Efficacy and safety of pregabalin for treating neuropathic pain associated with diabetic peripheral neuropathy: a 14 week, randomized, double-blind, placebo-controlled trial.

Abstract

AIMS:

To evaluate the efficacy, safety and pharmacokinetics of pregabalin in treating neuropathic pain associated with diabetic peripheral neuropathy in Japanese patients.

METHODS:

A randomized, double-blind, placebo-controlled, multicentre 14 week clinical trial was conducted. Japanese patients with diabetic peripheral neuropathy (n = 317) were randomized to receive placebo or pregabalin at 300 or 600 mg/day. The primary efficacy measure was a change of mean pain score from baseline to end-point from patients' daily pain diaries.

RESULTS:

Significant reductions in pain were observed in patients treated with pregabalin at 300 and 600 mg/day vs. placebo (P < 0.05). Improvements in weekly pain scores were observed as early as week 1 and were sustained throughout the study period (300 and 600 mg/day difference from placebo at study end-point, -0.63 and -0.74, respectively). Pregabalin produced significant improvements in weekly sleep interference scores, the short-form McGill Pain Questionnaire, the Medical Outcomes Study-Sleep Scale, the 36-item Short-Form Health Survey scale, and the Patient and Clinical Global Impression of Change. Patient impressions of numbness, pain and paraesthesia were also significantly improved. Regarding treatment responders, 29.1 and 35.6% of patients treated with 300 and 600 mg/day, respectively, reported ≥ 50% improvement in mean pain scores (vs. 21.5% for placebo). Pregabalin was well tolerated; somnolence (26%), dizziness (24%), peripheral oedema (13%) and weight gain (11%) were the most common adverse events and generally were reported as mild to moderate.

CONCLUSIONS:

Pregabalin was effective in reducing pain and improving sleep disturbances due to pain, and was well tolerated in Japanese patients with painful DPN.

• Authors: J Satoh, S Yagihashi, M Baba, M Suzuki, A Arakawa, T Yoshiyama, S Shoji
• Journal: Diabetic medicine : a journal of the British Diabetic Association (Diabet Med) Vol. 28 Issue 1 Pg. 109-16 (Jan 2011) ISSN: 1464-5491 [Electronic] England
• PMID: 21166852 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2010 The Authors. Diabetic Medicine © 2010 Diabetes UK.

Chemical References

• Analgesics
• Placebos
• Pregabalin
• gamma-Aminobutyric Acid

Topics

• Analgesics (administration & dosage, pharmacokinetics)
• Asian People
• Diabetes Mellitus, Type 1 (complications, drug therapy)
• Diabetes Mellitus, Type 2 (complications, drug therapy, physiopathology)
• Diabetic Neuropathies (drug therapy, physiopathology)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Male
• Middle Aged
• Pain Measurement
• Placebos
• Pregabalin
• Surveys and Questionnaires
• Treatment Outcome
• gamma-Aminobutyric Acid (administration & dosage, analogs & derivatives, pharmacokinetics)