A Comparative Evaluation of Amitriptyline and Duloxetine in Painful Diabetic Neuropathy A randomized, double-blind, cross-over clinical trial

被引:80
|
作者
Kaur, Harjot [2 ]
Hota, Debasish [2 ]
Bhansali, Anil [1 ]
Dutta, Pinaki [1 ]
Bansal, Dipika [3 ]
Chakrabarti, Amitava [2 ]
机构
[1] Postgrad Inst Med Educ & Res, Dept Endocrinol, Chandigarh 160012, India
[2] Postgrad Inst Med Educ & Res, Dept Pharmacol, Chandigarh 160012, India
[3] Natl Inst Pharmaceut Educ & Res, Dept Pharm Practice, Sas Nagar, India
关键词
DIAGNOSE DISTAL POLYNEUROPATHY; PHARMACOLOGICAL MANAGEMENT; COMPARING DULOXETINE; PLACEBO; MULTICENTER; EFFICACY;
D O I
10.2337/dc10-1793
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 bedtime, each for 6 weeks with optional dose uptitration fortnightly. Single-blinded placebo washout 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. Care 34:818-822, 2011
引用
收藏
页码:818 / 822
页数:5
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