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学科主题: 临床医学
题名:
Treatment of patients with diabetic peripheral neuropathic pain in China: a double-blind randomised trial of duloxetine vs. placebo
作者: Gao, Y.1; Guo, X.1; Han, P.2; Li, Q.3; Yang, G.4; Qu, S.5; Yue, L.6; Wang, C. -N.6; Skljarevski, V.7; Duenas, H.8; Raskin, J.9; Gu, L.6
刊名: INTERNATIONAL JOURNAL OF CLINICAL PRACTICE
发表日期: 2015-09-01
DOI: 10.1111/ijcp.12641
卷: 69, 期:9, 页:957-966
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Medicine, General & Internal ; Pharmacology & Pharmacy
研究领域[WOS]: General & Internal Medicine ; Pharmacology & Pharmacy
关键词[WOS]: ENTERIC-COATED TABLETS ; LONG-TERM MANAGEMENT ; OPEN-LABEL ; COMPARING DULOXETINE ; CLINICAL IMPORTANCE ; ROUTINE CARE ; PHARMACOKINETICS ; VOLUNTEERS ; EXTENSION ; SYMPTOMS
英文摘要:

BackgroundDuloxetine has been approved in the United States, European Union and some Asian countries for the treatment of diabetic peripheral neuropathic pain (DPNP). We assessed the efficacy and safety of duloxetine (60mg once daily) compared with placebo in Chinese patients suffering from DPNP.

MethodsThis was a phase 3, multicenter, randomised, double-blind, parallel, placebo-controlled, 12-week trial of the treatment of DPNP with duloxetine. Subjects were male and female outpatients 18years of age with DPNP, as assessed by the Michigan Neuropathy Screening Instrument, and had a rating of 4 on the Brief Pain Inventory-Modified Short Form-Severity weekly average pain item. The primary efficacy measure was the reduction in pain severity from baseline to 12weeks, as measured by the weekly mean of 24-h average pain ratings recorded in the patient′s diary. Mean changes from baseline in efficacy measures were analysed by a restricted maximum likelihood-based, mixed-effects model repeated measures approach and by analysis of covariance.

ResultsOf the 405 patients randomised, 203 patients were assigned to duloxetine 60mg once daily and 202 patients were assigned to placebo. Duloxetine-treated patients showed significantly greater pain relief on 24-h average pain ratings compared with placebo-treated patients each week of the 12-week study period [week 12: least squares (LS) mean change duloxetine: -2.40, placebo: -1.97; LS mean change difference (95% confidence interval)=-0.43 (-0.82, -0.04), p=0.030]. Compared with placebo, patients treated with duloxetine experienced higher rates of nausea (p=0.010), somnolence (p<0.001) and asthenia (p=0.002).

ConclusionsDuloxetine-treated patients showed significantly greater pain relief compared with placebo-treated patients over the 12-week study period. Duloxetine was shown in Chinese patients to have a safety profile similar to that found in previous duloxetine trials.

语种: 英语
项目资助者: Eli Lilly and Company
WOS记录号: WOS:000360448900007
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/60026
Appears in Collections:北京大学第一临床医学院_期刊论文

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作者单位: 1.Eli Lilly & Co, Indianapolis, IN 46285 USA
2.Eli Lilly Mexico, Mexico City, DF, Mexico
3.Eli Lilly Canada, Toronto, ON, Canada
4.Peking Univ, Hosp 1, Beijing 100871, Peoples R China
5.China Med Univ, Shengjing Hosp, Shenyang, Peoples R China
6.Shanghai Peoples Hosp 10, Shanghai, Peoples R China
7.Lilly Suzhou Pharmaceut Co Ltd, Shanghai, Peoples R China
8.Chinese Peoples Liberat Army, Artillery Gen Hosp 2, Beijing, Peoples R China
9.Chongqing Med Univ, Affiliated Hosp 2, Chongqing, Peoples R China

Recommended Citation:
Gao, Y.,Guo, X.,Han, P.,et al. Treatment of patients with diabetic peripheral neuropathic pain in China: a double-blind randomised trial of duloxetine vs. placebo[J]. INTERNATIONAL JOURNAL OF CLINICAL PRACTICE,2015,69(9):957-966.
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