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

Pfizer

Status: Completed

Conditions: Parkinson's Disease; Hyperprolactinemia

Treatments: Other: Retrospective study-

Study type: Observational

Funder types: Industry

Identifiers

NCT01052948

A7231031

Details and patient eligibility

About

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

Enrollment: 86,939 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

86,939 participants in 4 patient groups

Cohort 1

Description:

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

Treatment:

Other: Retrospective study-

Other: Retrospective study-

Other: Retrospective study-

Other: Retrospective study-

Cohort 2

Description:

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

Treatment:

Other: Retrospective study-

Other: Retrospective study-

Other: Retrospective study-

Other: Retrospective study-

Cohort 3

Description:

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

Treatment:

Other: Retrospective study-

Other: Retrospective study-

Other: Retrospective study-

Other: Retrospective study-

Cohort 4

Description:

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

Treatment:

Other: Retrospective study-

Other: Retrospective study-

Other: Retrospective study-

Other: Retrospective study-