|San Diego, CA|
|November 15, 2005|
|Results of study presented at the 2005 American College of Rheumatology Annual Meeting in San Diego|
Results of a six-month study suggest that Hyalgan® (sodium hyaluronate) intra-articular therapy is effective for treatment of chronic shoulder pain due to osteoarthritis (OA).
The data presented at the 2005 American College of Rheumatology Annual Meeting in San Diego show that patients receiving either three or five weekly Hyalgan® injections experienced a statistically significant reduction in pain compared to the control group (p=0.0026 and 0.0023) after six months. In addition, pain reduction was numerically better in the patients receiving Hyalgan® after three months than the control group (p=0.051 and 0.058). “This study shows that Hyalgan® relieves shoulder pain in the majority of patients with osteoarthritis of the shoulder,” said Dr. Roy Altman, Professor of Medicine in the Division of Rheumatology at the University of California, Los Angeles.
The double-blind, randomized, saline-controlled study of 602 patients was designed to measure pain on movement following regular Hyalgan® treatments vs. placebo over the course of three and six months. Three separate study groups were given either five weekly Hyalgan® injections, three weekly Hyalgan® injections followed by two weeks placebo injections or five weekly placebo injections.
The patients were both men and women over the age of 35 and an average age of 63, with moderate-to-severe chronic shoulder pain due to glenohumeral joint OA, rotator cuff tear, and/or adhesive capsulitis. They had limited range of motion and failed to respond adequately to physical therapy, steroid (cortisone related medication) injection, and oral analgesics. The treatments were well tolerated by patients in all groups, with a low incidence of injection-site pain (<1%). The most common adverse events reported from this study were arthralgia (7.4%), nasopharyngitis (4.5%) and headache (3.3%).
In the US clinical trial of 495 patients, the only adverse event showing statistical significance vs. placebo was injection-site pain.
Other adverse events included gastrointestinal complaints, headache, local ecchymosis and rash, local joint pain and swelling, and local pruritus. However, the incidence of these events was similar in the Hyalgan® and placebo groups.
In other clinical studies, the frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle.
About Osteoarthritis of the Shoulder
According to the American Academy of Orthopaedic Surgeons, common symptoms of osteoarthritis of the shoulder include pain and limited range of motion, which are oftentimes aggravated by movement.
Please see accompanying full Prescribing Information for Hyalgan® (sodium hyaluronate) or log on to www.hyalgan.com.
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Forward Looking Statements
Sanofi-aventis Group subsidiaries in the United States include Sanofi-Synthelabo Inc., Aventis Pharmaceuticals Inc. and Sanofi Pasteur Inc.
Amy Ba, 908.243.4261, firstname.lastname@example.org.