Business Editors/Health/Medical Writers
CHICAGO--(BUSINESS WIRE)--March 20, 2003
Results from a new study of patients with acute gouty arthritis demonstrated that ARCOXIA(TM) (etoricoxib) 120 mg once daily relieved the pain of acute gouty arthritis as well as indomethacin (50 mg three times daily), a standard treatment for the disease.
ARCOXIA is Merck & Co. Inc.'s investigational medicine for arthritis and pain. Researchers will present results here today at the 22nd Annual Scientific Meeting of the American Pain Society.
"Acute gouty arthritis is one of the most excruciatingly painful arthritic diseases," said Gregory Geba, M.D., study investigator and senior director of Clinical Development, Merck & Co., Inc. "In the study, ARCOXIA 120 mg once daily provided effective relief from pain and inflammation comparable with indomethacin, which has been a standard therapy for this condition for more than 30 years. In addition, ARCOXIA was generally well tolerated in this trial. Results from this large study of nearly 200 patients confirm those seen in another identically designed study of ARCOXIA." The earlier study was published in the June 2002 issue of the British Medical Journal.
This randomized, double-blind study evaluated the efficacy and safety of ARCOXIA 120 mg once daily (n=103) compared with the non-selective non-steroidal anti-inflammatory drug (NSAID) indomethacin 50 mg three times daily (n=86) in the treatment of acute gouty arthritis over a seven-day treatment period. A total of 189 patients (176 men, 13 women) with clinically diagnosed acute gouty arthritis (as defined by American Rheumatology Association criteria) participated in the study.
The primary endpoint of the study was patient assessment of joint pain over the first four full days of treatment. Secondary endpoints over seven days of treatment included investigator and patient global assessment of response to treatment, investigator assessment of joint tenderness and swelling and discontinuation from the study due to lack of drug efficacy.
Patients completed pain assessments at baseline and on each day of the study four hours after their daily dose of study medication. They were seen in the clinic for office visits on Days 1, 2, 5, 8 and 22 (14 days after the last dose of the study medication on Day 8).
ARCOXIA reduced joint pain to a similar degree as indomethacin
In the study, the benefits of ARCOXIA in treating pain were comparable to those seen with indomethacin. Specifically, results of the study showed:
-- ARCOXIA demonstrated comparable efficacy to indomethacin in
relieving joint pain over Days 2 through 5. On a scale of 0
(no pain) to 4 (extreme pain), patients treated with ARCOXIA
reported a 1.79 unit decrease in their pain level from
baseline after the first four days of treatment, while those
receiving indomethacin reported a 1.71 unit decrease in their
pain level from baseline.
-- Patients reported that ARCOXIA continued to reduce joint pain to the same degree as indomethacin over the entire seven-day treatment period.
-- Patients reported pain relief with both ARCOXIA and indomethacin as early as the first time point assessed in the study (four hours after the first dose on Day 1).
-- Fewer patients taking ARCOXIA (4.9 percent) discontinued treatment due to lack of efficacy than patients taking indomethacin (8.1 percent).
-- ARCOXIA was similar to indomethacin on all other secondary endpoint measures, including investigator assessment of joint tenderness and swelling.
ARCOXIA generally well tolerated in the study
ARCOXIA was generally well tolerated. The overall adverse event rate was numerically lower, but not statistically significant, in patients treated with ARCOXIA (43.7 percent) than in those taking indomethacin (57.0 percent). Patients treated with ARCOXIA had significantly fewer adverse events (16.5 percent) considered by investigators to be drug-related than patients taking indomethacin (37.2 percent) (p=0.002). The most common drug-related adverse events included dizziness, hypertension, nausea, headache and somnolence (sleepiness), all of which occurred more frequently with indomethacin than ARCOXIA.
Results confirm findings of previous study
An earlier, identically designed study was published in the June 2002 issue of the British Medical Journal.(1) Results showed that ARCOXIA 120 mg once daily provided a comparable degree of pain relief as indomethacin 50 mg three times daily in patients with acute gouty arthritis and was generally well tolerated in the study. These two studies are larger than any other ever conducted in patients with acute gouty arthritis.
About acute gouty arthritis
Acute gouty arthritis affects approximately 2.2 million people in the United States alone each year.(2) It is the most common form of inflammatory joint disease in men over the age of 40.
Acute gouty arthritis is associated with intense pain and inflammation that can reach peak levels within a few hours and remain at that level for several days. Acute gout is characterized by painful joint inflammation caused by metabolic imbalances that result in the overproduction of uric acid. This leads to the deposits of monosodium urate crystals in the joint fluid and joint lining, especially in the feet and legs. The inflammation associated with gouty arthritis typically causes pain, heat and redness of the joint tissue.
About ARCOXIA and Merck
ARCOXIA is currently being studied for a range of indications, including osteoarthritis, rheumatoid arthritis, chronic pain, acute pain, dysmenorrhea (menstrual pain), acute gouty arthritis and ankylosing spondylitis.
Merck & Co., Inc. is a global research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures.
This press release contains "forward-looking statements" as that term is defined in the U.S. Private Securities Litigation Reform Act of 1995. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this document should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2001, and in Merck's periodic reports on Form 10-Q and Form 8-K (if any) which are incorporated by reference.
(1)Schumacher HR, Boice JA, et al. Randomised double blind trial of etoricoxib and indometacin in treatment of acute gouty arthritis. British Medical Journal. June 2002; 324:1488-92.
(2)National Center for Health Statistics: Collins JC: Prevalence of selected chronic conditions, United States, 1979 - 1981. Vital and Health Statistics, Series 10, No. 155. DHHS Pub. No. (PHS) 86-1583. Washington, DC, U.S. Government Printing Office, 1986.
ARCOXIA(TM) is a trademark of Merck & Co., Inc.
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