Open AccessEfficacy and safety of pregabalin for painful diabetic peripheral neuropathy in a population of Chinese patients: A randomized placebo‐controlled trial
Author(s) -
Mu Yiming,
Liu Xiaomin,
Li Quanmin,
Chen Kangning,
Liu Yu,
Lv Xiaofeng,
Xu Xiangjin,
Fan Dongsheng,
Shang Ningxiu,
Yang Ruoyong,
Pauer Lynne,
Pan Changyu
Publication year - 2018
Publication title -
journal of diabetes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.949
H-Index - 43
eISSN - 1753-0407
pISSN - 1753-0393
DOI - 10.1111/1753-0407.12585
Subject(s) - pregabalin , medicine , placebo , clinical endpoint , randomized controlled trial , adverse effect , peripheral neuropathy , anesthesia , post hoc analysis , population , diabetes mellitus , alternative medicine , environmental health , pathology , endocrinology
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.