Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial.

Abstract

UNLABELLED:

This was a 6-week, randomized, double-blind, multicenter study evaluating the efficacy of pregabalin in the treatment of painful diabetic neuropathy. Two hundred forty-six men and women with painful diabetic neuropathy received pregabalin (150 or 600 mg/day by mouth) or placebo. The primary efficacy variable was mean pain score at the end of treatment. Efficacy results indicate that pregabalin 600 mg/day significantly decreased mean pain score to 4.3 (vs 5.6 for placebo, P = .0002) and increased the proportion of patients who had a > or =50% decrease from baseline pain (39% vs 15% for placebo, P = .002). Pregabalin also significantly reduced sleep interference, past week and present pain intensity, sensory and affective pain scores, and bodily pain and decreased by > or =50% the number of patients describing their pain as gnawing, sickening, fearful, and punishing-cruel. More patients receiving pregabalin 600 mg/day than placebo showed improvement, as rated on the Clinical and Patient Global Impression of Change scales, 73% vs 45% and 85% vs 47%, respectively. Pregabalin 150 mg/day was essentially no different from placebo. Dizziness was the most common side effect. These study results show pregabalin 600 mg/day to be safe and effective in reducing the pain and other associated symptoms of painful diabetic neuropathy.

PERSPECTIVE:

Painful diabetic peripheral neuropathy is a challenging neuropathic pain syndrome. This randomized controlled trial demonstrates that pregabalin, a new drug that interacts with the alpha2-delta protein subunit of the voltage-gated calcium channel, is an efficacious and safe treatment for the pain of this condition.

• Authors: Ralph W Richter, Russell Portenoy, Uma Sharma, Linda Lamoreaux, Howard Bockbrader, Lloyd E Knapp
• Journal: The journal of pain (J Pain) Vol. 6 Issue 4 Pg. 253-60 (Apr 2005) ISSN: 1526-5900 [Print] United States
• PMID: 15820913 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics
• Anticonvulsants
• Calcium Channel Blockers
• Calcium Channels
• Placebos
• Pregabalin
• gamma-Aminobutyric Acid

Topics

• Aged
• Analgesia (methods)
• Analgesics (administration & dosage, adverse effects, blood)
• Anticonvulsants (administration & dosage, adverse effects, blood)
• Calcium Channel Blockers (administration & dosage, adverse effects, blood)
• Calcium Channels (drug effects, metabolism)
• Diabetic Neuropathies (drug therapy, physiopathology, psychology)
• Dizziness (chemically induced)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Pain Measurement (drug effects)
• Placebo Effect
• Placebos
• Pregabalin
• Sleep Initiation and Maintenance Disorders (drug therapy, etiology)
• Stress, Psychological (drug therapy, etiology, psychology)
• Treatment Outcome
• gamma-Aminobutyric Acid (administration & dosage, adverse effects, analogs & derivatives, blood)