CORRECTING and REPLACING ARCOXIA Significantly Reduced the Risk of Upper Gastrointestinal Side Effects Compared to Three Other NSAIDs, Data Presented at EULAR Congress Show.Business Editors/Health/Medical Writers CORRECTION by...Merck & Co., Inc. BERLIN--(BUSINESS WIRE)--June 11, 2004 In BW5352 issued June 11, 2004: Second graph should read: "In this analysis, ARCOXIA reduced a patient's risk of having an upper GI event by 50 percent...(sted "In this analysis, ARCOXIA reduced a patient's risk of having an upper GI event by 40 percent...). The corrected release reads: ARCOXIA SIGNIFICANTLY REDUCED THE RISK OF UPPER GASTROINTESTINAL SIDE EFFECTS Side effects Effects of a proposed project on other parts of the firm. COMPARED TO THREE OTHER NSAIDS, DATA PRESENTED AT EULAR CONGRESS SHOW ARCOXIA(TM) (etoricoxib) significantly reduced the risk of upper gastrointestinal (GI) side effects, such as stomach ulcers and bleeding, by half compared to three commonly prescribed non-steroidal anti-inflammatory drugs Non-steroidal anti-inflammatory drugs (NSAIDs) Aspirin, ibuprofen, naproxen, and many others. Mentioned in: Mastocytosis (NSAIDs), according to an analysis of 10 studies presented today at the annual congress of the European League Against Rheumatism rheumatism (r  `mətĭzəm), general term for a number of disorders that cause inflammation and pain in muscles, bones, joints, or nerves. (EULAR). ARCOXIA is the investigational COX-2 specific inhibitor for arthritis and pain from Merck & Co., Inc. of Whitehouse Station, N.J., U.S.A. "In this analysis, ARCOXIA reduced a patient's risk of having an upper GI event by 50 percent compared to treatment with other NSAIDs," said Alise Reicin, M.D., vice president, clinical research, Merck Research Laboratories. Study design The analysis combined the results of 10 clinical studies (Phase II/III) for ARCOXIA in 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 rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. and 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 analysis compared GI safety between the combined group of 3,226 patients taking ARCOXIA (60, 90 or 120 mg once-daily, or sequences thereof) to the combined group of 2,215 patients taking 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. 1,000 mg, diclofenac 150 mg or ibuprofen ibuprofen (ī`by prō'fən), nonsteroidal anti-inflammatory drug (NSAID) that reduces pain, fever, and inflammation. 2,400 mg daily. The analysis assessed the incidence of upper GI events collectively referred to as "PUBs": perforations in the upper GI tract, symptomatic gastroduodenal gas·tro·du·o·de·nal adj. Relating to the stomach and the duodenum. gastroduodenal pertaining to the stomach and duodenum. ulcers and bleeding in the upper GI tract. The primary endpoint of the analysis was PUBs confirmed by an independent adjudication The legal process of resolving a dispute. The formal giving or pronouncing of a judgment or decree in a court proceeding; also the judgment or decision given. The entry of a decree by a court in respect to the parties in a case. committee, and the secondary endpoint was all investigator-reported PUBs. Confirmed complicated PUBs, a subset of PUBs that includes perforations, obstructions and more severe upper GI bleeding, were included as an exploratory endpoint in the analysis. The analysis included all PUBs occurring during active treatment periods or within 14 days of stopping treatment. Because the 10 studies combined in the analysis ranged in length from six to 190 weeks, the results are expressed as the number of events per 100 patients per year(1). ARCOXIA reduced the risk of confirmed PUBs by 52 percent In the analysis, ARCOXIA significantly reduced the incidence of confirmed PUBs compared to the comparator comparator Instrument for comparing something with a similar thing or with a standard measure, in particular to measure small displacements in mechanical devices. In astronomy, the blink comparator is used to examine photographic plates for signs of moving bodies. NSAIDs. There were 2.47 confirmed PUBs per 100 patients per year for patients taking NSAIDs vs. 1.00 confirmed PUBs for patients taking ARCOXIA, for a risk reduction of 52 percent (p less than 0.001). Overall, 55 of the 2,215 patients taking NSAIDs experienced a confirmed PUB, compared to 40 of the 3,226 patients taking ARCOXIA. ARCOXIA also significantly reduced the incidence of investigator-reported PUBs compared to the comparator NSAIDs. There were 2.88 investigator-reported PUBs per 100 patients per year for patients taking NSAIDs vs. 1.17 investigator-reported PUBs for patients taking ARCOXIA, for a risk reduction of 51 percent (p less than 0.001). Overall, 64 of the 2,215 patients taking NSAIDs experienced an investigator-reported PUB, compared to 47 of the 3,226 patients taking ARCOXIA. On the exploratory endpoint of confirmed complicated PUBs, fewer complicated PUBs were observed in the group taking ARCOXIA compared to the other NSAIDs studied (p=0.09). Although the magnitude of the risk reduction for confirmed complicated PUBs was consistent with what was observed for confirmed PUBs (primary endpoint), the estimate for the exploratory endpoint is less precise due to a smaller number of these events. Efficacy data for ARCOXIA also presented at congress Data from efficacy studies evaluating ARCOXIA vs. naproxen in the treatment of ankylosing spondylitis and ARCOXIA vs. indomethacin indomethacin /in·do·meth·a·cin/ (in?do-meth´ah-sin) a nonsteroidal antiinflammatory drug; used in the treatment of various rheumatic and nonrheumatic inflammatory conditions, dysmenorrhea, and vascular headache. in the treatment of 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 also were presented today at the annual congress of the EULAR. About ARCOXIA and Merck The Food and Drug Administration currently is reviewing Merck's New Drug Application for ARCOXIA, which seeks indications for the treatment of osteoarthritis, rheumatoid arthritis, chronic low back 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 and ankylosing spondylitis. ARCOXIA has been launched in 45 countries worldwide in Europe, Latin American and the Asia-Pacific region. Merck & Co., Inc. is a global research-driven pharmaceutical products 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. FORWARD-LOOKING STATEMENT: 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. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development. 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 press release 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, 2003, and in our periodic reports on Form 10-Q and Form 8-K (if any) which Merck incorporates by reference. (1) The analyses are expressed on a per 100-patient year basis, which is calculated by taking the total number of PUBs for a given treatment group and dividing it by the total duration of time that patients in that treatment group participated in the studies. ARCOXIA(TM) is a trademark of Merck & Co., Inc. |
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