TY - JOUR
T1 - Comparison of controlled-release and immediate-release oxycodone tablets in patients with cancer pain
AU - Kaplan, Ronald
AU - Parris, Winston C.
AU - Citron, Marc L.
AU - Zhukovsky, Donna
AU - Reder, Robert F.
AU - Buckley, Barbara J.
AU - Kaiko, Robert F.
N1 - Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 1998/10
Y1 - 1998/10
N2 - 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.
AB - 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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U2 - 10.1200/JCO.1998.16.10.3230
DO - 10.1200/JCO.1998.16.10.3230
M3 - Article
C2 - 9779696
AN - SCOPUS:0031752908
SN - 0732-183X
VL - 16
SP - 3230
EP - 3237
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 10
ER -