Adverse drug reactions to dopaminergic agonists: a study in the French Pharmacovigilance Database

SANTIAGO PEREZ-LLORET; EMMANUELLE BONDON-GUITTON; OLIVIER RASCOL

Buenos Aires, Argentina

Congreso; Congreso Internacional de Movimientos Anormales; 2010

Objective: To compare the frequency of ADR reports between the different DA.Background: Dopamine agonists (DA) are mainly used in Parkinson´s Disease, (apomorphine, bromocriptine,lisuride, pergolide, piribedil, pramipexole, ropinirole) but also in hyperprolactinemia (bromocriptine, cabergoline,lisuride, quinagolide) or Restless Leg Syndrome (pramipexole or ropinirole). Differences in pharmacokinetics and inaffinities to dopamine alpha or serotonin receptors, could suggest possible differences in their adverse drugreactions (ADRs) profile.Methods: We used the French Pharmacovigilance Database to select ADRs reports from 1st January 1984 to 31stDecember 2008, in which at least one DA was suspected. The numbers of specific ADRs were compared betweenthe different DA. Odds Ratios (OR) with their 99.3% confidence interval (to compensate for alpha-error inflation)Results: 2189 suspected reports were analyzed (bromocriptine: 39%, piribedil: 28%, ropinirole: 13%, other:20%). Diurnal somnolence was less frequently reported with all DA as compared to ropinirole (6% vs 23%,p<0.001). Impulse Control Disorders were more frequently reported with pramipexole [OR=6.20 (1.61-23.86)].Although a significant difference could be noticed among DA in the frequency of confusion or disorientation(p<0.001), nausea and vomiting (p<0.05) or edemas (p<0.001), no single comparison yielded significantdifferences with ropinirole. No difference among DA was observed in the frequency of hallucination or arterialhypotension ADR reports (p=0.3 and p=0.1 respectively). Cardiac valvulopathy was significantly more frequentlyreported with pergolide as compared to ropinirole (45% vs 5%, p<0.001).Conclusions: Our data show significant differences in the kind of ADR reported for each DA. Pergolide appeared asthe leading cause of cardiac disorders, while ropinirole was associated with the highest frequency of diurnalsomnolence reports and pramipexole with more frequent neuropsychiatric ADR reports, including impulse controldisorders.