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Back To Vidyya First Study Evaluating The Efficacy And Tolerability Of Vioxx®, Celecoxib And Acetaminophen For Osteoarthritis Presented


Presented At The American College of Rheumatology Annual Meeting

In a new study, Vioxx® 25 mg (rofecoxib), the prescription osteoarthritis medicine developed and marketed by Merck & Co., Inc., reduced osteoarthritis pain at night and at rest to a greater degree than celecoxib 200 mg and acetaminophen 4,000 mg. Results of the study were reported yesterday at the annual meeting of the European League Against Rheumatism, the largest rheumatology conference in Europe.

"Vioxx and celecoxib are both approved for the treatment of osteoarthritis, the most common form of arthritis. This new study is the first to assess the efficacy and tolerability of both medicines in patients with this painful condition," said Gregory Geba, M.D., director, clinical development, Merck & Co., Inc. "A larger study comparing Vioxx and celecoxib in the management of osteoarthritis is underway."

The 382 patients participating in the six-week, multi-center pilot study were randomized to four treatment arms: Vioxx 12.5 mg once-daily (n=96), Vioxx 25 mg once-daily (n=95), celecoxib 200 mg once-daily (n=97) and acetaminophen 1,000 mg four-times daily (n=94). All patients had symptomatic osteoarthritis of the knee. The average age of patients was 63.

In this study, patient response to treatment was evaluated using standard osteoarthritis measures: a self-administered patient questionnaire known as the WOMAC Index and the Patient and Investigator Global Assessment of Response to Therapy scale. Patients' responses were assessed on the first six days of therapy and after two, four and six weeks of treatment. Statistical analyses were conducted to compare the average response to the four treatment arms over the six-week duration of the study.

On the measures that evaluated the average response to treatment over the six weeks of the study, the statistically significant (p<0.05) differences included:

  • -- Vioxx 25 mg was superior to Vioxx 12.5 mg, celecoxib 200 mg and acetaminophen 4,000 mg at relieving pain at night; patients taking Vioxx 25 mg experienced an average reduction of 32.7 mm on the WOMAC Index(1) versus an average reduction of 22.6 mm among celecoxib patients and an average reduction of 23.6 mm among acetaminophen patients.
  • -- Vioxx 25 mg was superior to celecoxib 200 mg and acetaminophen 4,000 mg at relieving pain at rest; patients taking Vioxx 25 mg experienced an average reduction of 31.1 mm on the WOMAC Index versus an average reduction of 23.4 mm among celecoxib patients and an average reduction of 21.7 mm among acetaminophen patients.

    Similar results were reported on the measures that assessed early efficacy (the first six days of therapy) with Vioxx 25 mg, celecoxib 200 mg and acetaminophen 4,000 mg.

    In addition, significantly more patients taking Vioxx 25 mg daily reported a good or excellent response to treatment at six weeks than patients taking celecoxib 200 mg or acetaminophen 4,000 mg; 60.2 percent of patients taking Vioxx 25 mg reported a good or excellent response to therapy at week six versus 45.7 percent of patients taking celecoxib and 39.1 percent of patients taking acetaminophen.

    Vioxx 12.5 mg and celecoxib 200 mg were not statistically different from each other on any measure in early efficacy or at six weeks.

    All treatments studied were generally safe and well-tolerated. There were no significant differences in the incidence of any clinical adverse events between the groups.

    Vioxx, a prescription medicine that selectively inhibits the COX-2 enzyme, is approved in the United States for the relief of the signs and symptoms of osteoarthritis, management of acute pain in adults and treatment of menstrual pain. Celecoxib also selectively inhibits COX-2. Acetaminophen is a widely used pain reliever.

    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.

    Serious stomach problems, such as bleeding, can occur without warning symptoms. Physicians and patients should remain alert for signs and symptoms of gastrointestinal bleeding.

    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. Common side effects reported in other clinical trials with Vioxx were upper-respiratory infection, diarrhea, nausea and high blood pressure.


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Editor: Susan K. Boyer, RN
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