Efficacy and safety of pregabalin for painful diabetic peripheral neuropathy in a population of Chinese patients: A randomized placebo‐controlled trial1: 普瑞巴林在中国痛性糖尿病周围神经病变患者治疗中的疗效及安全性:一项随机安慰剂对照试验. Issue 3 (1st November 2017)

• Record Type: Journal Article
• Authors: Mu, Yiming; Liu, Xiaomin; Li, Quanmin; Chen, Kangning; Liu, Yu; Lv, Xiaofeng; Xu, Xiangjin; Fan, Dongsheng; Shang, Ningxiu; Yang, Ruoyong; Pauer, Lynne; Pan, Changyu
• Is Part Of: Journal of diabetes. Volume 10:Issue 3(2018)
• Page Start: 256
• Page End: 265
• Publication Date: 2017-11-01
• Subjects: Chinese -- diabetic peripheral neuropathy -- pregabalin; 中国 -- 糖尿病周围神经病变 -- 普瑞巴林; Diabetes -- Periodicals; 618.3646005
• DOI: 10.1111/1753-0407.12585
• Languages: English
• ISSNs: 1753-0393

Abstract

Abstract: Background: Limited information exists regarding the efficacy of pregabalin in Chinese patients with painful diabetic peripheral neuropathy (pDPN). Methods: An 11‐week double‐blind placebo‐controlled trial was performed in Chinese pDPN patients randomized (1 : 1) to 300 mg/day pregabalin or placebo. The primary outcome was change from baseline to endpoint in mean pain score (MPS; 0, no pain; 10, worst possible pain; using the mean of the last seven daily pain scores). Secondary outcomes included weekly MPS and responder status (MPS reduced by ≥30% or ≥50% vs baseline). Subgroup analysis assessed patients with severe (≥7) baseline MPS. Adverse events (AEs) were reported. Results: In all, 620 patients were randomized (pregabalin, n = 313; placebo, n = 307). Improvement in MPS with pregabalin versus placebo was not significant ( P = 0.0559). Post hoc sensitivity analyses, excluding one patient/site due to Good Clinical Practice (GCP) non‐compliance, showed pregabalin significantly improved MPS when excluding the patient ( P = 0.0448) or site ( P = 0.0142). Pregabalin significantly improved weekly MPS ( P = 0.0164) and ≥50% responders at endpoint ( P = 0.0384). Improvement in proportion of ≥30% responders, impression of change, pain intensity, and sleep did not differ significantly between the treatment groups. In the severe pDPN subpopulation, pregabalin significantly improved MPS versus placebo ( P = 0.0040). The most commonly reported AE was dizziness (9.6% vs 3.9% with placebo). Conclusions: Pregabalin did not significantly improve the primary measure of pain in the trial. Significant reductions in MPS were observed when excluding the GCP non‐compliant patient/site and in the severe pDPN subpopulation. Pregabalin was well tolerated in Chinese pDPN patients. Abstract : Highlights This is the first study of pregabalin in Chinese pDPN patients, and the findings may inform pDPN treatment in China. Pregabalin significantly improved pain in the subpopulation with severe pDPN. Improvements in additional measures of pain and health status were also significant. Pregabalin did not significantly improve pain associated with painful diabetic peripheral neuropathy (pDPN) compared with placebo in the trial. However, post hoc sensitivity analyses conducted due to good clinical practice (GCP) non‐compliance in one patient showed significant improvement with pregabalin when the non‐compliant patient or associated site was excluded.