TITLE

A Comparative Evaluation of Amitriptyline and Duloxetine in Painful Diabetic Neuropathy

AUTHOR(S)
KAUR, HARJOT; HOTA, DEBASISH; BHANSALI, ANIL; DUTTA, PINAKI; BANSAL, DIPIKA; CHAKRABARTI, AMITAVA
PUB. DATE
April 2011
SOURCE
Diabetes Care;Apr2011, Vol. 34 Issue 4, p818
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
OBJECTIVE--To compare the efficacy and safety of duloxetine and amitriptyline in painful diabetic neuropathy (PDN). RESEARCH DESIGN AND METHODS--In this randomized, double-blind, cross-over, active-control trial, 58 patients received amitriptyline and duloxetine orally once daily at bed-time, each for 6 weeks with optional dose uptitration fortnightly. Single-blinded placebo wash-out was given for 2 weeks between the two treatments and a single-blinded placebo run-out phase of 4 weeks was given at the end of the treatment period. Pain relief was measured by the patient's global assessment of efficacy, using a visual analog scale (0-100) as a primary end point, and overall improvement and adverse events were assessed as secondary outcome measures. Median pain score reductions of >50%, 25-50%, and <25% were considered good, moderate, and mild responses, respectively. RESULTS--There was a significant improvement in pain with both treatments compared with their baseline values (P < 0.001 for both). Good, moderate, and mild pain relief was achieved in 55, 24, and 15% of patients, respectively, on amitriptyline and 59, 21, and 9% of patients, respectively, on duloxetine. There were no significant differences in various other outcome measures between the groups. Of the reported adverse events, dry, mouth was significantly more common with amitriptyline than duloxetine (55 vs. 24%; P < 0.01). Although, numerically, more patients preferred duloxetine, overall this was not statistically significant (48 vs. 36%; P = 0.18). CONCLUSIONS--Both duloxetine and amitriptyline demonstrated similar efficacy in PDN. A large, multicentric clinical trial in other populations could possibly demonstrate the superiority of either drug.
ACCESSION #
60705061

 

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