RIDGEFIELD, Conn., Aug. 22 /PRNewswire/ -- Results from a pooled analysis of 35 clinical trials with 27,039 patients, of whom 15,071 were taking the nonsteroidal anti-inflammatory drug (NSAID) MOBIC® (meloxicam) at the recommended starting dose of 7.5mg daily, demonstrate that rates of cardiovascular adverse events were low and similar for MOBIC and two other commonly prescribed NSAIDs.¹ These clinical trials were not specifically designed to examine cardiovascular safety of MOBIC. The pooled retrospective analysis was based on cardiovascular data collected through routine monitoring. 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). To date, there have been no head-to-head comparisons between MOBIC, Celebrex and Vioxx. 

"This large analysis reveals no increased risk of cardiovascular events among patients taking MOBIC," said Gurkirpal Singh, MD, Senior Research Scholar and Clinical Assistant Professor of Medicine Immunology and Rheumatology, Stanford University Medical School. 

The findings, which will be presented later this year at the annual meeting of the American College of Rheumatology, are especially important in light of the medical community's concern about the cardiovascular side effects of NSAIDs. An article published this week in the Journal of the American Medical Association examined the risk of cardiovascular events associated with nonsteroidal anti-inflammatory drugs, including Celebrex and Vioxx.

"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," added Dr. Singh.

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 and piroxicam 20mg daily.²

Available in the U.S. since April 2000, MOBIC has been used by more than 45 million patients in 100 countries³ and costs about 20 percent less than Celebrex and Vioxx.

There are risks involved with the use of NSAIDs, and both physicians and patients are encouraged to assess these risks with the benefits of NSAID therapy on an individual basis.

The most common gastrointestinal (GI) adverse 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.

MOBIC was developed by Boehringer Ingelheim and is co-marketed with Abbott Laboratories. For more information, including full prescribing information, please visit http://www.MOBICtablet.com/.

About Boehringer Ingelheim

The Boehringer Ingelheim group of companies ("Boehringer Ingelheim"), with headquarters in Ingelheim (Germany) is one of the 20 leading pharmaceutical firms in the world and reported revenues of almost US $5.4 billion in 1999.

Boehringer Ingelheim has worldwide some 140 affiliated companies. The focus is on the human pharmaceutical as well as on the animal health business. The human pharmaceutical business, which is responsible for 92% of sales, includes mainly ethical pharmaceuticals and consumer healthcare but also products for industrial customers (chemicals and biopharmaceuticals).

For more information, please visit http://www.boehringer-ingelheim.com/.

* CELEBREX is a registered trademark of Pharmacia Corporation

** VIOXX is a registered trademark of Merck & Company, Inc.

¹ 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.

² Data on file, Boehringer Ingelheim Pharmaceuticals, Inc.

³ Dequeker J, Degner F. Meloxicam: "New formulations and their use in rheumatology." Editorial Inflammation Research 50; 2001:S3-S4

SOURCE: Boehringer Ingelheim

WEB SITE: http://www.boehringer-ingelheim.com/

WEB SITE: http://www.MOBICtablet.com/

CO: Boehringer Ingelheim; Abbott Laboratories