COMPARISON OF CONTROLLED-RELEASE AND IMMEDIATE-RELEASE OXYCODONE TABLETS IN PATIENTS WITH CANCER PAIN

Purpose: This study compared the clinical efficacy of oxycodone hydroc hloride controlled-release (CR) tablets administered every 12 hours wi th immediate-release (IR) oxycodone tablets administered four times da ily in patients with cancer-related pain. Patients and Methods: Cancer patients who required therapy for moderate to severe pain were random ized to CR oxycodone every 12 hours (n = 81) or IR oxycodone four time s daily (n = 83) for 5 days in a multicenter, double-blind study Pain intensity was assessed four times daily (categorical scale of none, sl ight, moderate, and severe); acceptability of therapy was assessed twi ce daily (categorical scale of very poor, poor, fair, good, and excell ent). Results: Pain intensity remained slight during the study, with m ean oxycodone doses of 114 mg/d (range, 20 to 400 mg/d) for CR and 127 mg/d (range, 40 to 640 mg/d) for IR, Acceptability of therapy was fai r to good with both treatments. While standard conversion ratios provi ded an acceptable dose for many patients, a protocol amendment that al lowed initial titration and use of rescue medication reduced the disco ntinuation rate for lack of acceptable pain control (from 34% to 4% wi th CR and from 31% to 19% with IR before and after amendment, respecti vely) without increasing the discontinuation rate for adverse events ( from 8% to 7% with CR and from 13% to 11% with IR), Fewer adverse even ts were reported with CR (109) than with IR (186) oxycodone (P =.006). Conclusion: CR oxycodone every 12 hours was as effective as IR oxycod one four times daily in managing moderate to severe cancer related pai n and was associated with fewer reports of adverse events. (C) 1998 by American Society of Clinical Oncology.