Merck & Co Inc will present data from its APPROVe (Adenomatous Polyp Prevention on Vioxx) clinical trial at the American College of Rheumatology (ACR) Annual Scientific Meeting in San Antonio on Oct. 18. Earlier, the company announced a voluntary worldwide withdrawal of Vioxx (rofecoxib), its arthritis and acute pain medication from the marketplace worldwide on Sept 30, based on new, three-year data from the trial.
The company took the action because, in this study, there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after18 months of treatment in the patients taking Vioxx compared to those taking placebo. The results for the first 18 months of the APPROVe study did not show an increased risk of confirmed cardiovascular events on Vioxx and, in this respect, are similar to the results of two placebo-controlled studies described in the US labelling for Vioxx. The study, which was stopped, was designed to evaluate the efficacy of Vioxx 25 mg in preventing recurrence of colorectal polyps in patients with a history of colorectal adenomas, the company says.
Merck had requested the opportunity to present the data at the ACR meeting. ACR has planned a special session at the ACR/ARHP Annual Scientific Meeting to review data from the APPROVe trial. The special session, "Rofecoxib APPROVe Study Results and Their Implications," will be held on Monday, Oct. 18, from 6 to 6:30 p.m. in Ballroom C2-3 of the Henry B. Gonzalez Convention Centre for registered attendees, the Merck release added.
The session will include a scientific presentation by Robert Bresalier, chair, Gastrointestinal Medicine & Nutrition at the University of Texas M.D. Anderson Cancer Centre in Houston, and Alise Reicin, vice president, clinical research, Merck & Co Inc. Dr. Bresalier is a member of the Executive Steering Committee for the APPROVe trial.