To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ECR: Osteoarthritis Drug, Mobic (Meloxicam), Demonstrates Favorable Gastrointestinal/Cardiovascular Safety Profile URL: http://www.pslgroup.com/dg/1FC70E.htm Doctor's Guide May 25, 2001
RIDGEFIELD, CT -- May 25, 2001 -- New findings from a pooled analysis of 35 clinical trials with 27,039 patients, of whom 10,158 were taking the nonsteroidal anti-inflammatory drug (NSAID) Mobic® (meloxicam) at the recommended starting dose of 7.5mg daily, demonstrate that Mobic has a favorable gastrointestinal (GI) tolerability profile and a low incidence of adverse GI events.(1) Mobic is indicated for the relief of the signs and symptoms of osteoarthritis and is the third NSAID approved by the Food and Drug Administration (FDA) in the past two years after Celebrex® (celecoxib) and Vioxx® (rofecoxib). Efficacy and safety of Mobic are further supported by an extensive clinical trial database of more than 32,000 patients. Also important to note, in these 35 trials, rates of cardiovascular adverse events were low and similar for Mobic and two other commonly prescribed NSAIDs.(2) Abstracts on these study findings will be presented during the Annual European Congress of Rheumatology on June 13-16, 2001 in Prague, Czech Republic. These safety findings are especially important in light of the medical community's concern about GI and cardiovascular side effects of NSAIDs. There are approximately 107,000 hospitalizations each year in the US from serious NSAID-induced GI side effects (such as GI bleeds, or stomach ulcers) - with annual hospital costs exceeding $1 billion.(3) Likewise, many osteoarthritis patients are older than 65, and many of these patients suffer from co-morbid conditions including cardiovascular disease. Therefore, when choosing a medication to treat osteoarthritis, it is important to strike a balance between efficacy and overall safety. Clinical trials also demonstrate that Mobic 7.5mg daily and 15mg daily were comparable in efficacy to the commonly prescribed NSAIDs, diclofenac SR 100mg daily(4) and piroxicam 20mg daily. Mobic, available in the US since April 2000, has been used by more than 30 million patients in 100 countries. Mobic offers a balance between reliable efficacy and overall safety at a cost of about 20 percent less than Celebrex and Vioxx. Given the chronic nature of osteoarthritis, the benefit of this long-term savings can be felt by both physicians and patients. The most common adverse GI effects associated with Mobic are diarrhea, dyspepsia and nausea. As with other NSAIDs, Mobic is not indicated for prevention of thromboembolic events and is not a substitute for aspirin or other drugs indicated for cardiovascular prophylaxis. Mobic is contraindicated in patients who have experienced asthma, itching or allergic type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. As with all NSAIDs, serious GI toxicity such as inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine can occur at any time, with or without symptoms. References: (1) Singh G, Triadafilopoulos. "Meloxicam has a low risk of serious gastrointestinal complications: pooled analysis of 27,039 patients." Abstract to be presented at the Annual European Congress of Rheumatology, June 13-16, 2001, Prague, Czech Republic. (2) Singh G, "Meloxicam does not increase the risk of acute myocardial infarction, congestive heart failure, edema or hypertension compared to NSAIDS: results from a pooled analysis of 27,039 patients." Abstract to be presented at the Annual European Congress of Rheumatology, June 13-16, 2001, Prague, Czech Republic. (3) Singh G, NSAID-Induced GI Complications: The ARAMIS Perspective - 1997, J Rheumatology, 25: 8-16 Suppl. (4) Data on file, Boehringer Ingelheim Pharmaceuticals, Inc.
SOURCE: Boehringer Ingelheim
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