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An Observational Study and Meta-analysis

Jean-Christophe Corvol, MD, PhD; Jean-Baptiste Anzouan-Kacou, MD; Elodie Fauveau, MD; Anne-Marie Bonnet, MD; Bénédicte Lebrun-Vignes, MD; Camille Girault, PharmD; Yves Agid, MD, PhD; Philippe Lechat, MD, PhD; Richard Isnard, MD; Lucette Lacomblez, MD

Arch Neurol. 2007;64(12):1721-1726.

Objective  To investigate the prevalence and risk factors of heart valve disease in patients having PD treated with pergolide.

Design  Prospective observational study.

Setting  Patients were recruited at the Hôpital de la Pitié-Salpêtrière, Paris, France.

Patients  Ninety-six patients having PD treated with pergolide for longer than 3 months vs 50 control subjects.

Intervention  Standardized echocardiography performed by an investigator blinded to treatment status.

Main Outcome Measure  Moderate to severe regurgitation in at least 1 heart valve.

Results  One hundred thirty-three echocardiograms (86 in the pergolide-treated group and 47 in the control group) were analyzed in the study. Moderate to severe regurgitation was found in 15 patients treated with pergolide (17.4%) and in 2 control subjects (4.3%) (odds ratio [OR], 4.75; 95% confidence interval [CI], 1.02-22.1; P = .03). Moderate to severe regurgitation was associated with the cumulative dose of pergolide (OR, 1.37; 95% CI, 1.04-1.81 per 10-mg/kg increase; P =.03). Including the present study, the meta-analysis comprised 7 trials (394 patients treated with pergolide and 280 controls). The overall OR for moderate to severe regurgitation was 3.1 (95% CI, 1.7-5.6; P < .001) in the pergolide-treated group. Risk differences were correlated with the mean cumulative dose of pergolide (r = 0.90, P < .001).

Data Sources  Using an end point of moderate to severe heart valve regurgitation, we performed a meta-analysis of patients having Parkinson disease (PD) treated with pergolide mesylate vs control subjects by searching PubMed (January 1, 1966, to April 1, 2007) and the Cochrane databases to identify English-language prospective observational studies that reported echocardiographic data.

Conclusion  Heart valve disease is independently associated with the use of pergolide treatment in patients having PD and correlates with its cumulative dose.

Trial Registration  clinicaltrials.gov Identifier: NCT00202657

Author Affiliations: Service de Pharmacologie (Drs Corvol, Agid, Lechat, and Lacomblez), Fédération des Maladies du Système Nerveux (Drs Corvol, Bonnet, Agid, and Lacomblez), Service de Cardiologie (Drs Anzouan-Kacou, Fauveau, and Isnard), Service de Pharmacologie, Centre Régional de Pharmacovigilance (Dr Lebrun-Vignes), and Centre d’Investigation Clinique (Drs Girault and Agid), Université Paris 6–Université Pierre et Marie Curie, Hôpital de la Pitié-Salpêtrière, AP-HP Hopitaux de l’Assistance Publique, Paris, France.