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        New COX-2 Inhibitor Etoricoxib Looks Promising for Back Pain, Rheumatoid Arthritis and Acute Gouty Arthritis: Presented at Eular

        By Alison Palkhivala
        Special to DG News

        STOCKHOLM, SWEDEN -- June 17, 2002 -- The new investigational COX-2 inhibitor etoricoxib is showing promise with respect to providing relief in many painful conditions, including back pain, rheumatoid arthritis (RA), and acute gouty arthritis (AGA).

        The drug also appears to have a favorable renovascular safety profile. Several studies on etoricoxib were presented here this week at the Annual European Congress of Rheumatology (EULAR).

        In a study led by Dr. J. A. Boice from the department of clinical research at Merck & Co., Inc., Rahway, United States, 150 adults with AGA of less than 48 hours' duration were randomized to treatment with etoricoxib 120 mg daily or indomethacin 50 mg TID for eight days. Response was equally fast and effective with both drugs, according to both the patients' and the investigators' assessments of pain, tenderness, and inflammation.

        Another study, led by Dr. G. P. Geba from the clinical development department of Merck & Co in West Point, United States, compared treatment with etoricoxib 60 and 90 mg to placebo in 325 patients with chronic low back pain. After three months, patients in both etoricoxib groups reported significantly reduced pain and disability compared to placebo patients.

        Dr. S. P. Curtis, also from the department of clinical research at Merck & Co., Inc., Rahway, led another study in which 891 RA patients were randomized to treatment with etoricoxib 90 mg daily, naproxen 500 mg BID, or placebo. Among the 687 patients who completed the 12 week study, patients on etoricoxib and naproxen had significantly greater improvement than placebo patients on parameters that included counts of tender and swollen joints, patient and investigator assessment of disease activity, Stanford Health Assessment Questionnaire (HAQ) results, American College of Rheumatology (ACR) 20 response criteria, and patient assessments of pain. Both treatments were well tolerated.

        Another study with RA patients, this time led by Dr. A. Melian from the clinical immunology department at Merck & Co., Inc., Rahway, compared quality of life assessment among 816 RA patients randomized to treatment with etoricoxib 90 mg daily, naproxen 500 mg BID, or placebo for 12 weeks. The investigators used the Medical Outcomes Trust SF-36 to assess quality of life, which assesses eight quality of life domains. At the end of the study, all of these domains were improved with etoricoxib compared to placebo, and five (physical functioning, role-physical pain, general health perceptions, pain, and social functioning) were significantly improved for etoricoxib patients compared to those on naproxen.

        Dr. S. P. Curtis and colleagues evaluated the safety of renovascular safety with etoricoxib by collecting data on 3,348 patients who participated in one of eight phase III clinical trials with the drug. They found that the risk of developing low extremity edema and hypertension while taking etoricoxib was low and similar to the risks seen with other non-steroidal anti-inflammatories (NSAIDs), including naproxen and ibuprofen.

        These studies were all performed in conjunction with Merck & Co., Inc., manufacturers of etoricoxib.



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