Movement disorders : official journal of the Movement Disorder Society · 2014
Effects of rasagiline on the progression of nonmotor scores of the MDS-UPDRS.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Poewe Werner, Hauser Robert A, Lang Anthony, ADAGIO Investigators
Аннотация
BACKGROUND: A draft version of part 1 (Non-Motor Aspects of Experiences of Daily Living; nM-EDL) of the MDS-UPDRS scale was employed as a secondary outcome in the ADAGIO study, which assessed the effect of rasagiline in early Parkinson's disease (PD) patients.
METHODS: This analysis includes 1,150 untreated PD patients randomized to placebo or rasagiline 1 or 2 mg/day for 36 weeks in the placebo-controlled phase of ADAGIO who had draft-nM-EDL assessments at baseline and week 36.
RESULTS: Over the 9-month placebo-controlled phase of the study, nM-EDL scores significantly deteriorated from baseline in the placebo group only (0.34 ± 0.10 units; P < 0.001). Compared to the placebo group (n = 583), there was significantly less deterioration in the 1-mg/day rasagiline group (n = 280; treatment effect: -0.33 units; P < 0.05), whereas the treatment effect in the 2-mg/day rasagiline group (n = 287) was not statistically significant (-0.25 ± 0.17 units; P = 0.131).
CONCLUSIONS: The nM-EDL subscale appears sensitive to change in very early PD, and treatment with rasagiline 1 mg/day was associated with significantly less decline in nonmotor experiences of daily living versus placebo. Given that score changes were numerically small, the clinical implications of this effect remain unclear.
METHODS: This analysis includes 1,150 untreated PD patients randomized to placebo or rasagiline 1 or 2 mg/day for 36 weeks in the placebo-controlled phase of ADAGIO who had draft-nM-EDL assessments at baseline and week 36.
RESULTS: Over the 9-month placebo-controlled phase of the study, nM-EDL scores significantly deteriorated from baseline in the placebo group only (0.34 ± 0.10 units; P < 0.001). Compared to the placebo group (n = 583), there was significantly less deterioration in the 1-mg/day rasagiline group (n = 280; treatment effect: -0.33 units; P < 0.05), whereas the treatment effect in the 2-mg/day rasagiline group (n = 287) was not statistically significant (-0.25 ± 0.17 units; P = 0.131).
CONCLUSIONS: The nM-EDL subscale appears sensitive to change in very early PD, and treatment with rasagiline 1 mg/day was associated with significantly less decline in nonmotor experiences of daily living versus placebo. Given that score changes were numerically small, the clinical implications of this effect remain unclear.