Journal of Clinical Oncology, Vol 16, 3230-3237, Copyright © 1998 by American Society of Clinical Oncology
Comparison of controlled-release and immediate-release oxycodone tablets in patients with cancer pain
R Kaplan, WC Parris, ML Citron, D Zhukovsky, RF Reder, BJ Buckley and RF Kaiko
Department of Anesthesiology Pain Service, Montefiore Medical Center, Bronx, NY, USA.
PURPOSE: This study compared the clinical efficacy of oxycodone
hydrochloride controlled-release (CR) tablets administered every 12 hours
with immediate-release (IR) oxycodone tablets administered four times daily
in patients with cancer-related pain. PATIENTS AND METHODS: Cancer patients
who required therapy for moderate to severe pain were randomized to CR
oxycodone every 12 hours (n=81) or IR oxycodone four times daily (n=83) for
5 days in a multicenter, double-blind study. Pain intensity was assessed
four times daily (categorical scale of none, slight, moderate, and severe);
acceptability of therapy was assessed twice daily (categorical scale of
very poor, poor, fair, good, and excellent). RESULTS: Pain intensity
remained slight during the study, with mean 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 fair to good with both treatments. While
standard conversion ratios provided an acceptable dose for many patients, a
protocol amendment that allowed initial titration and use of rescue
medication reduced the discontinuation rate for lack of acceptable pain
control (from 34% to 4% with CR and from 31% to 19% with IR before and
after amendment, respectively) without increasing the discontinuation rate
for adverse events (from 8% to 7% with CR and from 13% to 11% with IR).
Fewer adverse events were reported with CR (109) than with IR (186)
oxycodone (P=.006). CONCLUSION: CR oxycodone every 12 hours was as
effective as IR oxycodone four times daily in managing moderate to severe
cancer-related pain and was associated with fewer reports of adverse
events.
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