|Efficacy of Pregabalin for Peripheral Neuropathic Pain: Results of an 8-Week, Flexible-Dose, Double-Blind, Placebo-Controlled Study Conducted in China|
|Guan, Yuzhou; Ding, Xinsheng2; Cheng, Yan3; Fan, Dongsheng4; Tan, Lan5; Wang, Yongjun6; Zhao, Zhongxin7; Hong, Zhen8; Zhou, Dong9; Pan, Xiaoping10; Chen, Shengdi11; Martin, Andrew12; Tang, Haiyun13; Cui, Liying1|
|关键词||diabetic peripheral neuropathy neuropathic pain postherpetic neuralgia pregabalin|
|WOS标题词||Science & Technology|
|类目[WOS]||Pharmacology & Pharmacy|
|研究领域[WOS]||Pharmacology & Pharmacy|
|关键词[WOS]||POSTHERPETIC NEURALGIA ; DIABETIC-NEUROPATHY ; CONTROLLED-TRIAL ; EPIDEMIOLOGY ; GUIDELINES|
Background: Several classes of medications such as tricyclic antidepressants, anticonvulsants, narcotic analgesics, and alpha 2-delta ligands, such as pregabalin, have been reported to be efficacious in the treatment of painful diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN) in whites. However, no large double-blind, placebo-controlled trials have been reported that evaluated the efficacy of pregabalin for the treatment of neuropathic pain in a Chinese population in China.
Objective: The aim of this study was to evaluate the efficacy and tolerability of flexible-dose pregabalin in treatment of Chinese patients diagnosed with painful DPN or PHN.
Methods: This was a double-blind, parallel-group study in which patients were randomized in a 2:1 ratio and treated with either flexible-dose pregabalin, 150 to 600 mg/d, or corresponding flexible-dose placebo for 8 weeks. The primary efficacy end point was change in the mean pain score based on a daily pain rating scale (DPRS; ranging from 0 [no pain] to 10 [worst possible pain]). Secondary end points included Daily Sleep Interference scale, short form-McGill Pain Questionnaire (SF-MPQ) scale, and the Patient Global Impression of Change (PGIC) and Clinician Global Impression of Change (CGIC) scales. Adverse events and physical and laboratory examination results were also collected.
Results: Pregabalin and placebo treatment groups were well-matched in terms of demographic and patient characteristics. On the primary outcome, end point change in mean DPRS score, treatment with pregabalin (N = 206) resulted in significant improvement compared with results with placebo (N = 102), with a least squares mean difference score of -0.6 (P = 0.005). With regard to responder rates, 64% and 52% of patients treated with pregabalin and placebo, respectively, reported >= 30% improvement in DPRS scores (P = 0.04). Treatment with pregabalin also resulted in significant efficacy compared with that of placebo on secondary measures, including SF-MPQ VAS score (P = 0.012), SF-MPQ present pain intensity index score (P = 0.003), sleep interference score (P = 0.023), and PGIC and CGIC scores (P = 0.004 and P = 0.001, respectively). Adverse events were observed in 50.0% of pregabalin patients and 40.2% of placebo patients (P = 0.105), with the most common adverse event being dizziness (11.2%).
Conclusions: Study results suggest that relative to placebo, pregabalin in daily doses of 150 to 600 mg/d was effective and well tolerated in Chinese patients diagnosed with moderate-to-severe DPN or PHN, indicated through improved pain scores and PGIC scores. (Clin Ther. 2011;33:159-166) (C) 2011 Elsevier HS Journals, Inc. All rights reserved.
|资助机构||Pfizer Inc, New York, New York ; Pfizer Inc.|
|作者单位||1.Beijing Union Med Coll Hosp, Dept Neurol, Beijing 100730, Peoples R China|
2.Nanjing Med Univ, Affiliated Hosp 1, Jiangsu Prov Peoples Hosp, Nanjing, Peoples R China
3.Tianjin Med Univ, Gen Hosp, Tianjin, Peoples R China
4.Peking Univ, Hosp 3, Beijing 100871, Peoples R China
5.Qingdao Univ, Med Coll Hosp, Qingdao 266071, Peoples R China
6.Beijing Tiantan Hosp, Beijing, Peoples R China
7.Shanghai Changzheng Hosp, Shanghai, Peoples R China
8.Huashan Hosp, Shanghai, Peoples R China
9.Sichuan Univ, W China Hosp, Chengdu 610064, Peoples R China
10.Guangzhou First Municipal Peoples Hosp, Guangzhou, Guangdong, Peoples R China
11.Ruijin Hosp, Shanghai, Peoples R China
12.Pfizer Global Res & Dev, New York, NY USA
13.Pfizer Inc, Shanghai, Peoples R China
|Guan, Yuzhou,Ding, Xinsheng,Cheng, Yan,et al. Efficacy of Pregabalin for Peripheral Neuropathic Pain: Results of an 8-Week, Flexible-Dose, Double-Blind, Placebo-Controlled Study Conducted in China[J]. CLINICAL THERAPEUTICS,2011,33(2):159-166.|
|APA||Guan, Yuzhou.,Ding, Xinsheng.,Cheng, Yan.,Fan, Dongsheng.,Tan, Lan.,...&Cui, Liying.(2011).Efficacy of Pregabalin for Peripheral Neuropathic Pain: Results of an 8-Week, Flexible-Dose, Double-Blind, Placebo-Controlled Study Conducted in China.CLINICAL THERAPEUTICS,33(2),159-166.|
|MLA||Guan, Yuzhou,et al."Efficacy of Pregabalin for Peripheral Neuropathic Pain: Results of an 8-Week, Flexible-Dose, Double-Blind, Placebo-Controlled Study Conducted in China".CLINICAL THERAPEUTICS 33.2(2011):159-166.|