• Pain Med · Jan 2012

    Randomized Controlled Trial Multicenter Study

    Sustained-release oxycodone tablets for moderate to severe painful diabetic peripheral neuropathy: a multicenter, open-labeled, postmarketing clinical observation.

    • Peng Yao, Ling-Xin Meng, Jia-Ming Ma, Yuan-Yuan Ding, Zhi-Bin Wang, Guo-Li Zhao, Rong Tao, Yan-Xiang Wu, Qiu-Shi Wang, Zhen Zhang, Yong-Dong Zhao, Shao-Wei Zhang, Jin-Feng Liu, Hong-Jie Guo, Gang Xu, and Bai-Shan Wu.
    • Department of Pain Management, Shengjing Hospital of China, Medical University, No.36, Sanhao Street, Heping District, Shenyang City 110004, China. yaopeng908@163.com
    • Pain Med. 2012 Jan 1;13(1):107-14.

    ObjectiveTo evaluate the efficacy and safety of sustained-release (SR) oxycodone tablets in the treatment of moderate to severe painful diabetic peripheral neuropathy (DPN). Design.  This was a multicenter, randomized, open-labeled study.SettingThis study was completed in 12 hospitals in China.PatientsA total of 80 Chinese patients undergoing moderate to severe painful DPN.InterventionsAn initial dose of 10mg is recommended to be taken orally every 12 hours. Dose titration was done appropriately according to pain intensity and adverse reactions.Outcome Measures  Data record included days, dosage, analgesic efficacy, quality of sleep, adverse events, and combination therapy when patients were treated with SR oxycodone tablets. The continuous observation period was 6 weeks.ResultsAfter medication for 1 week, pain was significantly (P<0.01) relieved from 6.8±1.4 to 2.8±1.6. Onset time was within 45 minutes in nearly 60% of the patients, and within 1 hour in nearly 95% of that ones. More than 90% of the patients achieved stable analgesic dose within 3 days. After using SR oxycodone tablets for 1 week, sleep quality was significantly (P<0.01) improved. In week 1, the average dose of SR oxycodone tablets was 16.63±7.79mg. The average daily dose of most patients was about 20mg after 2 weeks. In all the enrolled patients, 38 (47.5%) had adverse reactions. No serious adverse reactions took place.ConclusionThe results of this clinical observation further elaborated the efficacy and safety of SR oxycodone tablets in the treatment of moderate to severe painful diabetic peripheral neuropathy in China.Wiley Periodicals, Inc.

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