Postmarketing surveillance study of OxyContin tablets for relieving moderate to severe cancer pain.

OBJECTIVE

To evaluatethe efficacy and safety of OxyContin tablets (controlled-release oxycodone hydrochloride: 5, 10, 20, and 40 mg) in relieving moderate to severe cancer pain.

METHOD: A multicenter, open-label, prospective, self-controlled clinical trial was used.

RESULTS

Pain was relieved in 89.1% of patients within 1 h after drug administration. OxyContin tablets showed good clinical efficacy in relieving both moderate and severe cancer pain. Compared with baseline average pain scores of 6.9 +/- 1.4, subjects had lower average pain scores after administration of OxyContin tablets: 2.7 +/- 1.8 after 1 week and 2.1 +/- 1.5 after 2 weeks. Response rate reached 75.0% at the end of the 1st week and was maintained at approximately 90% from the 3rd to the 8th week. The most common adverse drug reactions (ADRs) caused by OxyContintablets were, in descending order of incidence rate: constipation (25.5%), nausea (13.3%), vomiting (6.2%), lethargy (3.7%), and dysuria (2.1%). All these ADRs could be decreased by preventive medications.

CONCLUSION

OxyContin tablets demonstrated fast onset of cancer pain control, superior efficacy in relieving both moderate and severe cancer pain and a good safety profile.