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: All 8 participants are included.
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-question questionnaire that measures the level of satisfaction or dissatisfaction patients have with their study medication in 4 areas: effectiveness (3 questions), side effects (5 questions), convenience (3 questions), and global satisfaction (3 questions). With the exception of the first side effects question (a yes or no question), all items have 5 or 7 responses which are scored from 1 (least satisfied) to 5 or 7 (most satisfied). A total score is then summed for each domain on the following scales: effectiveness 1-21, side effects 1-20, convenience 1-21, and global satisfaction 1-17. The TSQM score range can be from 0 to 100. Lower total scores in each domain indicate dissatisfaction with the study medication and higher total scores indicate satisfaction.
Outcome measures
| Measure |
Treprostinil
n=8 Participants
All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
|
|---|---|
|
Change From Baseline at Week 8 in Score on Treatment Satisfaction Questionnaire- The Treatment Satisfaction Questionnaire for Medication (TSQM)
TSQM- Effectiveness Score
|
-4.9 units on a scale
Standard Deviation 22.9
|
|
Change From Baseline at Week 8 in Score on Treatment Satisfaction Questionnaire- The Treatment Satisfaction Questionnaire for Medication (TSQM)
TSQM- Side-Effects Score
|
7.0 units on a scale
Standard Deviation 19.0
|
|
Change From Baseline at Week 8 in Score on Treatment Satisfaction Questionnaire- The Treatment Satisfaction Questionnaire for Medication (TSQM)
TSQM- Conveniences Score
|
29.2 units on a scale
Standard Deviation 21.4
|
|
Change From Baseline at Week 8 in Score on Treatment Satisfaction Questionnaire- The Treatment Satisfaction Questionnaire for Medication (TSQM)
TSQM- Global Satisfaction Score
|
-11.6 units on a scale
Standard Deviation 31.7
|
SECONDARY outcome
Timeframe: Week 8A Patient Global Impression of Change Questionnaire, which consists of three items that ask the subject to rate changes (much better, somewhat better, about the same, somewhat worse, much worse) in their symptoms of PAH, the amount of time spent on activities associated with preparing and administering PAH therapy, and their satisfaction with their PAH therapy since transitioning from epoprostenol to intravenous Remodulin was conducted at Week 8 only and responses are reported as frequency distributions.
Outcome measures
| Measure |
Treprostinil
n=8 Participants
All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
|
|---|---|
|
Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
Symptoms- Much Better
|
4 participants
|
|
Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
Symptoms- Somewhat Better
|
1 participants
|
|
Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
Symptoms- About The Same
|
1 participants
|
|
Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
Symptoms- Somewhat Worse
|
1 participants
|
|
Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
Symptoms- Much Worse
|
1 participants
|
|
Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
Time Spent- Much Less
|
5 participants
|
|
Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
Time Spent- Somewhat Less
|
2 participants
|
|
Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
Time Spent- About The Same
|
0 participants
|
|
Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
Time Spent- Somewhat More
|
1 participants
|
|
Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
Time Spent- Much More
|
0 participants
|
|
Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
Satisfaction- Much More Satisfied
|
4 participants
|
|
Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
Satisfaction- More Satisfied
|
2 participants
|
|
Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
Satisfaction- About The Same
|
1 participants
|
|
Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
Satisfaction- Less Satisfied
|
0 participants
|
|
Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
Satisfaction- Much Less Satisfied
|
1 participants
|
Adverse Events
Treprostinil
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treprostinil
n=8 participants at risk
All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
|
|---|---|
|
Infections and infestations
central line infection
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Cardiac disorders
Fluid overload
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Cardiac disorders
Right ventricular failure
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
Other adverse events
| Measure |
Treprostinil
n=8 participants at risk
All Subjects transitioned from IV epoprostenol to IV treprostinil.
treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
75.0%
6/8 • Number of events 6 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Nervous system disorders
Headache
|
75.0%
6/8 • Number of events 7 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
General disorders
Fatigue
|
62.5%
5/8 • Number of events 5 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
4/8 • Number of events 5 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
6/8 • Number of events 6 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
75.0%
6/8 • Number of events 9 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
37.5%
3/8 • Number of events 3 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Vascular disorders
Flushing
|
37.5%
3/8 • Number of events 3 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
2/8 • Number of events 4 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Vascular disorders
Hypotension
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Infections and infestations
Influenza
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
General disorders
Nasal congestion
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
General disorders
Oedema peripheral
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
25.0%
2/8 • Number of events 3 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Immune system disorders
Pyrexia
|
25.0%
2/8 • Number of events 3 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Gastrointestinal disorders
Retching
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Metabolism and nutrition disorders
Fluid retention
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Nervous system disorders
Restless legs syndrome
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Gastrointestinal disorders
Abdominal distention
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
General disorders
Chest pain
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
General disorders
Chills
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
General disorders
Catheter site erythema
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
General disorders
Catheter site swelling
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Immune system disorders
Hypersensitivity
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Investigations
International normalised ratio increased
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Musculoskeletal and connective tissue disorders
Hypokalaemia
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Nervous system disorders
Dysarthria
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Nervous system disorders
Somnolence
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Reproductive system and breast disorders
Productive cough
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the results of this trial must be consistent with the United Therapeutics publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER