Efficacy and tolerability of rasagiline in daily clinical use-A post marketing observational study in patients with Parkinson's disease focusing on non-motor symptoms and QoL

Rasagiline (Azilect (R)) is a highly selective irreversible second generation MAO-B inhibitor indicated for the treatment of idiopathic Parkinson's disease (PD) as monotherapy or as adjunct therapy (with levodopa). The 6-month observational study included 871 patients to investigate the efficacy and tolerability of rasagiline in clinical daily practice focussing on non-motor symptoms and quality of life. Two thirds of the patients received 1 mg rasagiline daily as add-on to their regular PD-medication, the rest as monotherapy. Efficacy criteria were: (1) CURS, (2) PS-23 scale on Parkinson non-motor symptom strength, (3) UPDRS, part IV B, (4) duration of OFF-periods, (5) QoL by PDQ-8, (6) WHO-5 Well-being Index and (7) change of global clinical impression (CGI-I). Significant improvements have been observed in total severity of PD: PS-23 total score declined from 46.4 to 42.2. Health and general well-being measured by PDQ-8 improved significantly from baseline 16.3 to 14.3. Emotional well-being according to WHO-5 improved significantly from 14.4 to 16.4. Positive effects of rasagiline on motor symptoms have been observed: CURS total score improved significantly from 14.8 to 11.4. The proportion of patients without any OFF period increased from 47.1% to 59.1%. Patients reported that OFF periods decreased significantly, most pronounced the morning OFF. Rasagiline has shown to be effective either in monotherapy or in combination with L-Dopa, dopamine agonists or both. AEs were reported by 6.5% of the patients. The treatment with rasagiline in patients with PD resulted in improvements of motor and non-motor symptoms and led to an improved quality of life. (C) 2015 Elsevier GmbH. All rights reserved.