Duloxetine versus placebo in the treatment of patients with diabetic neuropathic pain in China

• Published in: Chinese medical journal Vol. 123; no. 22; pp. 3184 - 3192
• Main Authors: Gao, Yan, Ning, Guang, Jia, Wei-Ping, Zhou, Zhi-Guang, Xu, Zhang-Rong, Liu, Zhi-Min, Liu, Chao, Ma, Jian-Hua, Li, Qiang, Cheng, Lu-Lu, Wen, Chong-Yuan, Zhang, Shu-Yu, Zhang, Qi, Desaiah, Durisala, Skljarevski, Vladimir
• Format: Journal Article
• Language: English
• Published: China Department of Endocrinology,Peking University First Hospital,Beijing 100034,China%Department of Endocrinology,Shanghai Ruijin Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China%Department of Endocrinology,Shanghai Sixth People's Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200233,China%Department of Endocrinology,Xiangya Second Hospital,Central South University,Changsha,Hunan 410011,China%Department of Endocrinology,306 Hospital of People's Liberation Army,Beijing 100101,China%Department of Endocrinology,Chang Zheng Hospital,Second Military Medical University,Shanghai 200003,China%Department of Endocrinology,First Affiliated Hospital of Nanjing Medical University,Nanjing,Jiangsu 210029,China%Department of Endocrinology,Nanjing First Hospital,Nanjing Medical University,Nanjing,Jiangsu 210006,China%Department of Endocrinology,Second Affiliated Hospital of Harbin Medical University,Harbin,Heilongjiang 150086,China%Department of Endocrinology,Union Hospital,Huazhong University of Science and Technology,Wuhan,Hubei 430022,China%Department of Endocrinology,Renmin Hospital of Wuhan University,Wuhan,Hubei 430060,China%Lilly Research Laboratories,Eli Lilly and Company,Indianapolis,IN,USA 46285 20.11.2010
• Subjects: Adrenergic Uptake Inhibitors - therapeutic use; Aged; Diabetic Neuropathies - drug therapy; Double-Blind Method; Duloxetine Hydrochloride; Female; Humans; Male; Middle Aged; Placebos; Thiophenes - therapeutic use; Treatment Outcome; 去甲肾上腺素; 周围神经; 度洛西汀; 治疗效果; 糖尿病; clinical trial; duloxetine; Chinese patients; diabetic peripheral neuropathic pain
• ISSN: 0366-6999; 2542-5641; 2542-5641
• DOI: 10.3760/cma.j.issn.0366-6999.2010.22.003

Background Duloxetine, a selective serotonin and noradrenaline reuptake inhibitor, has been shown to be effective in treatment of diabetic peripheral neuropathic pain and approved for the management of patients with diabetic peripheral neuropathic pain （DPNP） in the United States, European Union, and many other countries. This study assessed the efficacy and safety of duloxetine in Chinese patients with diabetic peripheral neuropathic pain. Methods This double-blind, randomized, placebo-controlled, flexible-dose study treated adult patients with diabetic peripheral neuropathic pain and baseline Brief Pain Inventory （BPI） 24-hour average pain severity ratings ≥4 with duloxetine 60 mg to 120 mg once daily or placebo for 12 weeks. Dose adjustments of duloxetine or matching placebo were based upon investigator＇s judgment of clinical response. Change from baseline to endpoint in BPI average pain was the primary efficacy outcome. Secondary outcome measures included BPI-severity and -Interference, Patient Global Impression of Improvement, Clinical Global Impressions of Severity, EuroQol： 5 Dimensions, Athens Insomnia Scale, and safety measures. Results Of 215 patients randomized, 88.4% and 82.1% of patients in placebo and duloxetine groups, respectively,completed the study. Mean change from baseline to endpoint in BPI average pain was not statistically different between the treatment groups （P=0.124）. Duloxetinetreated patients showed significantly greater pain reduction compared with those in placebo group at weeks 1,2, and 4 （P=0.004, P=0.009, and P=0.006, respectively） but not at weeks 8 （P=0.125） and 12 （P=0.107）. Duloxetine-treated patients experienced statistically significant improvement in Patient Global Impression of Improvement, Clinical Global Impression of Severity, area under the curve for pain relief, BPI-severity pain right now, and BPI-interference walking ability. Patients treated with duloxetine 120 mg once daily showed significantly greater pain reduction on the Brief Pain Inventory average pain score relative to placebo. Duloxetine-treated patients reported nausea, somnolence, anorexia, and dysuria significantly more than placebo. Conclusions Although the primary study endpoint was not achieved, the overall observed response pattern suggests the efficacy of duloxetine in the treatment of Chinese patients with diabetic peripheral neuropathic pain. The safety profile for duloxetine is similar to that reported in other global trials.