Indirect comparisons of adverse events and dropout rates in early Parkinson's disease trials of pramipexole, ropinirole, and rasagiline.
The comparative safety profiles of monotherapeutic treatments for Parkinson's disease (PD) can provide valuable therapeutic information. The objective of this study was to perform an indirect comparison of Adverse Events (AEs) and Dropout Rates (DRs) among clinical trials of pramipexole, ropinirole, and rasagiline. Outcomes analyzed included DRs, total AEs, and AE categories: Cognitive (CG), Gastrointestinal (GI), and Sleep/Fatigue (SF). The odds-ratio (OR) and Credible Interval (CrI) of outcomes between products using placebo as common comparator was calculated using indirect meta-analytical methods. AEs incidences for subjects receiving rasagiline were not significantly different from placebo, whereas DRs were significantly lower than for placebo (OR = 0.55; 95% CrI = 0.34-0.88). Patients receiving pramipexole or ropinirole had higher incidence of all AEs and DRs than patients taking rasagiline, except for the nonsignificant incidence of CG for ropinirole vs. rasagiline (1.76; 0.69-4.70). The incidence of GI (2.11; 1.13-4.06) and SF (2.75; 1.42-5.47) was significantly higher for ropinirole than for pramipexole, whereas the incidence of CG was significantly lower for ropinirole than for pramipexole (0.22; 0.07-0.69). Findings suggest that subjects with early PD treated with rasagiline have fewer AEs and DRs than those treated with pramipexole or ropinirole. GI and SF AEs were highest for subjects treated with ropinirole, while individuals treated with pramipexole exhibited the highest incidence of cognitive AEs.
EpiX Analytics, Boulder, CO, USA. fzagmutt@epixanalytics.com
Francisco J
FJ
Zagmutt
Marcy L
ML
Tarrants
D000978:Antiparkinson Agents / Q000009:adverse effects*; D052160:Benzothiazoles; D003072:Cognition Disorders / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology; D003430:Cross-Sectional Studies; D016206:Databases, Bibliographic / Q000706:statistics & numerical data; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D007189:Indans; D007211:Indoles; D016015:Logistic Models; D008297:Male; D010300:Parkinson Disease / Q000150:complications / Q000188:drug therapy*; D010352:Patient Dropouts / Q000706:statistics & numerical data*; D000077487:Pramipexole; D012893:Sleep Wake Disorders / Q000139:chemically induced; D016896:Treatment Outcome
D000978:Antiparkinson Agents; D052160:Benzothiazoles; D007189:Indans; D007211:Indoles; C031967:rasagiline; C046649:ropinirole; D000077487:Pramipexole