A Prospective, Multicenter, 2-Year Echocardiographic Study on Valvular Heart Disease in Parkinson's Disease Patients Taking Rotigotine and Other non-Ergot Dopamine Agonists

Abstract

Objectives: We explored the possible risk of valvular heart disease (VHD) in Parkinson's disease (PD) patients taking rotigotine compared to other non-ergot dopamine agonists (DA) as requested by the EMA (European Medicines Agency) in terms of assessing the longterm safety associated with the cumulative dose of rotigotine. Methods:We performed a prospective, multicenter, open-label, 2-year echocardiographic study in PD patients taking rotigotine or other non-ergot DA (piribedil, pramipexole, ropinirole). Valvular pathology was assessed by transthoracic echocardiographic examinations according to American Society of Echocardiography recommendations and a scoring system for restrictive VHD at 1-month, 12-months and 24-months follow-up examination. Routine neurological and physical examinations with special attention toward clinical symptoms of heart failure were performed after 1, 6, 12, 18 and 24 months.Results: 102 out of 107 screened patients were enrolled into the study. Due to drop-outs along the 2-year followup, 66 patients (28 rotigotine, 38 other non-ergot DAs [3 piribedil, 20 pramipexole, 15 ropinirole]) completed the 12-months visit and 53 patients (23 rotigotine, 30 other non-ergot DAs [3 piribedil, 16 pramipexole, 11 ropinirole]) completed the 24-months visit. No patient showed clinical symptoms of heart failure or echocardiographic evidence of restrictive VHD during the 2-year period. Analyses of valve regurgitation (VR) revealed no case of severe or moderate VR in the rotigotine group. Only one patient taking pramipexole showed moderate VR at 1-month and 12-months follow-up visit decreasing to mild degree at 24-months follow-up.Conclusions: This is the first prospective study assessing the possible risk of VHD in patients taking rotigotine. We did not find valvular pathology suggestive for restrictive VHD or increased risk of cardiac VR in PD patients receiving rotigotine or other non-ergot DAs. Future studies are needed to explore the clinical relevance and the relationship between non-ergot DAs and heart failure including effects of cumulative dose or comedication with other antiparkinsonian drugs.