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Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial.
J Pain 2005; 6(4):253-60JP

Abstract

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+Show Affiliations

Neurology Department, St John Medical Center, Tulsa, Oklahoma, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15820913

Citation

Richter, Ralph W., et al. "Relief of Painful Diabetic Peripheral Neuropathy With Pregabalin: a Randomized, Placebo-controlled Trial." The Journal of Pain : Official Journal of the American Pain Society, vol. 6, no. 4, 2005, pp. 253-60.
Richter RW, Portenoy R, Sharma U, et al. Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. J Pain. 2005;6(4):253-60.
Richter, R. W., Portenoy, R., Sharma, U., Lamoreaux, L., Bockbrader, H., & Knapp, L. E. (2005). Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. The Journal of Pain : Official Journal of the American Pain Society, 6(4), pp. 253-60.
Richter RW, et al. Relief of Painful Diabetic Peripheral Neuropathy With Pregabalin: a Randomized, Placebo-controlled Trial. J Pain. 2005;6(4):253-60. PubMed PMID: 15820913.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. AU - Richter,Ralph W, AU - Portenoy,Russell, AU - Sharma,Uma, AU - Lamoreaux,Linda, AU - Bockbrader,Howard, AU - Knapp,Lloyd E, PY - 2004/03/12/received PY - 2004/12/17/revised PY - 2004/12/23/accepted PY - 2005/4/12/pubmed PY - 2005/7/30/medline PY - 2005/4/12/entrez SP - 253 EP - 60 JF - The journal of pain : official journal of the American Pain Society JO - J Pain VL - 6 IS - 4 N2 - 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. SN - 1526-5900 UR - https://www.unboundmedicine.com/medline/citation/15820913/Relief_of_painful_diabetic_peripheral_neuropathy_with_pregabalin:_a_randomized_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1526-5900(05)00003-9 DB - PRIME DP - Unbound Medicine ER -