Poewe Werner, Hauser Robert A, Lang Anthony
Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.
Mov Disord. 2015 Apr;30(4):589-92. doi: 10.1002/mds.26124. Epub 2014 Dec 27.
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.
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.
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).
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.
MDS-UPDRS量表第1部分(日常生活体验的非运动方面;nM-EDL)的草稿版本被用作ADAGIO研究的次要结果,该研究评估了雷沙吉兰对早期帕金森病(PD)患者的疗效。
该分析纳入了1150例未接受治疗的PD患者,这些患者在ADAGIO研究的安慰剂对照阶段被随机分配至安慰剂组或雷沙吉兰1或2mg/天组,为期36周,且在基线和第36周进行了nM-EDL评估。
在研究的9个月安慰剂对照阶段,仅安慰剂组的nM-EDL评分较基线显著恶化(0.34±0.10单位;P<0.001)。与安慰剂组(n = 583)相比,1mg/天雷沙吉兰组(n = 280)的恶化程度显著更低(治疗效果:-0.33单位;P<0.05),而2mg/天雷沙吉兰组(n = 287)的治疗效果无统计学意义(-0.25±0.17单位;P = 0.131)。
nM-EDL子量表似乎对极早期PD的变化敏感,与安慰剂相比,1mg/天雷沙吉兰治疗使日常生活的非运动体验下降显著更少。鉴于评分变化的数值较小,这种效应的临床意义仍不明确。