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EFIC: New Data Confirms Expanded Role for Fentanyl Transdermal System in Treatment of Osteoarthritis, Rheumatoid Arthritis and Lower Back Pain PRAGUE, CZECH REPUBLIC -- September 4, 2003 -- Results of two new large, studies show that strong opioid analgesics like the fentanyl transdermal system (Durogesic®) are an effective option for alleviating moderately severe to severe chronic pain associated with osteoarthritis, rheumatoid arthritis and lower back pain. With the incidence of musculoskeletal conditions increasing in both the western and developing world1, the results presented today at the 4th Congress of the European Federation of ISAP Chapters (EFIC) offer new hope for these patients who suffer from lifelong uncontrolled pain. In a study of 263 patients with osteoarthritis (n=159) and rheumatoid arthritis (n=104), 45% of patients treated with the fentanyl patch reported 'good' or 'excellent' pain control (35% reported moderate pain control) resulting in improvements in functionality such as dressing, bathing, eating and walking.2 In a second study, which is one of the most extensive studies to evaluate the efficacy and safety of strong opioids in the treatment of chronic back pain, 683 patients were assessed over a period of 13 months. Approximately half of the patients were treated with the three-day fentanyl patch and the remaining patients received Sustained Release Morphine (SRM) (administered orally twice daily). While the fentanyl patch was found to be equivalent to SRM for overall pain relief, the fentanyl patch was significantly better than SRM with respect to "at rest" pain relief (p=0.032) and "during the night"(p=0.005) pain relief. In addition, 48% of patients taking SRM experienced constipation at endpoint, compared to only 31% of those treated with the fentanyl patch (p < 0.001).3 Dr Wilfried Ilias, Head of the Department of Anaesthesia, Intensive Care and Pain Management at the Hospital of the Order of Saint John of God, Vienna, Austria commented, "While traditional treatment approaches for people with musculoskeletal conditions have focused on relieving inflammation, pain management is often left uncontrolled. Although the use of stronger painkillers has been viewed with some hesitancy among the medical community, this new research shows overall benefits that translate into real, practical advantages for patients, greatly improving quality of life." Today's data are in line with recommendations presented at EFIC, which set out a framework for the use of strong opioids in the treatment of chronic pain.4 Among the recommendations the authors state that, where possible, long-acting opioid preparations (such as oral sustained release tablets or transdermal systems) should be used. "On demand" administration should be avoided and patients' progress should be monitored carefully to assess treatment response. Dr Ilias continued, "Patients with musculoskeletal pain appear to achieve a two-fold benefit with the fentanyl patch. Not only do they experience pain relief resulting in improved functionality, but also fewer side effects compared with those taking sustained release morphine. The fentanyl patch also seems to offer a further benefit in that pain relief can be provided around-the-clock, especially at rest and during the night." The fentanyl patch was generally well tolerated by study participants. The most common side effects included nausea, vomiting, constipation, somnolence, and dizziness which are those typically seen with opioid analgesic use. The side effects were mild to moderate and decreased over time. The majority of patients experienced long term pain relief without the need for continuous dose increase. These studies were conducted by Johnson & Johnson Pharmaceutical Research and Development. Study Design · Osteoarthritis/Rheumatoid Arthritis Study (FEN-INT-30) This was an open-label study of subjects with rheumatoid arthritis or osteoarthritis of the knee or hip, in which the degree of pain control was assessed. Pain was controlled by nonsteroidal anti-inflammatory drugs (NSAIDS), COX2-inhibitors, paracetamol or weak opioids. Current medication was optimised during a one-week run-in: non-opioid analgesics were raised to the maximum tolerated dose, weak opioids were stabilized. Participants who still had pain after the run-in received 25mcg/h fentanyl patches (Durogesic™), the dose could be increased every 3 days if required. Other opioids were discontinued, non-opioid analgesic doses were normalized. Paracetamol (max 4g/day) was available for incident pain. All participants received metoclopramide for the first week. TDF treatment was continued for 28 days. Pain control was assessed at baseline, then after 7, 14 and 28 days. - Chronic Low Back Pain (FEN-INT-26) This was an open, multi-center, randomised, parallel group trial comparing fentanyl patch with sustained release morphine (SRM) in strong opioid naïve patients with chronic low back pain. At least 600 patients, meeting the inclusion and exclusion criteria, were to be centrally randomised to treatment with either fentanyl patch or SRM for 13 months. Patients with chronic low back pain, whose pain had reached the stage requiring continuous treatment with a strong opioid, were eligible for entering the trial. References: 1. The Global Economic and Healthcare Burden of Musculoskeletal Diseases, www.bonejointdecade.org 2. Le Loet X, Bjorneboe O, Pavelka K, Herrero-Beaumont G. Effects of transdermal fentanyl on pain and functioning in patients with arthritis. Abstract presented at the EFIC Congress, September 2003. 3. Allan L, Kalso E. Randomized trial of transdermal fentanyl and sustained release oral morphine in chronic low back pain. Abstract presented at the EFIC Congress, September 2003. 4. Kalso E et al. Recommendations for using opioids in chronic non-cancer pain. Abstract presented at the EFIC Congress, September 2003. SOURCE: Resolute Communications Ltd E-mail this page to a friend or colleague! To print, use this version