If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Hydromorphone Extended-Release Improves Pain Relief, Quality of Life Among Low Back Pain Patients: Presented at APS By Ed Susman SAN DIEGO -- May 13, 2009 -- Patients with low back pain indicated improvement in their pain relief hydromorphone extended-release once-daily therapy, researchers stated here at the 28th Annual Scientific Meeting of the American Pain Society (APS). "The efficacy and safety of once-daily hydromorphone extended release were maintained throughout the 6-month treatment period," said John Thipphawong, MD, Johnson&Johnson Pharmaceutical Research and Development, Fremont, California. The original study established the once-daily treatment was effective over a 28-day course of therapy. The drug's push-pull delivery system employs a push layer that expands when fluid from the gastrointestinal tract permeates the outer membrane and pushes the drug out at a steady rate through the delivery orifice in the tablet member, Dr. Thipphawong explained in a poster presentation on May 8. The study recruited 113 patients into the open-label extension trial, but 1 patient was lost to follow-up and was not evaluated in the analysis. Eventually, 83 patients completed the extension of the study. "Mean pain relief rating and mean results for the Brief Pain Inventory scores were significantly improved at all assessments compared with baseline," Dr. Thipphawong reported. "The results of this study show that once-daily extended release hydromorphone was an efficacious and well-tolerated option for patients with chronic low back pain." He said the assessment of the study is limited because of the open-nature of the trial but the results do provide an evaluation of clinical utility and safety. Dr. Thipphawong said that the significant differences from baseline that were achieved in the original study of the system were maintained through the 6-month extension of the trial, including those improvements in pain and in quality of life as measured by the SF-36 physical (P < .0001) and mental (P = .0006) assessments. "Hydromorphone is safe and effective for managing moderate to severe pain," he said. "However, a once-daily form is not currently available in the United States." In the extension study, about 64% were women; the average age of the participants was 47.5 years; and 95% of the patients were white. The patients were offered treatment of 8, 16, 32, and 64 mg in the once-daily formulations. To qualify for the extension study, patients had to have a diagnosis of low back pain, and a need for at least 8 mg of hydromorphone a day. Funding for this study was provided by Knoll Pharmaceutical Company, ALZA Corporation, and Neuromed Pharmaceuticals Ltd. [Presentation title: Open-Label Extension Study on the Long-Term Efficacy, Safety, and Impact on Quality of Life of OROS Hydromorphone Extended Release in Patients With Chronic Low Back Pain. Abstract 88]
|
