[Efficacy of rasagiline in patients with advanced Parkinson's disease with motor fluctuation (azimut study)].
Abstract An open observational 3-month study of efficacy and safety of selective MAO B inhibitor rasagiline (АZIlect) in advanced Parkinson's disease (PD) patients with mоtor fluctuations on the long-term levodopa therapy (the "АZIMUT" study) has been conducted. Forty five non-demented patients with PD (mean age 64,7±8,4 years, mean duration of disease 9,5±4,0 years, mean Hoehn-Yahr stage 3,0±0,4, mean levodopa dose 673,9 mg/d) have been included in the study. All patients received rasagiline at a dose of 1 mg once daily as an adjunct to a stable anti-parkinsonian therapy. Patient's clinical state has been assessed at baseline and after 1 and 3 months of therapy. Forty two (93%) patients have completed the study. At the end of the third month of therapy, the daily off-time was decreased by 1,7 h. The ADL score (off-state) decreased by 22%, and the UPDRS-III score (on-state) decreased by 10%. The Global Clinical Improvement Scale revealed the marked improvement in 12% patients and moderate improvement in 43% patients. The severity of freezing of gait declined by 15%. Moreover, the initial severity of freezing seems to be a predictor of rasagiline clinical efficacy. The clinical effect of rasagiline steadily increased over 3 months. The fair tolerability of the drug and low rate of dyskinesias and other complications were demonstrated. In conclusion, the study has shown that rasagiline effectively reduces the off-time duration as well as the disability in off- and on-time and optimizes levodopa efficacy at the routine clinical practice setting.