A large multicentre comparative efficacy, tolerability and quality of life trial between tts fentanyl and sustained release morphine, in strong-opioid naÏve patients with chronic low back pain

L Allan, L TookeThe Pain Clinic, Northwick Park Hospital, Harrow, UKBackground Low back pain is a common condition affecting approximately 80% of the population during their lifetime. It is not only a leading cause of disability in developed countries, but is also the most costly biopsychosocial chronic pain condition in the western world. Treatment of low back pain is unsatisfactory for many reasons, not least that an estimated 85% of patients presenting with back pain will not receive an adequate diagnosis. Optimum management relies upon a multimodal approach, where analgesia facilitates active rehabilitation. Recent primary care guidelines recommend that paracetamol should be used initially for treating joint pain, followed by the prescription of non-steroidal anti-inflammatories (NSAIDs). However, the significant morbidity, mortality and pharmacoeconomic implications associated with long term NSAID prescription, makes this an appropriate time to consider other therapies. Strong opioids have been shown to offer efficacy, safety and tolerability to patients with chronic non-cancer pain. Furthermore, strong opioids including TTS Fentanyl, have been shown to be effective and well tolerated specifically in patients with low back pain, although in small numbers. Objectives In a pragmatic, clinical based trial, approximately 600 strong-opioid naïve patients were enrolled in an international (16 European countries), randomised, open-label, parallel, multicentre (110 investigational centres), 13-month study. The objective of the study was to compare pain relief and the adverse event profile, achieved by TTS Fentanyl and sustained release morphine for chronic low back pain in strong opioid naïve patients. Outcome measures from the study included safety, QOL and outcome (the number of working days lost to chronic back pain) on TTS Fentanyl or sustained release morphine therapy. Methods Patients were prescribed the lowest dose TTS Fentanyl patch (25 μg/h) every 72 h, with incremental titration of 25 μg/h to achieve adequate pain control. Patients randomised to sustained release morphine started on 30 mg sustained release morphine 12-hourly, titrated up in 30–50% increments after a minimum of 12 h to achieve adequate pain control. Safety assessments were conducted throughout the study. Results The results of the interim analysis detailing patient demographics, disposition, and characteristics of the chronic pain, will be presented in the poster. Conclusion References Biering-Sorensen F, Bendix AF. Lancet 2000;355:1929–30 Eccles M, et al . BMJ 1998;317: 526–30 Tramer MR, et al . Pain 2000;85:169–82 Moore RA, et al . J Med Econ. 1999;2:45–55 Allan L, et al . BMJ 2001, accepted Simpson RK, et al . J Pain Symptom Manage 1997;14:218–24 Jamison RN, et al . Spine 1998;23:2591–600 Citation: Ann Rheum Dis, volume 60, supplement 1, year 2001, page A217Session: Back Pain