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 after 18 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 U.S. labeling 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.
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 Center for registered attendees.
The session will include a scientific presentation by Robert Bresalier, M.D., Chair, Gastrointestinal Medicine & Nutrition at the University of Texas M.D. Anderson Cancer Center in Houston, and Alise Reicin, M.D., vice president, clinical research, Merck & Co., Inc. Dr. Bresalier is a member of the Executive Steering Committee for the APPROVe trial.
In addition, the session will include a brief comment from a representative of the Food and Drug Administration and an opportunity for questions and discussion.
The call in number to listen to the presentation is 800-443-6324.
Merck & Co., Inc. is a global research-driven pharmaceutical company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2003, and in its periodic reports on Form 10-Q and Form 8-K (if any), which the company incorporates by reference.