Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial

• Published in: Neurology Vol. 63; no. 11; p. 2104
• Main Authors: Lesser, H, Sharma, U, LaMoreaux, L, Poole, R M
• Format: Journal Article
• Language: English
• Published: United States 14.12.2004
• Subjects: Adult; Aged; Aged, 80 and over; Analgesics, Non-Narcotic - administration & dosage; Analgesics, Non-Narcotic - adverse effects; Analgesics, Non-Narcotic - therapeutic use; Diabetic Neuropathies - drug therapy; Double-Blind Method; Excitatory Amino Acid Antagonists - administration & dosage; Excitatory Amino Acid Antagonists - therapeutic use; Female; gamma-Aminobutyric Acid - administration & dosage; gamma-Aminobutyric Acid - adverse effects; gamma-Aminobutyric Acid - analogs & derivatives; gamma-Aminobutyric Acid - therapeutic use; Humans; Male; Middle Aged; Neuralgia - drug therapy; Neuralgia - etiology; Pain Measurement; Pregabalin; Sleep Disorders, Intrinsic - drug therapy; Sleep Disorders, Intrinsic - etiology
• ISSN: 1526-632X
• DOI: 10.1212/01.WNL.0000145767.36287.A1

Pregabalin, an alpha2-delta ligand with analgesic, anxiolytic, and anticonvulsant activity, has been evaluated for treatment of neuropathic pain. The authors assessed the efficacy and tolerability of pregabalin (75, 300, 600 mg/day) vs placebo in patients with diabetic peripheral neuropathy (DPN). Patients with a 1- to 5-year history of DPN and average weekly pain score of > or =4 on an 11-point numeric pain-rating scale were enrolled in a 5-week, double-blind, multicenter, placebo-controlled study. Patients (n = 338) were randomized to receive one of three doses of pregabalin or placebo TID. Pregabalin 600 mg/day was titrated over 6 days; lower doses were initiated on day 1. Patients in the 300- and 600-mg/day pregabalin groups showed improvements in endpoint mean pain score (primary efficacy measure) vs placebo (p = 0.0001). Improvements were also seen in weekly pain score, sleep interference score, patient global impression of change, clinical global impression of change, SF-McGill Pain Questionnaire, and multiple domains of the SF-36 Health Survey. Improvements in pain and sleep were seen as early as week 1 and were sustained throughout the 5 weeks. Responders (patients with > or =50% reduction in pain compared to baseline) were 46% (300 mg/day), 48% (600 mg/day), and 18% (placebo). Pregabalin was well tolerated with a low discontinuation rate. The most common adverse events were dizziness and somnolence. In patients with diabetic peripheral neuropathy, pregabalin demonstrated early and sustained improvement in pain and a beneficial effect on sleep, which were confirmed by positive patient global impression. Pregabalin was well tolerated at all doses.