Oxycodone hydrochloride controlled-release tablets (OxyContin®): post-marketing surveillance (PMS) study for relieving moderate to severe non-cancer pain

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• 作者：Huang Yuguang ; Fan Bifa ; Fang Wenxue ; Du Dongping ; Xu Hua ; Zhu Shengmei ; Zhao Guodong ; Xu Meng ; Luo Rongcheng ; Lu Zhenhe ; Xu Jianguo ; Ni Jiaxiang ; Zheng Baosen ; Song Wenge ; Lin Jian ; Cui Jianjun ; Chen Zhendong
• 关键词：Oxycodone CR tablets ; Non-cancer pain ; PMS ; Pain management
• 刊名：European Journal of Pain Supplements
• 出版年：2007
• 出版时间：September 2007
• 年：2007
• 卷：1
• 期：1
• 页码：41-47
• 全文大小：154 K

文摘

Objective

To evaluate the efficacy and safety of oxycodone hydrochloride controlled-release (CR) tablets (Oxycontin®, Mundipharma International Limited, Cambridge, UK), 5 mg, 10 mg, 20 mg, and 40 mg in relieving moderate to severe non-cancer pain.

Method

Two multi-center, open-label, prospective, self-controlled clinical trial, used identical protocols. All the subjects were patients with moderate to severe non-cancer pain. The clinical data were collected in the natural course of clinical treatment.

Results

Treatments with oxycodone CR tablets was associated with fast onset on pain relief; 85.2 % of patients in study 1 and 91.8 % of patients in study 2 achieved pain relief within 1 hour of drug administration.

Clinical efficacy

Both studies demonstrated that oxycodone CR tablets showed good clinical efficacy for relieving both moderate and severe non-cancer pain. Patients experienced sustained pain relief from the first week of treatment. Patients in both study 1 and study 2 experienced a dramatic pain score reduction (as assessed by VAS) after the first week of treatment.

Safety profile

During oxycodone CR treatment, use of concomitant medications decreased significantly. A few patients developed ADRs in the first week, which decreased significantly as the treatment continued. Constipation was the most common ADR in the first week, which decreased to 10 % of patients from the second week of treatment.

Conclusion

Oxycodone CR tablets demonstrated fast onset of pain control and superior efficacy for relieving both moderate and severe non-cancer pain, as well as significant reductions in the number of concomitant medications, demonstrating a good safety profile.