A recent study showed that pregabalin improved MPS in painful diabetic peripheral neuropathy. Pregabalin did not significantly improved the primary measure of pain. Not much information is available which can define the efficacy of pregabalin in Chinese patients with diabetic peripheral neuropathy (pDPN). Therefore the current study is done to determine the efficacy and safety of  Pregabalin for painful diabetic peripheral neuropathy in a population of Chinese patients. The study designed as a double-blind, placebo-controlled trial for 11-week, in Chinese pDPN patients. They randomized (1:1) to pregabalin 300 mg/day or placebo. Change done in the primary efficacy endpoint from baseline in mean daily pain score (0 = no pain;10 = worst possible pain). Secondary efficacy endpoints comprised of overall weekly mean pain score, responder status, the impression of change, pain intensity, and sleep. Subgroup analysis estimated the change in pain in patients with severe (≥7) baseline pain. Adverse events (AEs) were reported.

In the study around 620 patients were randomized and treated (313, pregabalin; 307, placebo). No significant improvement appeared in mean pain score with pregabalin versus placebo (mean treatment difference -0.28;P=0.0559). Post-hoc sensitivity analyses, excluding one patient due to GCP non-compliance, showed pregabalin significantly improved the mean pain score when excluding the patient (-0.30;P=0.0448) or the associated site (-0.38;P=0.0142). Significantly improvement with pregabalin in overall weekly mean pain score (P=0.0164) and ≥50% responders at endpoint observed (P=0.0384). Improvement in ≥30% responders, the impression of change, pain intensity, and sleep was not significant. In the severe subpopulation, pregabalin significantly improved the mean pain score versus placebo (-0.79; P=0.0040). Dizziness, most commonly reported AE (9.6% vs 3.9% with placebo).