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Vioxx (Rofecoxib) For Rheumatoid Arthritis Reduces Risk Of Serious Gastrointestinal Side Effects TORONTO, ON -- November 23, 2000 -- Results from one of the largest gastrointestinal (GI) studies ever conducted among rheumatoid arthritis (RA) patients was published in the November 23, 2000 issue of the highly prestigious The New England Journal of Medicine. Definitive findings showed that Vioxx® (rofecoxib) reduced the risk of symptomatic ulcers and complicated GI events (ulcers, perforations, obstructions and bleeding in the upper GI tract) by 50 percent compared to naproxen. In addition, rofecoxib reduced the risk of serious, or complicated, GI events by 60 percent (including the risk of gastrointestinal bleeding) compared to naproxen. With the publication of the landmark VIGOR (Vioxx Gastrointestinal Outcomes Research) study, results were presented today by Dr. Claire Bombardier, Chairperson of the VIGOR study steering committee and Professor of Medicine, University of Toronto, Director, Health Care Research Division Arthritis & Autoimmunity Research Center (AARC), University Health Network and rheumatologist at Mount Sinai Hospital, Toronto. "Physicians treating patients with rheumatoid arthritis have long been aware of the risk of serious side effects associated with traditional non steroidal anti-inflammatory drugs (NSAIDs)," said Dr. Bombardier. "We now have definitive evidence from a large, randomized, controlled clinical trial with very strong results showing that Vioxx not only reduced ulcers - but also reduced the incidence of serious gastrointestinal bleeding by 60 percent. Vioxx offers a better tolerated alternative to traditional NSAIDs with equivalent efficacy." The VIGOR study, a randomized, double-blind outcomes trial, involved 8,076 patients with RA in 22 countries - including 18 sites in Canada. It was conducted between January 1999 and March 2000 with most patients remaining in the study for more than nine months and some participating for as long as 13 months. Patients enrolled in the study were all diagnosed with rheumatoid arthritis and had required NSAIDs for at least one year. While rofecoxib is not indicated in Canada to treat RA, the study was conducted in this population because RA patients have a higher risk for GI side effects, making this a particularly rigorous test of the new medication's gastrointestinal safety. Patients in the study were treated with rofecoxib 50 mg once daily (two-to-four times higher than the recommended daily dose for chronic use in osteoarthritis) or with a typical daily dose naproxen 500 mg twice daily. Naproxen, a non-steroidal anti-inflammatory drug (NSAID), is currently one of the most commonly prescribed medications used to relieve the pain and inflammation due to arthritis. The clinical study called VIGOR is considered by experts to be of critical importance because the potentially devastating side effects of traditional arthritis medications, or NSAIDs, can occur at any time during the course of treatment - even within the first few days. While some patients are at increased risk for these potentially life-threatening consequences of NSAID treatment, perforations, ulcers, obstructions and bleeds can - and do - occur without warning in patients not considered to be at risk. Developing a medicine that can provide as effective pain relief as traditional NSAIDs - but with less serious gastrointestinal side effects that are frequently associated with these medications - has long been an important goal of pharmaceutical research. "This is important news for Canadians who are affected by arthritis. Although NSAIDs are among the most commonly used medications in the world, they can be associated with serious GI toxicity," indicated Dr. Monique Camerlain, rheumatologist, Centre universitaire de santé de l'Estrie, Sherbrooke, Quebec. "In my clinical experience, rofecoxib has proven to be effective and well tolerated by a wide range of my patients - including those who tend to be more difficult to treat such as the frail and elderly patients or those taking other medications because of other medical conditions." A further sub analysis of the VIGOR study, which is published in The New England Journal of Medicine, shows that the relative possibility of GI events is significantly lower with rofecoxib than with naproxen, not only in patients at high risk for GI events but also for those at low risk as well. The analysis, based on the 13-month duration of the study, showed that: - Primary endpoint - rofecoxib reduced the risk of symptomatic ulcers and complicated GI events (ulcers, perforations, obstructions and bleeding in the upper GI tract) by 50 percent (p< 0.001) compared to naproxen. - Secondary endpoint - rofecoxib reduced the risk of complicated GI events (perforations, obstructions and bleeding in the upper GI tract) by 60 percent (p=0.005) compared to naproxen. - Other pre-specified analyses of the study showed