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| |  Cardiovascular safety profile of Vioxx (rofecoxib) confirmed WEST POINT, PA -- May 1, 2000 -- In response to speculative news reports, Merck & Co., Inc. confirmed the favorable cardiovascular safety profile of Vioxx(R) (rofecoxib), its medicine that selectively inhibits COX-2. Vioxx was approved by the U.S. Food and Drug Administration in May 1999 for the management of osteoarthritis and the relief of acute pain in adults based on efficacy and safety studies involving nearly 4,000 patients. Extensive review of data from the completed osteoarthritis trials and on- going clinical trials with Vioxx, as well as post-marketing experience with Vioxx, have shown NO DIFFERENCE in the incidence of cardiovascular events, such as heart attack, among patients taking Vioxx, other NSAIDs and placebo. More than 10 million prescriptions have been written for Vioxx in the United States since its introduction. In preliminary findings from Merck's large gastrointestinal (GI) outcomes study that compared Vioxx with naproxen in patients with rheumatoid arthritis, significantly fewer heart attacks were observed in patients taking naproxen (0.1 percent) compared to patients taking Vioxx (0.5 percent). This result is consistent with naproxen's ability to block platelet aggregation. This is the first time this effect of naproxen to reduce these events has been demonstrated in a clinical study. Vioxx, like all COX-2 selective medicines, does not block platelet aggregation and therefore would not be expected to have these effects in reducing these events. In a separate GI outcomes study in osteoarthritis and rheumatoid arthritis patients, celecoxib, another agent that selectively inhibits COX-2, was compared to NSAIDs diclofenac and ibuprofen. Pharmacia, maker of celecoxib, has indicated that there were no differences among celecoxib, ibuprofen and diclofenac on these cardiovascular events. In reports, the incidence of patients taking celecoxib who experienced a heart attack was cited as 0.5 percent, 0.3 percent among diclofenac patients, and 0.5 percent among patients taking ibuprofen. Further analyses are ongoing, and final results of the GI outcomes study with Vioxx will be presented at the Digestive Disease Week meeting on May 24, 2000. The recommended dose of Vioxx for the treatment of osteoarthritis is 12.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 25 mg once daily. Serious stomach problems, such as bleeding, can occur without warning symptoms. Administration of low-dose aspirin with Vioxx may result in an increased rate of GI ulcers or other complications compared to use of Vioxx alone. Physicians and patients should remain alert for signs and symptoms of gastrointestinal bleeding. Common side effects reported in osteoarthritis clinical trials with Vioxx were upper-respiratory infection, diarrhea, nausea and high blood pressure. People who have had an allergic reaction to Vioxx, aspirin or other NSAIDs should not take Vioxx. Safety and effectiveness in children below the age of 18 have not been studied. Merck & Co., Inc. is a global, research-driven pharmaceutical company that discovers, develops, manufactures and markets a broad range of human and animal health products, directly and through its joint ventures, and provides pharmaceutical benefit services through Merck-Medco Managed Care. Related Links: Vioxx (rofecoxib) and Merck & Co., Inc.
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