127EFFICACY AND SAFETY OF OPICAPONE IN PATIENTS OVER 70 YEARS WITH PARKINSON’S DISEASE AND MOTOR FLUCTUATIONS

Abstract

Objective: Evaluate the efficacy and safety profile of opicapone (OPC) as add‐on to levodopa in patients over 70 years with Parkinson's disease (PD) and motor fluctuations. Background: OPC, a novel once‐daily peripheral COMT inhibitor, has shown to be safe and effective in reducing OFF‐time in PD patients with motor fluctuations. PD mainly affects older subjects and the incidence increases with age, being the second most prevalent neurodegenerative disease among the elderly. Methods: Efficacy and safety data from two multicentre, double‐blind, randomised, placebo‐ and active‐controlled studies (BIPARK I and II) were pooled and evaluated by age (<70 and>70 years). Outcome efficacy measures included the change from baseline to endpoint in absolute OFFtime and the OFF‐ and ON‐time responder rates (> 1 hour). Safety was evaluated by analysis of reported adverse events (AEs). Results: A total of 221 patients>70 years were analysed (N=69, 66 and 86 for placebo, 25mg‐ and 50mg‐OPC, respectively). The mean daily OFF‐time was reduced by ‐1.41 h for placebo, 1.77 h (p=0.4086) for 25mg‐OPC and ‐2.26 h (p=0.0384) for 50mg‐OPC. Consistently, higher proportions of patients receiving either 25mg‐ or 50mg‐OPC achieved the OFF‐ and ON‐time responders endpoint (p<0.05 for 50mg‐OPC). AEs occurring more frequently in the elderly (adjusted for placebo) included hallucinations (4.6% vs. 0.1%), visual hallucinations (3.8% vs. 0.1%) and weight decreased (4.6% vs. 1.1%). The incidence of serious AEs was lower in OPC treated patients than placebo. Conclusions: OPC is effective and well tolerated by PD patients over 70 years old.