Trial Outcomes & Findings for The Association Between Dopamine Agonists and Cardiac Valvulopathy, Fibrosis and Other Cardiopulmonary Events (NCT NCT01052948)
NCT ID: NCT01052948
Last Updated: 2011-03-23
Results Overview
Occurrence of: unspecified acute edema of lung, heart failure, acute pulmonary heart disease, or acute cor pulmonale
Recruitment status
COMPLETED
Target enrollment
86939 participants
Primary outcome timeframe
Up to 12 years
Results posted on
2011-03-23
Participant Flow
Noninterventional retrospective cohort study.
Participant milestones
| Measure |
Dopamine Agonist (Cohort 1)
Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
|
Levodopa (Cohort 2)
Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase \[COMT\] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
|
Hyperprolactinemia (Cohort 3)
Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
|
Healthy Controls (Cohort 4)
Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
27812
|
14669
|
15147
|
29311
|
|
Overall Study
COMPLETED
|
27812
|
14669
|
15147
|
29311
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Association Between Dopamine Agonists and Cardiac Valvulopathy, Fibrosis and Other Cardiopulmonary Events
Baseline characteristics by cohort
| Measure |
Dopamine Agonist (Cohort 1)
n=27812 Participants
Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
|
Levodopa (Cohort 2)
n=14669 Participants
Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase \[COMT\] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
|
Hyperprolactinemia (Cohort 3)
n=15147 Participants
Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
|
Healthy Controls (Cohort 4)
n=29311 Participants
Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
|
Total
n=86939 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
48.7 years
STANDARD_DEVIATION 20.1 • n=5 Participants
|
76.8 years
STANDARD_DEVIATION 0.1 • n=7 Participants
|
40.0 years
STANDARD_DEVIATION 0.1 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 0.1 • n=4 Participants
|
52.0 years
STANDARD_DEVIATION 21.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
22084 Participants
n=5 Participants
|
7666 Participants
n=7 Participants
|
13398 Participants
n=5 Participants
|
21992 Participants
n=4 Participants
|
65140 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5728 Participants
n=5 Participants
|
7003 Participants
n=7 Participants
|
1749 Participants
n=5 Participants
|
7319 Participants
n=4 Participants
|
21799 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 12 yearsPopulation: Per protocol.
Occurrence of: mitral stenosis with insufficiency, other unspecified mitral valve diseases, mitral or aortic valve stenosis, insufficiency, or disorders, multiple involvement of mitral and aortic valves, mitral and aortic valve diseases, unspecified, diseases of tricuspid valve, tricuspid valve disorders, specified as nonrheumatic, pulmonary valve disorders, endocarditis, valve unspecified, endomyocardial fibrosis, endocardial fibroelastosis, other primary or secondary cardiomyopathies, cardiomyopathy, functional and undiagnosed cardiac murmurs, other abnormal heart sounds.
Outcome measures
| Measure |
Dopamine Agonist (Cohort 1)
n=27812 Participants
Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
|
Levodopa (Cohort 2)
n=14669 Participants
Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase \[COMT\] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
|
Hyperprolactinemia (Cohort 3)
n=15147 Participants
Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
|
Healthy Controls (Cohort 4)
n=29311 Participants
Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
|
|---|---|---|---|---|
|
Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up
|
21 Participants/10,000 Participant-Years
|
21 Participants/10,000 Participant-Years
|
NA Participants/10,000 Participant-Years
Due to limited number of exposed cases in hyperprolactinemia cohort, no additional analyses beyond exploration of cabergoline and other single products (current, past) vs non-use, and where possible, dose/duration effect could be performed.
|
52 Participants/10,000 Participant-Years
|
PRIMARY outcome
Timeframe: Up to 12 yearsPopulation: Per protocol.
Occurrence of: idiopathic retroperitoneal fibrosis, occlusion not otherwise specified (NOS) of ureter, diffuse (idiopathic) (interstitial) pulmonary fibrosis, Hamman-Rich syndrome, interstitial pneumonia (desquamative) (lymphoid), fibrosis of lung (atrophic; confluent; massive; perialveolar; peribronchial) chronic or unspecified, pulmonary or pleural fibrosis, abnormal communication between pericardial and pleural sacs, pleural fold anomaly, adhesive or constrictive pericarditis, pericardial fibrosis
Outcome measures
| Measure |
Dopamine Agonist (Cohort 1)
n=27812 Participants
Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
|
Levodopa (Cohort 2)
n=14669 Participants
Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase \[COMT\] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
|
Hyperprolactinemia (Cohort 3)
n=15147 Participants
Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
|
Healthy Controls (Cohort 4)
n=29311 Participants
Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
|
|---|---|---|---|---|
|
Number of Participants With Fibrosis Per 10,000 Participant-Years of Follow-Up
|
2 Participants/10,000 Participant-Years
|
5 Participants/10,000 Participant-Years
|
NA Participants/10,000 Participant-Years
Due to limited number of exposed cases in hyperprolactinemia cohort, no additional analyses beyond exploration of cabergoline and other single products (current, past) vs non-use, and where possible, dose/duration effect could be performed.
|
8 Participants/10,000 Participant-Years
|
PRIMARY outcome
Timeframe: Up to 12 yearsPopulation: Per protocol.
Occurrence of: unspecified acute edema of lung, heart failure, acute pulmonary heart disease, or acute cor pulmonale
Outcome measures
| Measure |
Dopamine Agonist (Cohort 1)
n=27812 Participants
Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
|
Levodopa (Cohort 2)
n=14669 Participants
Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase \[COMT\] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
|
Hyperprolactinemia (Cohort 3)
n=15147 Participants
Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
|
Healthy Controls (Cohort 4)
n=29311 Participants
Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
|
|---|---|---|---|---|
|
Number of Participants With Heart Failure Per 10,000 Participant-Years of Follow-Up
|
69 Participants/10,000 Participant-Years
|
161 Participants/10,000 Participant-Years
|
NA Participants/10,000 Participant-Years
Due to limited number of exposed cases in hyperprolactinemia cohort, no additional analyses beyond exploration of cabergoline and other single products (current, past) vs non-use, and where possible, dose/duration effect could be performed.
|
201 Participants/10,000 Participant-Years
|
PRIMARY outcome
Timeframe: Up to 12 yearsPopulation: Per protocol.
All participants who died independent of the cause to include instantaneous death, death occurring in less than 24 hours from onset of symptoms, not otherwise explained, unattended death and other causes of ill defined morbidity and mortality. Cause of death was coded and classified as either cardiovascular or respiratory.
Outcome measures
| Measure |
Dopamine Agonist (Cohort 1)
n=27812 Participants
Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
|
Levodopa (Cohort 2)
n=14669 Participants
Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase \[COMT\] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
|
Hyperprolactinemia (Cohort 3)
n=15147 Participants
Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
|
Healthy Controls (Cohort 4)
n=29311 Participants
Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
|
|---|---|---|---|---|
|
Number of Participants With All-Cause Mortality Per 10,000 Participant-Years of Follow-Up
|
170 Participants/10,000 Participant-Years
|
803 Participants/10,000 Participant-Years
|
NA Participants/10,000 Participant-Years
Due to limited number of exposed cases in hyperprolactinemia cohort, no additional analyses beyond exploration of cabergoline and other single products (current, past) vs non-use, and where possible, dose/duration effect could be performed.
|
719 Participants/10,000 Participant-Years
|
Adverse Events
Dopamine Agonist (Cohort 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Levodopa (Cohort 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hyperprolactinemia (Cohort 3)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls (Cohort 4)
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
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