that rofecoxib reduced internal bleeding from the GI tract by 60 percent (p<0.001), with 3.0 percent of patients on naproxen experiencing bleeding compared to 1.2 percent of patients taking rofecoxib. - Significant reductions in risk for serious GI side effects and distress symptoms with rofecoxib were seen at four weeks and were maintained throughout the entire duration of the study. - Reduction in GI events was seen in all patient groups, including patients considered to be at higher risk because of individual risk factors such as age, prior history of a GI side effect, use of steroids and H. pylori. Although not designed as an efficacy study, patients and physicians were also asked to evaluate the effect of therapy on the symptoms of rheumatoid arthritis. Physicians' and patients' evaluations of the efficacy of the medicines were similar, and the rates of discontinuation due to lack of efficacy were low in both treatment groups (6.3 percent among patients taking rofecoxib and 6.5 percent among patients taking naproxen). Overall, rofecoxib was well tolerated in this study. The most common reasons for discontinuation from the study were dyspepsia, abdominal pain, upper abdominal pain, nausea and heartburn. There were significantly fewer discontinuations for these side effects among patients taking rofecoxib compared to patients taking naproxen. Cardiovascular events are more common among patients with RA than with patients who have other forms of arthritis. As previously reported, significantly fewer heart attacks were seen in patients taking naproxen (0.1 percent) compared to the group taking rofecoxib (0.4 percent) in this study, which is consistent with naproxen's ability to block platelet aggregation by inhibiting cyclooxygenase-1. This effect on platelet aggregation is similar to that of low-dose aspirin, which is used to prevent second cardiac events in patients with a history of heart attack, stroke or other cardiac events. In this study, there was no difference in cardiovascular mortality or the incidence of strokes between the groups treated with rofecoxib or naproxen. Patients taking low-dose aspirin did not participate in VIGOR. A sub analysis of the VIGOR study compared rofecoxib and naproxen for the rates of usage of GI protective agents (drugs prescribed by physicians to help protect the patients' stomach), GI diagnostic procedures and hospitalizations due to complicated GI events. Patients treated with rofecoxib were hospitalized less often than naproxen for complicated GI events, had fewer GI procedures and required fewer GI protective agents. "In order to help reduce the risk of serious adverse effects for patients at risk of GI complications, most physicians tend to use GI protective agents, in addition to traditional NSAIDs," said Dr. Jacques Courville, Vice-President, Medical Research for Merck Frosst Canada & Co. "A recent Canadian study showed that for every dollar spent on traditional NSAIDs at least ninety-two cents are spent on prevention or treatment of GI side effects," he added. Rofecoxib, which was discovered in Canada, is now approved in more than 65 countries for the relief of the signs and symptoms of osteoarthritis. In some countries, including Canada, rofecoxib is also approved for management of acute pain in adults and treatment of menstrual pain. The recommended starting 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, the maximum recommended dose for osteoarthritis. In rare cases, stomach problems can occur without warning symptoms. In case of an unexpected reaction, the patient should contact his or her doctor. People who have had an allergic reaction, to rofecoxib, aspirin or other arthritis medicines should not take rofecoxib. - Rheumatoid arthritis, is the most severe form of arthritis, which affects close to 300,000 Canadians, or one person in 100. - Over four million Canadians are currently diagnosed with arthritis, the leading cause of long-term disability in Canada. - Osteoarthritis is by far the most common form of arthritis affecting one in ten Canadians. - Approximately 10 million NSAID prescriptions are written each year in Canada. - It is estimated that between two and four percent of NSAID users suffer chronic or severe gastrointestinal problems including ulcers, stomach perforations and bleeds - some 38 to 40 percent of elderly patients use NSAIDs to treat osteoarthritis. - Arthritis is the most common cause of long-term disability in the country accounting for more than 25 percent of all long-term disability cases. - According to The Arthritis Society, estimated costs for arthritis are $17.8 billion annually to the Canadian health care system. With the aging of our population, the number of Canadians with arthritis will rise by one million per decade and the costs associated with arthritis are expected to escalate. Related Links: Vioxx® (rofecoxib) and The New England Journal of Medicine. E-mail this page to a friend or colleague! To print, use this version