The Association Between Dopamine Agonists and Cardiac Valvulopathy, Fibrosis and Other Cardiopulmonary Events

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86939 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-12-31

Brief Summary

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To assess the association between cabergoline and other dopamine agonists (DAs), and symptomatic, diagnosed serious cardiopulmonary disorders, including:

1. Cardiac valve regurgitation
2. Diffuse Pleural/pulmonary thickening and pericardial and retroperitoneal fibrosis
3. Heart failure
4. Total, cardiac and respiratory mortality

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Detailed Description

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Conditions

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Parkinson's Disease Hyperprolactinemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1

All persons who newly start one of the dopamine agonists (DA) after start of eligibility period

Retrospective study-

Intervention Type OTHER

Cohort 2

All persons who started levodopa after start of eligibility period and had not been treated with dopamine agonists anytime prior.

Retrospective study-

Intervention Type OTHER

Cohort 3

All persons with newly diagnosed hyperprolactinemia who had not been treated with dopamine agonists anytime prior.

Retrospective study-

Intervention Type OTHER

Cohort 4

healthy controls from general population matched on age, gender, index date and general practitioner (GP) practice to persons exposed to dopamine agonists

Retrospective study-

Intervention Type OTHER

Interventions

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Retrospective study-

Intervention Type OTHER

Retrospective study-

Intervention Type OTHER

Retrospective study-

Intervention Type OTHER

Retrospective study-

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* At least one year registered with the general practitioner (GP), one year of valid data from the GP, or the date of software conversion (if GP software systems had changed) and meeting criteria for any one of the 4 cohorts as defined.

Exclusion Criteria

* rheumatic heart disease
* congenital heart disease: includes structural defects, congenital arrhythmias, and cardiomyopathies
* dilated cardiomyopathy (congestive cardiomyopathy
* pericardial, pleural, pulmonary or retroperitoneal fibrosis
* endocarditis or myocarditis
* carcinoid syndrome
* intravenous drug abuse
* fibrotic valvular heart disease
* pleural/pulmonary/pericardial/retroperitoneal fibroses
* use of fenfluramine or amiodarone within 3 years prior to date of diagnosis of fibrotic valvular heart disease

Eligible Sex

ALL

Accepts Healthy Volunteers

No