Background Persistent and misplaced fears about the risks of tolerance, physical dependence and addiction have led to the underuse of opioids for the treatment of chronic non-cancer pain (CNCP). Opioids are widely used for the alleviation of acute pain and cancer pain, and are established as the second and third steps of the World Health Organisation analgesic ladder. Evidence suggests, however, that pain is frequently undertreated even for these indications.1 Nevertheless, several short-term, randomised controlled trials have shown that opioids can be used successfully to treat CNCP without causing undue adverse events.2–4 A previous randomised crossover trial demonstrated that, over a 2-month period, 256 patients with CNCP preferred transdermal fentanyl (TDF) to sustained-release oral morphine due to better pain control, less constipation and some improvements in quality-of-life parameters.5 Although these short-term data are encouraging, no prospective trials have assessed the long-term efficacy and safety of opioid analgesia in CNCP.
Objectives The objectives of this international, multicenter, open-label trial were to assess the efficacy and safety of up to 12 months? therapy with TDF in patients with CNCP.
Methods The efficacy and safety of up to 12 months? therapy with TDF was assessed in patients with CNCP who required continuous opioid analgesia. Patients? opioid preference (compared with their previous analgesic), pain control and quality of life were evaluated. TDF therapy was initiated at an equianalgesic dose to pre-trial opioids, then titrated to maintain acceptable pain control and side-effects.
Results Of the 532 patients recruited, 301 (57%) completed the full 12-month trial. A total of 530 patients were included in the safety analysis and 524 in the efficacy analysis. During the study 130 patients (25%) from the efficacy group withdrew because of adverse events and 39 (7%) due to insufficient analgesia. Weekly assessments indicated that the percentage of patients who perceived pain control as very good, good or moderate remained stable over 12 months, at an average of 67%, with 47% citing better analgesia and 27% convenience as the main reason. Global treatment satisfaction also remained stable, with 42% reporting very good or good pain control. Medical Outcomes Study (MOS) and Short Form 36 (SF-36) quality-of-life measures showed improvements after 12 months? treatment compared with baseline. The most common adverse events were nausea, somnolence, constipation, vomiting and increased sweating. One of the nine deaths during the trial was considered possibly related to TDF treatment (severe bronchopneumonia). No problems of opioid withdrawal symptoms or addiction were encountered.
Conclusion Long-term TDF treatment produced stable analgesia in patients with CNCP and was preferred by the majority of patients to their previous medication. TDF was generally well tolerated in comparison with similar agents.
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