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


CONCLUSIONS
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.
Richter
Ralph W
RW
Neurology Department, St John Medical Center, Tulsa, Oklahoma, USA.
Portenoy
Russell
R
Sharma
Uma
U
Lamoreaux
Linda
L
Bockbrader
Howard
H
Knapp
Lloyd E
LE
D000368:Aged; D000698:Analgesia / Q000379:methods*; D000700:Analgesics / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D000927:Anticonvulsants / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood; D015220:Calcium Channels / Q000187:drug effects / Q000378:metabolism; D003929:Diabetic Neuropathies / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D004244:Dizziness / Q000139:chemically induced; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000187:drug effects; D015990:Placebo Effect; D010919:Placebos; D000069583:Pregabalin; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy / Q000209:etiology; D013315:Stress, Psychological / Q000188:drug therapy / Q000209:etiology / Q000523:psychology; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood
D000700:Analgesics; D000927:Anticonvulsants; D002121:Calcium Channel Blockers; D015220:Calcium Channels; D010919:Placebos; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid