Comparison of controlled-release and immediate-release oxycodone tablets in patients with cancer pain

被引:60
作者
Kaplan, R
Parris, WCV
Citron, ML
Zhukovsky, D
Reder, RF
Buckley, BJ
Kaiko, RF
机构
[1] Purdue Pharma LP, Norwalk, CT 06850 USA
[2] Montefiore Med Ctr, Dept Anesthesiol, Pain Serv, Bronx, NY 10467 USA
[3] Long Isl Jewish Med Ctr, Inst Oncol, New Hyde Pk, NY 11042 USA
[4] N Shore Univ Hosp, Don Monti Div Hematol Oncol, Manhasset, NY USA
[5] Vanderbilt Univ Sch Med, Dept Anesthesiol, Nashville, TN USA
关键词
D O I
10.1200/JCO.1998.16.10.3230
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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. (C) 1998 by American Society of Clinical Oncology.
引用
收藏
页码:3230 / 3237
页数:8
相关论文
共 29 条
  • [21] DIVERGENT TRADITIONS IN ANALGESIC CLINICAL-TRIALS
    MAX, MB
    [J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 1994, 56 (03) : 237 - 241
  • [22] METHODOLOGICAL PROBLEMS IN MEASUREMENT OF PAIN - COMPARISON BETWEEN VERBAL RATING SCALE AND VISUAL ANALOG SCALE
    OHNHAUS, EE
    ADLER, R
    [J]. PAIN, 1975, 1 (04) : 379 - 384
  • [23] PAALZOW LK, 1995, SWED AC PHARM SCI FI
  • [24] A REVIEW OF OXYCODONES CLINICAL PHARMACOKINETICS AND PHARMACODYNAMICS
    POYHIA, R
    VAINIO, A
    KALSO, E
    [J]. JOURNAL OF PAIN AND SYMPTOM MANAGEMENT, 1993, 8 (02) : 63 - 67
  • [25] ABUSE POTENTIAL AND PHARMACOLOGICAL COMPARISON OF TRAMADOL AND MORPHINE
    PRESTON, KL
    JASINSKI, DR
    TESTA, M
    [J]. DRUG AND ALCOHOL DEPENDENCE, 1991, 27 (01) : 7 - 17
  • [26] Steady-state bioavailability of controlled-release oxycodone in normal subjects
    Reder, RF
    Oshlack, B
    Miotto, JB
    Benziger, DD
    Kaiko, RF
    [J]. CLINICAL THERAPEUTICS, 1996, 18 (01) : 95 - 105
  • [27] Reisine T., 1996, GOODMAN GILMANS PHAR, P521
  • [28] Analgesic efficacy of controlled-release oxycodone in postoperative pain
    Sunshine, A
    Olson, NZ
    Colon, A
    Rivera, J
    Kaiko, RF
    Fitzmartin, RD
    Reder, RF
    Goldenheim, PD
    [J]. JOURNAL OF CLINICAL PHARMACOLOGY, 1996, 36 (07) : 595 - 603
  • [29] Watson CPN, 1998, NEUROLOGY, V50, P1837