François Montastruc1,2,3,4,5, Florence Moulis1,2, Mélanie Araujo1,2, Leila Chebane1,2, Olivier Rascol1,4,5,6, Jean-Louis Montastruc7,8,9,10,11. 1. Laboratoire de Pharmacologie Médicale et Clinique de la Faculté de Médecine et du Centre Hospitalier Universitaire de Toulouse, Toulouse, France. 2. Centre Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Pharmacopôle Midi-Pyrénées, Centre Hospitalier Universitaire de Toulouse, Toulouse, France. 3. INSERM UMR 1027, Faculté de Médecine, Université de Toulouse, Toulouse, France. 4. CIC INSERM 1436, Université et Centre Hospitalier Universitaire de Toulouse, Toulouse, France. 5. NeuroToul Centre of Excellence in Neurodegeneration, Université et Centre Hospitalier Universitaire deToulouse, Toulouse, France. 6. INSERM UMR 825, Université de Toulouse, Toulouse, France. 7. Laboratoire de Pharmacologie Médicale et Clinique de la Faculté de Médecine et du Centre Hospitalier Universitaire de Toulouse, Toulouse, France. jean-louis.montastruc@univ-tlse3.fr. 8. Centre Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Pharmacopôle Midi-Pyrénées, Centre Hospitalier Universitaire de Toulouse, Toulouse, France. jean-louis.montastruc@univ-tlse3.fr. 9. INSERM UMR 1027, Faculté de Médecine, Université de Toulouse, Toulouse, France. jean-louis.montastruc@univ-tlse3.fr. 10. CIC INSERM 1436, Université et Centre Hospitalier Universitaire de Toulouse, Toulouse, France. jean-louis.montastruc@univ-tlse3.fr. 11. NeuroToul Centre of Excellence in Neurodegeneration, Université et Centre Hospitalier Universitaire deToulouse, Toulouse, France. jean-louis.montastruc@univ-tlse3.fr.
Abstract
PURPOSE: Some studies have suggested a potential risk of heart failure in patients with Parkinson's disease receiving dopamine (DA) agonists. However, the results are conflicting. We used VigiBase®, the World Health Organization (WHO) Global Individual Case Safety Reports (ICSRs) database, to investigate a potential signal strengthening of heart failure with DA agonists in Parkinsonian patients older than 45 years. METHODS: A case/non-case (disproportionality) analysis was performed in Vigibase® using ICSRs registered between 1978 and May 2016. The signal of disproportionality was calculated using reporting odds ratios (ROR). In our study, 154 ICSRs of heart failure occurring in 154 Parkinsonian patients (mean age 69.6 years, 51 % women) treated with DA agonists were included. RESULTS AND CONCLUSION: There was a significant signal between occurrence of heart failure and exposure to pergolide or cabergoline in particular and ergot derivatives in general. In contrast, none signal was found for rotigotine, pramipexole, apomorphine, or ropinirole in particular and non-ergot derivatives in general. The present study underlines the importance to prescribe as DA agonists in Parkinsonian patients only non-ergot derivatives, excluding ergot drugs.
PURPOSE: Some studies have suggested a potential risk of heart failure in patients with Parkinson's disease receiving dopamine (DA) agonists. However, the results are conflicting. We used VigiBase®, the World Health Organization (WHO) Global Individual Case Safety Reports (ICSRs) database, to investigate a potential signal strengthening of heart failure with DA agonists in Parkinsonianpatients older than 45 years. METHODS: A case/non-case (disproportionality) analysis was performed in Vigibase® using ICSRs registered between 1978 and May 2016. The signal of disproportionality was calculated using reporting odds ratios (ROR). In our study, 154 ICSRs of heart failure occurring in 154 Parkinsonianpatients (mean age 69.6 years, 51 % women) treated with DA agonists were included. RESULTS AND CONCLUSION: There was a significant signal between occurrence of heart failure and exposure to pergolide or cabergoline in particular and ergot derivatives in general. In contrast, none signal was found for rotigotine, pramipexole, apomorphine, or ropinirole in particular and non-ergot derivatives in general. The present study underlines the importance to prescribe as DA agonists in Parkinsonianpatients only non-ergot derivatives, excluding ergot drugs.
Authors: M Mostafa Mokhles; Gianluca Trifirò; Jeanne P Dieleman; Mendel D Haag; Eva M van Soest; Katia M C Verhamme; Giampiero Mazzaglia; Ron Herings; Cynthia de Luise; Douglas Ross; Guy Brusselle; Annamaria Colao; Willem Haverkamp; Rene Schade; Guy van Camp; Renzo Zanettini; Miriam C J M Sturkenboom Journal: Pharmacol Res Date: 2011-11-23 Impact factor: 7.658
Authors: Santiago Perez-Lloret; María Verónica Rey; James Crispo; Daniel Krewski; Marise Lapeyre-Mestre; Jean-Louis Montastruc; Olivier Rascol Journal: Expert Opin Drug Saf Date: 2014-03 Impact factor: 4.250