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From the University of Rochester School of Medicine & Dentistry (Dr. Lesser), Rochester, NY; Pfizer Global Research and Development (Drs. Sharma and LaMoreaux), Ann Arbor, MI; and Pfizer Global Research and Development (Dr. Poole), New London, CT.
Address correspondence and reprint requests to Dr. Harold Lesser, 1415 Portland Ave, Suite 480, Rochester, NY 14621; e-mail: Harold.Lesser{at}viahealth.org
Objective: 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).
Methods: Patients with a 1- to 5-year history of DPN and average weekly pain score of 
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.
Results: 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 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.
Conclusions: 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.
Received December 24, 2003. Accepted in final form July 26, 2004.
Drs. Sharma, LaMoreaux, and Poole own stock in Pfizer Global Research and Development. Dr. Poole owns stock in excess of $10,000.
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