安慰剂
医学
临床终点
多发性神经病
不利影响
糖尿病
随机对照试验
内科学
糖尿病神经病变
生活质量(医疗保健)
析因分析
物理疗法
麻醉
内分泌学
护理部
病理
替代医学
作者
Michael Polydefkis,Joseph C. Arezzo,Marshall Nash,Vera Bril,Aziz Shaibani,Robert J. Gordon,Kate Bradshaw,Roderick Junor
摘要
Abstract We examined the efficacy and safety of ranirestat in patients with diabetic sensorimotor polyneuropathy ( DSPN ). Patients (18–75 years) with stable type 1/2 diabetes mellitus and DSPN were eligible for this global, double‐blind, phase II / III study ( ClinicalTrials.gov NCT00927914). Patients (n = 800) were randomized 1 : 1 : 1 to placebo, ranirestat 40 mg/day or 80 mg/day (265 : 264 : 271). Change in peroneal motor nerve conduction velocity ( PMNCV ) from baseline to 24 months was the primary endpoint with a goal improvement vs. placebo ≥1.2 m/s. Other endpoints included symptoms, quality‐of‐life, and safety. Six hundred thirty‐three patients completed the study. The PMNCV difference from placebo was significant at 6, 12, and 18 months in both ranirestat groups, but <1.2 m/s. The mean improvement from baseline at 24 months was +0.49, +0.95, and +0.90 m/s for placebo, ranirestat 40 mg and 80 mg, respectively ( NS ). The treatment difference vs. placebo reached significance when ranirestat groups were combined in a post hoc analysis (+0.44 m/s; p = 0.0237). There was no effect of ranirestat on safety assessments, secondary or exploratory endpoints vs. placebo. Ranirestat was well tolerated and improved PMNCV , but did not achieve any efficacy endpoints. The absence of PMNCV worsening in the placebo group underscores the challenges of DSPN studies in patients with well‐controlled diabetes.
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