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New Drug Treatment Causes Fewer GI Events in Rheumatoid Arthritis Patients

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By News Release • www.ProHealth.com • March 27, 2000


SUMMARY: Among patients treated with Vioxx, there was a significantly reduced incidence of serious gastrointestinal events compared to patients treated with naproxen. In addition, significantly fewer thromboembolic (associated with the blocking of a blood vessel by a particle that has broken away from a blood clot) events were observed in patients taking naproxen in this GI outcomes study, which is consistent with naproxen's ability to block platelet aggregation (& disrupt cardioprotection). However, Vioxx, like all COX-2 (the enzyme that triggers pain and inflammation) selective medicines, does not block platelet aggregation and therefore does not interfere in cardioprotection.

ABSTRACT: WEST POINT, PA -- March 27, 2000 -- Merck & Co., Inc. informed its investigators of a preliminary analysis from a large gastrointestinal (GI) outcomes study that compared Vioxx® (rofecoxib) with naproxen in patients with rheumatoid arthritis. Among patients treated with Vioxx, there was a significantly reduced incidence of serious gastrointestinal events compared to patients treated with naproxen. Merck plans to submit the information to the U.S. Food and Drug Administration (FDA) and other regulatory agencies worldwide in the next few months.

In addition, significantly fewer thromboembolic (associated with the blocking of a blood vessel by a particle that has broken away from a blood clot) events were observed in patients taking naproxen in this GI outcomes study, which is consistent with naproxen's ability to block platelet aggregation. This effect on these events had not been observed previously in any clinical studies for naproxen. Vioxx, like all COX-2 (the enzyme that triggers pain and inflammation) selective medicines, does not block platelet aggregation and therefore would not be expected to have similar effects. As a result, Merck is notifying investigators, who are conducting other Merck studies with Vioxx or another investigational medicine in the same class, of protocol amendments to allow the addition of low-dose aspirin where appropriate. Patients using low-dose aspirin, which also blocks platelet aggregation, were excluded from the GI outcomes study. Vioxx does not interfere with the ability of low-dose aspirin to block platelet aggregation.

The completed study, called VIGOR (Vioxx Gastrointestinal Outcomes Research), compared the GI safety of Vioxx (50 mg once daily) to prescription- strength naproxen (500 mg twice a day) in approximately 8,000 patients with rheumatoid arthritis. The study specifically assessed the incidence of certain types of clinically significant upper GI events, including perforations, ulcers, obstructions and bleeds. Naproxen is a commonly used non-steroidal anti-inflammatory drug (NSAID) indicated for the treatment of a number of arthritic diseases, including rheumatoid arthritis. Vioxx is not approved for the treatment of rheumatoid arthritis, nor is an application for this use under review. Vioxx is approved in the U.S. for the relief of the signs and symptoms of osteoarthritis, management of acute pain in adults and treatment of menstrual pain.
Researchers believe that NSAIDs work by inhibiting two related enzymes: COX-1, the enzyme that helps maintain the stomach lining and promotes platelet aggregation, and COX-2, the enzyme that triggers pain and inflammation. At therapeutic doses, Vioxx works by selectively inhibiting COX-2 without inhibiting COX-1; non-selective NSAIDs like naproxen inhibit both COX-1 and COX-2. Medicines like aspirin and naproxen that significantly inhibit COX-1 block platelet aggregation and therefore have the potential to provide cardioprotection.
An extensive review of safety data from all other completed and ongoing clinical trials, as well as the post-marketing experience with Vioxx, showed no indication of a difference in the incidence of thromboembolic events between Vioxx, placebo and comparator NSAIDs.
Further analyses are ongoing, and final results of the GI outcomes study with Vioxx will be presented at peer-reviewed medical meetings this year.

Source: Merck & Co., Inc.



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