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Investigational Drug Effective and Well-Tolerated For Osteoarthritis Pain

  [ 2 votes ]   [ 8 Comments ]
By News Release • www.ProHealth.com • January 23, 2000


BOSTON, MA -- An investigational medicine being developed by Merck & Co., Inc. significantly relieved more pain in patients with osteoarthritis of the knee than did placebo, according to a dose-ranging study presented by researchers at the annual meeting of the American College of Rheumatology.

"Patients treated with MK-663 had less walking pain or pain going up or down stairs or were awakened at night by pain less often than patients on placebo," says Dr. Thomas J. Schnitzer, professor and director, office of Clinical Research and Training, Northwestern University and a study investigator. "We also saw that patients on MK-663 had less difficulty doing simple everyday activities, such as getting out of bed, bending down to hug a child, getting in and out of a car, going grocery shopping, or dressing." MK-663 is an investigational medicine being developed by Merck that is designed to specifically inhibit the cyclooxygenase-2 (COX-2) enzyme.

In the multi-center, six-week study, 617 patients with osteoarthritis of the knee were randomized to MK-663 at 5 mg (117 patients), 10 mg (114 patients), 30 mg (102 patients), 60 mg (112 patients), 90 mg (112 patents) or placebo (60 patients) given once a day, after experiencing pain flare-up following withdrawal from treatment with non-steroidal anti-inflammatory drugs (NSAIDs). Efficacy and tolerability of MK-663 were evaluated at one, two, four and six weeks of therapy. At all doses studied, patients on MK-663 reported less pain compared to placebo (measured by the Western Ontario McMaster Osteoarthritis Questionnaire -- WOMAC), a validated measure of osteoarthritis symptoms).
Specific improvements with MK-663 included:
-- relief of pain including walking, stair climbing and night pain (WOMAC Questions 1-5, VAS, 0-100 mm);
-- overall patient assessment of response to therapy (Likert scale, 0-4 or "none" to "excellent"); and
-- physician's assessment of the patient's disease status (Likert scale).
Pain relief was measurable within the first week of treatment with MK-663, and sustained through the six-week study period. A dose response was observed. The 30 mg dose was superior to 5 mg and 10 mg. The 30 mg dose showed about half the effect of the 60 mg and 90 mg doses. The effect of those doses were similar.

Treatment with MK-663 was generally well-tolerated across the entire dose range in the study. The most commonly reported side effects for both MK-663 and placebo were diarrhea, nausea and headache. Few patients discontinued due to adverse events.

COX-2 triggers pain and inflammation, while another related enzyme, COX-1, helps maintain the normal stomach lining. Non-selective NSAIDs inhibit both COX-1 and COX-2, which can result in serious gastrointestinal side effects. In laboratory and clinical studies, MK-663 at doses up to 150 mg did not inhibit the COX-1 enzyme while significantly inhibiting the COX-2 enzyme.

Source: Merck & Co., Inc.



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