| |
Pain
|
|
| |
|
|
| |
|
|
|
|
|
my personal edition > pain > news
E-Mail this DGDispatch to a colleague
DGDispatch
Extended Release Avinza (Morphine Sulfate), Associated with Improved Physical Function in Osteoarthritis Patients: Presented at WCP
By Peggy Peck
Special to DG News
SAN DIEGO, CA -- August 20, 2002 -- In a double blind, placebo controlled trial Avinza™, a new once-daily extended release morphine sulfate formulation, improved physical function in patients with chronic moderate-to-severe osteoarthritis (OA) pain.
The research was reported here August 18th at the 10th World Congress on Pain.
Lead author Dr. Sanford H. Roth of the Arizona Research and Education Foundation, Phoenix, Arizona, USA said in an interview, "opioids are never the first tier treatment choice for osteoarthritis. But I think it is useful to point out that morphine is not end-organ toxic, which cannot be said for [nonsteroidal anti-inflammatory drugs]."
The study recruited 195 patients who were more than 40 years old and who had a diagnosis of OA of the hip or knee. A total of 184 patients completed the four-week study. The average age of patients was 62 and slightly less than half were women.
Patients were randomized to Avinza (formerly marketed as Morphelan™) 30 mg QAM (n=73), Avinza 30 mg QPM (n=73), MS Contin (MSC) 15 mg Q12H (n=76), or placebo Q12H (n=73) for four weeks. After completing the double-blind phase, patients could elect to enroll in a long-term extension trial receiving Avinza QAM or Avinza QPM, and could titrate to optimum pain control. A total of 86 patients completed this phase.
Physical function was measured by the SF-36 (Short-Form) and the Western Ontario & McMaster Universities Osteoarthritis (WOMAC) index at baseline and weekly for four weeks in the double-blind trial and at weeks 5, 8, 12, 18, 24, and 30 in the long-term trial. Eighty-six patients completed the open-label trial.
The SF-36 physical function summary score improved significantly (p</=.05) for the Avinza QAM and Avinza QPM groups at weeks 1, 2, and 4 and improved at all weeks in the extension trial.
Improvements in the WOMAC PF summary scale at week 4 compared to baseline were as follows: Avinza QAM 18 percent, Avinza QPM 19 percent, MSC 14 percent and placebo 8 percent. For the WOMAC index, statistically significant improvements in physical function for Avinza were seen from weeks 5 to 30. Improvements in physical function through week 12 corresponded with an increase in the mean daily Avinza dose. After week 12, physical function was stable as was the average daily dose of Avinza.
The most significant side effect was constipation, as expected. Forty-nine percent of patients on the morning regimen during the double blind phase reported constipation as did 37 percent of the patients on morning-dosing of Avinza in the long-term open label phase. Nighttime dosing was associated with constipation in 40 percent of patients in the double-blind phase and 32 percent of patients in the long-term phase.
All contents Copyright (c) 1995-2009 Doctor's Guide Publishing Limited. All rights reserved.
|
