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| |  ACR: Osteoarthritis Patients Taking Vioxx Experience Fewer GI Complications BOSTON, MA -- November 17, 1999 -- Many patients who take non-steroidal anti-inflammatory drugs (NSAIDs) for their osteoarthritis pain also take medicines to prevent or relieve symptoms such as heartburn and nausea that can be associated with NSAIDs. In a new, retrospective, combined analysis presented at the annual meeting of the American College of Rheumatology, 42 percent fewer osteoarthritis patients treated with Vioxx(R) (rofecoxib), a new prescription medicine for osteoarthritis from Merck & Co., Inc., needed additional medications to relieve or prevent gastrointestinal (GI) symptoms compared to patients taking one of several commonly prescribed NSAIDs.
"Many patients who take medications to relieve their osteoarthritis pain must also be treated for the stomach symptoms that can be caused by taking these pain medications," says Dr. Loren Laine, professor of medicine, division of Gastrointestinal and Liver Diseases, University of Southern California, Los Angeles. "In this new analysis, patients treated with Vioxx were significantly less likely to take additional medicines to relieve the uncomfortable gastrointestinal side effects that can result from using NSAIDs." The analysis included 4921 patients who participated in eight clinical trials of Vioxx for osteoarthritis that ranged from six weeks to 12 months in duration. The patients were randomly assigned to one of three doses of Vioxx (n=3357) or to one of three commonly used NSAIDs, ibuprofen, diclofenac or nabumetone (total patients = 1564). The analysis evaluated the number of patients who used gastrointestinal medications, including antacids, H? antagonists, and proton pump inhibitors. It also evaluated how many patients underwent GI diagnostic procedures. Significantly fewer patients treated with Vioxx took stomach medications compared to patients treated with the other NSAIDs (9.1 percent compared to 15.7 percent, respectively, p<0.001). There was no significant difference between patients treated with Vioxx who underwent GI procedures compared to patients treated with the other NSAIDs (1.25 percent versus 1.98 percent, respectively, p=0.057). On May 21, 1999, the U.S. Food and Drug Administration (FDA) approved Vioxx for relief of the signs and symptoms of osteoarthritis, management of acute pain in adults and treatment of menstrual pain (primary dysmenorrhea). 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. Serious gastrointestinal ulcers or bleeding can occur with or without warning symptoms with NSAIDs. Physicians and patients should remain alert for signs and symptoms of gastrointestinal bleeding. Common side effects reported in the clinical trials with Vioxx were upper-respiratory infection, diarrhea, nausea and high blood pressure. Osteoarthritis, frequently known as the "wear-and-tear" disease, is the most common type of joint disease worldwide. In osteoarthritis, cartilage in the joints breaks down, causing pain, swelling, stiffness and decreased mobility in sufferers. More than 75 percent of all people over age 60 show signs of osteoarthritis, although a majority do not experience symptoms until after age 75. The prevalence of osteoarthritis rises steeply with age and affects more women than men.
Related Link: Merck & Co., Inc.
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