背景:在中国尚无有效的治疗糖尿病性周围神经性疼痛(DPNP)的药物。包括米罗加巴林在内的加巴喷丁类药物显示出了希望,尽管中国患者的数据很少。
方法:此阶段3,多中心,随机化,双盲,安慰剂对照试验研究了米罗加巴林在中国治疗DPNP的疗效和安全性.在第一周内每天两次给予5mg米加巴林,并每天两次上调至15mg,总持续时间为14周。主要疗效终点是第14周时每周平均每日疼痛评分(ADPS)相对于基线的变化;次要终点包括ADPS应答者率,简短的McGill疼痛问卷视觉模拟量表评分,患者整体变化印象(PGIC),平均每日睡眠干扰评分(ADSIS),EuroQol5维5级(EQ-5D-5L),以及因治疗引起的不良事件(TEAE)的发生率。
结果:在393例患者中(米罗加巴林,n=196;安慰剂n=197),平均年龄为58.2岁(米罗加巴林,58.7年;安慰剂,57.7岁)和54.2%为男性(米罗加巴林,56.1%;安慰剂,52.3%)。米罗加巴林在每周的ADPS与基线中引起更大的变化第14周的安慰剂:最小二乘平均差(95%置信区间)与安慰剂-0.39(-0.74,-0.04),p=0.0301。PGIC,ADSIS,和EQ-5D-5L数据反映了接受米罗加巴林的患者与接受米罗加巴林治疗的患者的改善明显更好安慰剂。米罗加巴林组和安慰剂组TEAE的发生率分别为75.0%和75.1%,分别。大多数TEAE为轻度或中度,导致治疗中止的TEAE发生率在米罗加巴林组为2.6%,在安慰剂组为1.5%.
结论:尽管由于安慰剂效应,米罗加巴林的效应大小减小了,米罗加林是中国DPNP患者安全有效的治疗选择。
背景:ClinicalTrials.gov标识符,NCT04094662。
BACKGROUND: There is no approved effective drug for diabetic peripheral neuropathic pain (DPNP) in China. Gabapentinoids including
mirogabalin have shown promise, although data in Chinese patients are scarce.
METHODS: This phase 3, multicenter, randomized, double-blind, placebo-controlled trial investigated the efficacy and safety of mirogabalin for treating DPNP in China.
Mirogabalin was administered at 5 mg twice daily for the first week and uptitrated to 15 mg twice daily for a total duration of 14 weeks. The primary efficacy endpoint was the change from baseline in weekly average daily pain score (ADPS) at week 14; secondary endpoints included the ADPS responder rate, Short-Form McGill Pain Questionnaire visual analogue scale score, patient global impression of change (PGIC), average daily sleep interference score (ADSIS), EuroQol 5-dimensions 5-levels (EQ-5D-5L), and incidence of treatment-emergent adverse events (TEAEs).
RESULTS: Of 393 patients (mirogabalin, n = 196; placebo n = 197), the mean age was 58.2 years (
mirogabalin, 58.7 years; placebo, 57.7 years) and 54.2% were male (
mirogabalin, 56.1%; placebo, 52.3%). Mirogabalin elicited a greater change from baseline in the weekly ADPS vs. placebo at week 14: least-squares mean difference (95% confidence interval) vs. placebo - 0.39 (- 0.74, - 0.04), p = 0.0301. PGIC, ADSIS, and EQ-5D-5L data reflected significantly better improvements for patients receiving mirogabalin vs. placebo. The incidence of TEAEs was 75.0% and 75.1% in the
mirogabalin and placebo groups, respectively. Most TEAEs were mild or moderate, and the incidence of TEAEs leading to treatment discontinuation was 2.6% in the mirogabalin group and 1.5% in the placebo group.
CONCLUSIONS: Although the effect size of mirogabalin was reduced due to the placebo effect,
mirogabalin is a safe and effective treatment option for Chinese patients with DPNP.
BACKGROUND: ClinicalTrials.gov identifier, NCT04094662.