Safinamide potentiates the effects of DA-agonists in early stage Parkinson's disease (PD) patients.

Aim: To compare in early stage PD patients on single DA-agonists the efficacy and safety of safinamide against that of a placebo. Background: Safinamide, a novel anti-PD agent, has both selective and reversible MAO-B and glutamate release inhibition and has shown potential efficacy in increasing the effect of DA-agonists. This may be beneficial in early PD as DA-agonist monotherapy efficacy tend to lessen after 2-3 years. Methods: Either safinamide (Low dose: 50-100 mg/day or High dose: 150-200 mg/day) or placebo were administered to 270 non-fluctuating PD patients (<5 yr duration) who were on a single DA-agonist in a double-blind, placebo-controlled, international, 24-week, Phase III study. Regular efficacy and safety evaluations were performed. Results: Patients were on ropinirole (45%), pramipexole (20%), cabergoline (7%) and other DA-agonists (28%). From the baseline to endpoint in the ITT analysis those on DA-agonist and safinamide showed more efficacy than those on DA-agonists alone (P<0.05) [Low dose safinamide: UPDRS III: -3.6 + 7.1 vs -6.0 + 7.2 and UPDRS II: -1.2 + 3.5 vs -2.2 + 3.8]. At endpoint more "responders" were seen in both safinamide groups assessed either by > 30% improvement in UPDRS III (High dose: 54.3%; Low dose: 50.6%; Placebo: 34.6%) or a score of 1,2 or 3 on CGI-Change (High dose: 65.8%; Low dose: 67.9%; Placebo: 49.4%). Those on safinamide also showed improved cognitive function. Quality of life also showed a trend towards improvement. Safinamide was generally well tolerated. Conclusions: Safinamide, in early stage PD patients, potentiated the effect of a single DA-agonist with improvement in both motor symptoms and ADL. Improved cognition with safinamide was also noted. [ABSTRACT FROM AUTHOR]