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J Pain Symptom Manage · Dec 2016
Randomized Controlled Trial Multicenter Study Comparative StudyComparison of the tolerability profile of controlled release oral morphine and oxycodone for cancer pain treatment. An open label randomized controlled trial.
- Ernesto Zecca, Cinzia Brunelli, Paola Bracchi, Giuseppe Biancofiore, Carlo De Sangro, Roberto Bortolussi, Luigi Montanari, Marco Maltoni, Cecilia Moro, Ugo Colonna, Gabriele Finco, Maria Teresa Roy, Vittorio Ferrari, Oscar Alabiso, Giovanni Rosti, Stein Kaasa, and Augusto Caraceni.
- Palliative Care, Pain Therapy and Rehabilitation Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
- J Pain Symptom Manage. 2016 Dec 1; 52 (6): 783794.e6783-794.e6.
ContextOxycodone and morphine are recommended as first-choice opioids for moderate/severe cancer pain, but evidence about their relative tolerability has significant methodological limitations.ObjectivesThis study was mainly aimed at comparing the risk of developing adverse events (AEs) with controlled-release oral morphine vs. oxycodone; secondary aims were comparing their analgesic efficacy and testing heterogeneity in tolerability across different age and renal function subgroups.MethodsAn open-label multicenter RCT (EudraCT number: 2006-003151-21) was carried out in patients with moderate/severe cancer pain. At baseline, 7 and 14 days, patients scored on 0-10 rating scales (0-10 numerical rating scale) the intensity of pain and of a list of common opioid side effects. The primary end point was the percentage of patients reporting an AE (a worsening ≥ 2 points on any of the listed side effects); tolerability by subgroups and average follow-up pain intensity were compared through regression models.ResultsOne hundred eighty-seven patients were enrolled (47% of originally planned). Intention to treat (ITT) analysis (N = 185, morphine 94, oxycodone 91) did not show any difference in the risk of developing AEs (risk difference -0.6%, 95% CI -11.0% to 9.9%) nor in analgesia (0-10 numerical rating scale pain intensity difference -0.28, 95% CI -0.83 to 0.27). No evidence of heterogeneity of tolerability across age and renal function patient subgroups emerged.ConclusionThis trial failed to show any difference in tolerability and analgesic efficacy of morphine and oxycodone as first-line treatment for moderate/severe cancer pain but results interpretation is difficult due to lack of power, potential bias from open-label design, and concerns about assay sensitivity. These data, however, can significantly contribute to future meta-analyses comparing WHO Step-III opioids and are relevant in designing future randomized studies.Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.
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