ARCOXIA Demonstrated Superior Results Versus Placebo in the Treatment of Ankylosing Spondylitis, a Highly Painful, Inflammatory Disease, in the Primary Efficacy Analysis of a New Study.Business Editors/Health & Pharmaceutical Writers NEW ORLEANS--(BUSINESS WIRE)--Oct. 28, 2002 ARCOXIA Also Showed Superior Treatment Effects Over the Non-Steroidal Anti-inflammatory Drug Non-steroidal anti-inflammatory drugs, usually abbreviated to NSAIDs, are drugs with analgesic, antipyretic and anti-inflammatory effects - they reduce pain, fever and inflammation. (NSAID NSAID: see nonsteroidal anti-inflammatory drug. ) Naproxen naproxen and naproxen sodium, potent nonsteroidal anti-inflammatory drugs (NSAID) used to alleviate the minor pain of arthritis, menstruation, headaches, and the like, and to reduce fever. In the primary efficacy analysis of a new study, ARCOXIA(TM) (etoricoxib) demonstrated superior results versus placebo in treating patients with ankylosing spondylitis Ankylosing Spondylitis Definition Ankylosing spondylitis (AS) refers to inflammation of the joints in the spine. AS is also known as rheumatoid spondylitis or Marie-Strümpell disease (among other names). . The study showed the combined group of patients taking ARCOXIA 90 mg or 120 mg once daily demonstrated significant improvements on the primary measurements of pain, function and global assessments at six weeks versus placebo. A significant difference in efficacy between the patients taking ARCOXIA and patients taking naproxen 500 mg twice daily also was seen at six weeks. Researchers presented the results of the new study at the 66th annual scientific meeting of the American College of Rheumatology rheumatology /rheu·ma·tol·o·gy/ (-tol´ah-je) the branch of medicine dealing with rheumatic disorders, their causes, pathology, diagnosis, treatment, etc. rheu·ma·tol·o·gy n. here today. ARCOXIA is Merck & Co., Inc.'s investigational medicine for arthritis and pain. "In this study, patients treated with ARCOXIA experienced significant improvements in several types of measurements, including pain, inflammation, global assessments, function and mobility compared to those treated with placebo or naproxen," said Agustin Melian, director of clinical research, Merck & Co., Inc. "This is the first time a COX-2 inhibitor showed statistically significant improvements over a non-selective NSAID in treating this highly inflammatory disease." The randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , controlled, double-blind study included 387 patients with a diagnosis of ankylosing spondylitis per Modified New York Criteria(1) and also sufficient "flare"(2). Patients were randomized to ARCOXIA 90 mg (n=103), ARCOXIA 120 mg (n=92), naproxen 500 mg twice daily (n=99) or placebo (n=93) after withdrawal from pre-study medication. ARCOXIA demonstrated superior improvements across multiple endpoints On all primary endpoints (Patient Global Assessment of Spine Pain, Patient Global Assessment of Disease Activity and Bath AS Functional Index), the combined group of patients taking ARCOXIA showed significantly greater improvements in comparison to placebo (p<0.001). Consistent findings also were seen with ARCOXIA versus naproxen (p<0.05). The naproxen group showed significantly greater treatment effects than placebo (p<0.05), but not as great as the combined group of patients taking ARCOXIA versus placebo (p<0.001). There was no significant difference in treatment effects between ARCOXIA 90 mg and 120 mg. Results were based on the average response of patients across pre-specified time periods (weeks two, four and six).
-- Patient Global Assessment of Spine Pain: In this study, the combined group of patients taking ARCOXIA reported, on average, a 29 mm decrease in spine pain from baseline compared to placebo, while the naproxen group reported a 21 mm average reduction compared to placebo as measured by the visual analog scale (0-100 mm where 0 = "none" and 100 = "severe").
-- Patient Global Assessment of Disease Activity: With a visual analog scale of 0 ("very well") to 100 ("very poor"), patients taking ARCOXIA experienced a 24 mm average decrease in disease activity from baseline compared to placebo. The naproxen group experienced, on average, an 18 mm reduction in disease activity compared to placebo.
-- Bath AS Functional Index: The pooled group of patients taking ARCOXIA reported a 15 mm average decrease from baseline compared to placebo, and the naproxen group reported a 11 mm average reduction from baseline compared to placebo. A visual analog scale was used where 0 represented "easy" and 100 represented "impossible".
-- The results of all secondary and exploratory endpoints were generally consistent with the primary findings.
ARCOXIA generally well tolerated in the study In the six-week study, ARCOXIA and naproxen were generally well tolerated. The incidence of drug-related adverse experiences, GI nuisance symptoms and hypertension- and edema-related adverse experiences were similar among the three active treatment groups. The safety profile of ARCOXIA 90 mg and 120 mg were generally similar. The most common drug-related adverse effects in the study included abdominal pain, hypertension, diarrhea, dyspepsia dyspepsia: see indigestion. , epigastric epigastric adjective Referring to the body region between the costal margins and the subcostal plane discomfort, heartburn heartburn, burning sensation beneath the breastbone, also called pyrosis. Heartburn does not indicate heart malfunction but results from nervous tension or overindulgence in food or drink. , nausea and headache. About ankylosing spondylitis Ankylosing spondylitis is a chronic, autoimmune disease that primarily affects the spine, usually leading to pain, stiffness and immobility of the lower back. The typical sufferers of ankylosing spondylitis are men, and the age of onset The age of onset is a medical term referring to the age at which an individual acquires, develops, or first experiences a condition or symptoms of a disease or disorder. Diseases are often categorized by their ages of onset as congenital, infantile, juvenile, or adult. is usually between ages 16 and 35. Although the cause of the disease is unknown, genetics appears to play a role.(3) About ARCOXIA and Merck ARCOXIA is currently being studied for a range of indications, including osteoarthritis osteoarthritis or osteoarthrosis or degenerative joint disease Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. , rheumatoid arthritis, chronic pain, acute pain, dysmenorrhea dysmenorrhea Pain or cramps before or during menstruation. In primary dysmenorrhea, caused by endocrine imbalances, severity varies widely. Irritability, fatigue, backache, or nausea may also occur. (menstrual pain), acute gouty arthritis acute gouty arthritis Acute gout Rheumatology An abrupt gouty attack, which may be precipitated by overeating, alcohol, surgery, emotional stress, infection, antibiotics, insulin Clinical Crushing pain of a joint–most often the great toe–which is and ankylosing spondylitis. Merck & Co., Inc. is a leading 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 Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. We undertake 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 our business, particularly those mentioned in the cautionary statements in Item 1 of our Form 10-K for the year ended Dec. 31, 2001, and in our periodic reports on Form 10-Q and Form 8-K (if any) which we incorporate by reference. (1) Van der Linden, S, Valkenburg, HA, Cats, A. "Evaluation of diagnostic criteria for ankylosing spondylitis." Arthritis and Rheumatism rheumatism (r  `mətĭzəm), general term for a number of disorders that cause inflammation and pain in muscles, bones, joints, or nerves. . 1984; 27: 361-368.(2) Defined as =>40 mm and an increase of at least 12 mm on Patient Assessment of Spine Pain (0-100 mm VAS vas (vas) pl. va´ sa [L.] vessel.va´sal vas aber´rans 1. a blind tubule sometimes connected with the epididymis; a vestigial mesonephric tubule. 2. where 0 = "None" and 100 = "Severe") (3) Arthritis Foundation, www.arthritis.org ARCOXIA(TM)is a trademark of Merck & Co., Inc. |
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