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Drug Safety
Published in: Drug Safety 2/2012

01-02-2012 | Original Research Article

Risk of Cardiac Valve Regurgitation with Dopamine Agonist use in Parkinson’s Disease and Hyperprolactinaemia

A Multi-Country, Nested Case-Control Study

Authors: Dr Gianluca Trifirò, M. Mostafa Mokhles, Jeanne P. Dieleman, Eva M. van Soest, Katia Verhamme, Giampiero Mazzaglia, Ron Herings, Cynthia de Luise, Douglas Ross, Guy Brusselle, Annamaria Colao, Wilhelm Haverkamp, Rene chade, Guy van Camp, Renzo Zanettini, Miriam C. Sturkenboom

Published in: Drug Safety | Issue 2/2012

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Abstract

Background: There is growing evidence that ergot dopamine agonists may induce cardiac valve regurgitation (CVR) in persons with Parkinson’s disease. It is unclear whether the CVR risk is increased with ergot-dopamine agonist use in persons with hyperprolactinaemia, in whom the dose is much lower.
Objective: The aim of the study was to explore the association between different dopamine agonists and CVR in patients with Parkinson’s disease or hyperprolactinaemia.
Design: Nested case-control studies conducted separately in cohorts of Parkinson’s disease and hyperprolactinaemia patients. Cases were patients who developed newly diagnosed CVR. Controls were CVR-free patients from the same cohorts and were matched to cases by age, sex, database and calendar year.
Setting and Patients: Study patients were identified from over 4.5 million persons in The Health Improvement Network (THIN; UK), Health Search (Italy), and Integrated Primary Care Information (IPCI; the Netherlands) general practice databases in the years 1996–2007. The Parkinson’s disease cohort included new users of dopamine agonists or levodopa, while the hyperprolactinaemia cohort included new users or non-users of dopamine agonists.
Main Outcome Measure: Risk of newly diagnosed CVR with dopamine agonist use compared with levodopa use in the Parkinson’s disease cohort, and dopamine agonist-naïve patients in the hyperprolactinaemia cohort.
Results: In the Parkinson’s disease cohort (7893 dopamine agonist users, 11 766 levodopa users), 85 incident CVR cases were identified. Increased CVR risk was observed for ergot dopamine agonists (adjusted OR [ORadj] 3.82; 95% CI 2.14, 6.81), but not for non-ergot dopamine agonists (ORadj 1.20; 95% CI 0.63, 2.29).
In the hyperprolactinaemia cohort (6740 dopamine agonist users and 14299 dopamine agonist-naïve patients), 37 CVR cases were identified during a mean follow-up of 4.5 years and 3.5 years for new users and non-users of dopamine agonists, respectively. However, no association with ever use of ergot dopamine agonists was observed (ORadj 0.47; 95% CI 0.20,1.19).
Conclusion: Ergot-derived dopamine agonists are associated with an increased risk of CVR in Parkinson’s disease but not in hyperprolactinaemia patients.
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Metadata
Title
Risk of Cardiac Valve Regurgitation with Dopamine Agonist use in Parkinson’s Disease and Hyperprolactinaemia
A Multi-Country, Nested Case-Control Study
Authors
Dr Gianluca Trifirò
M. Mostafa Mokhles
Jeanne P. Dieleman
Eva M. van Soest
Katia Verhamme
Giampiero Mazzaglia
Ron Herings
Cynthia de Luise
Douglas Ross
Guy Brusselle
Annamaria Colao
Wilhelm Haverkamp
Rene chade
Guy van Camp
Renzo Zanettini
Miriam C. Sturkenboom
Publication date
01-02-2012
Publisher
Springer International Publishing
Published in
Drug Safety / Issue 2/2012
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI
https://doi.org/10.2165/11594940-000000000-00000

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