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| |  ACR MEETING: Vioxx Comparable To Diclofenac, Ibuprofen In Osteoarthritis SAN DIEGO, CA -- Nov. 10, 1998 -- Vioxx™ (rofecoxib) relieved the pain and inflammation of osteoarthritis (OA) comparable to the maximum dose of diclofenac, a medicine commonly prescribed for arthritis and pain, in a one-year study in 784 patients presented today at the American College of Rheumatology annual meeting. Similar results were also presented for a six-week study with 736 patients comparing Vioxx to maximum doses of ibuprofen, a medicine commonly prescribed for arthritis and pain, taken three times a day. Also, in a pilot study of 133 patients with rheumatoid arthritis (RA), Vioxx reduced symptoms such as pain, disability and morning stiffness, compared to placebo. Vioxx is an investigational, once-a-day COX-2 specific inhibitor being developed by Merck & Co., Inc. "Vioxx relieved the pain, stiffness and joint tenderness of OA in studies lasting up to one year, and these effects were comparable to what was seen with diclofenac," said study author Grant Cannon, M.D., associate chief of staff for Academic Affiliations, Salt Lake V.A. Medical Center. "The length and scope of these studies help us evaluate the potential of Vioxx to treat the signs and symptoms of this disease." Vioxx Relieved Signs of OA Compared to Ibuprofen and Diclofenac In two separate Phase III studies, the efficacy and tolerability of Vioxx were compared to maximum doses of the traditional non-selective prescription nonsteroidal anti-inflammatory drugs (NSAIDs), diclofenac and ibuprofen, in patients with OA of the knee and hip. These patients had either experienced pain after withdrawal from treatment with an NSAID or had experienced moderate to severe pain while taking acetaminophen (1.2 g/day to 4 g/day). Efficacy was based on endpoints that assessed patients’ response to therapy, physicians’ evaluation of whether their patients’ condition had improved, and pain walking on a flat surface. Endpoints were measured using a self-administered questionnaire to assess pain, function and disability from OA in the hips and knees and patients’ overall response to treatment. The first study, conducted over 52 weeks, examined 784 patients randomized either to once-daily Vioxx (12.5 mg or 25 mg), or 50 mg diclofenac taken three times daily. In the study, pain relief for patients treated with Vioxx was comparable to maximum doses of diclofenac and the treatment results were maintained for over the one-year study period. Patients on Vioxx reported reductions in pain based on the parameters studied, reductions in joint tenderness and disability and improvements in functioning. Treatment with Vioxx was generally well tolerated. Treatment with diclofenac was also well tolerated; however more discontinuations due to adverse experiences were seen in the diclofenac group because of abnormal liver tests. In the second study, 736 patients were randomized to once-daily doses of Vioxx (12.5 mg or 25 mg), 800 mg ibuprofen taken three times daily or placebo for six weeks. At two, four and six weeks, patients in both treatment groups with Vioxx demonstrated relief from pain and inflammation comparable to patients taking high doses of ibuprofen. The active treatment groups showed significantly greater improvement in all endpoints compared with patients taking placebo. Treatment with Vioxx was generally well tolerated and similar to placebo. The most frequent adverse experiences in both studies among the treatment groups were upper respiratory infection, diarrhea, nausea and headache. The incidence of mild fluid retention was similar across all treatment groups, and the incidence of thromboembolic cardiovascular adverse experiences was low (less than one percent) and similar between Vioxx, diclofenac and ibuprofen. More than 20 million Americans have OA, which is a degenerative joint disease in which the cartilage that covers the bone ends deteriorates, causing pain, inflammation and disability.
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