Global discussion on COX-2 selective inhibitors highlights meloxicam's overall safety profile

Added: (Wed Jun 20 2001)

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Global discussion on COX-2 selective inhibitors highlights meloxicam's overall safety profile

Prague, Czech Republic, 14th June 2001: At a conference of more than 8,000 rheumatologists and gastroenterologists, a debate was held today to discuss the advances made in treating arthritis with selective COX-2 inhibitors. The discussion, held in conjunction with the 16th EULAR (European League Against Rheumatism) Congress, entitled: “Cox-2 inhibitors: Designer drugs or more of the same?” sponsored by Boehringer Ingelheim, aimed to examine the changing landscape of arthritis management with these new treatments.

The development of the selective cyclo-oxygenase-2 (COX-2) inhibitors, including meloxicam, celecoxib and rofecoxib has been heralded as a revolution in the treatment of rheumatic disease. Meloxicam, for example, has been used to date by over 45 million patients in more than 100 countries worldwide.

The consensus from the debate showed that with respect to gastro-intestinal (GI) safety, the audience of key worldwide rheumatologists and gastroenterologists felt that these drugs had excellent data with all three selective COX-2 inhibitors showing fewer gastrointestinal adverse events, with equal and reliable efficacy in management of arthritic pain. Physicians have been as worried about other side effects and anxious about using these drugs, particularly in elderly patients who have many medical problems and are taking multiple medications. Physicians need positive and clear information and guidance in terms of safety and efficacy

The symposium questioned the audience on key issues relating to treatment advances and any issues that may arise in the future. It was a truly interactive meeting, with all clinicians having the chance to raise the debate and question the panel. Early in the debate the issue was raised surrounding the controversial recommendation in the US from the FDA (Food & Drug Administration) Arthritis Advisory Panel.

The previous four months have seen noteworthy developments beginning in February when the FDA Arthritis Advisory Panel declined the marketers of the coxibs a request for the removal of the GI warning on the coxibs that appears on all NSAIDs. In a turnaround, the panel recommended some minor changes to the rofecoxib label, on the condition that there is a new warning indicating the higher risk of heart attacks present with this drug, as shown in their VIGOR trial.

Scientists have demonstrated that traditional Non Steroidal Anti-Inflammatory Drugs (NSAIDs) have caused gastrointestinal damage through inhibiting the COX-1 enzyme, which protects the stomach lining. Professor James Fries, Professor of Medicine, Stanford University School of Medicine, a panellist at the symposium commented: “Recent developments in the States have resulted in much anticipation for this debate. We have seen some excellent GI safety data in COX-1 sparing drugs, which cannot be questioned. Now the FDA Advisory Committee has expressed concerns that at least one of these drugs may pose additional risks when compared to the traditional NSAIDs. On the other hand, there may be cardioprotective features of drugs which inhibit COX-1. These are important issues that could affect prescribing decisions in the future when choosing the most suitable COX-1 sparing agent for an individual patient.’’

Meloxicam, the first selective COX-2 inhibitor treatment, is available in more than100 countries and has been used by an estimated 45 million patients. Extensive data from the MELISSA and SELECT studies have shown in more than 18,000 patients, that when compared with traditional NSAIDs, an equal efficacy with improved gastrointestinal tolerability was found with meloxicam. New findings from a pooled analysis of 35 clinical trials with 27,039 patients showed that rates of cardiovascular adverse events were low and similar for Mobic and two other commonly prescribed NSAIDs. These trials included over 15,000 patients who received meloxicam at daily doses ranging from 7.5 mg up to twice the maximum therapeutic dose. These safety findings are especially important in light of the medical community's concern about gastrointestinal and cardiovascular side effects of NSAIDs.

Dr. Henning Zeidler, Division of Rheumatology, Medical School Hanover, Germany, commenting on the safety of these products during the debate stressed: “The importance of observational studies provides evidence from the "real world" about patient care and enhances the evidence from double-blind randomised clinical trials and large-scale outcome studies. For meloxicam, extensive "real world" trials, data and experience exist. Controlled and randomized observational studies have revealed results consistent with the outcome of controlled clinical trials.”

In the United Kingdom, the National Institute for Clinical Excellence (NICE) included meloxicam, celecoxib and rofecoxib in a review of the selective COX-2 inhibitors This review will evaluate efficacy, safety and increased gastrointestinal tolerability in comparison to traditional NSAIDs. NICE aim to provide health professionals with clear guidelines on which medications should be used and in which circumstances in order to recommend the cost effective use of National Heath Service (NHS) resources. NICE decisions are also followed with interest by many European prescribing bodies. The final assessment from the institute is anticipated within the next weeks and should provide clinicians with a guideline on the appropriate use of these agents.

The audience at the debate were asked to vote on a number of questions relating to the safety and efficacy of the selective COX-2 drugs to establish majority votes. The conclusion from attending clinicians indicated that the overall safety of the available COX-2 inhibitors and not just the gastro-intestinal safety should be considered when prescribing these agents.

Speaking from the panel, Professor Dennis McCarthy, Chief of Gastroenterology at the University of New Mexico School of Medicine, stated: “"The US FDA has questioned the value (if any) of increased GI safety, in the face of no improvement in patient safety from the total of all side-effects. Thus, many critical questions remain surrounding the use of all these drugs, but the proven safety of meloxicam, good anti-inflammatory efficacy, freedom from other risks, e.g. fluid retention, hypertension, heart failure or myocardial infarction, and low cost, may yet lead to it emerging as the best all round NSAID in clinical use".

Professor Sir John Vane, who was awarded the Nobel Prize in Medicine in 1982 for his discovery of the mechanism of action of the NSAIDs, concluded: “This mode of inhibition is a breakthrough in arthritis treatment and this debate has helped clinicians put all the data into perspective, which is necessary. Now that we know that the efficacy and improved GI safety for all three drugs, meloxicam, celecoxib and rofecoxib are so similar, the physician will have to decide which one to use based on other factors such as non GI toxicity or price.”

The debate was run in conjunction with a web debate on www.mcox.tv, where clinicians are invited to log-on and submit their questions or to just hear more on the thoughts of clinicians from around the world on this controversial topic.



Boehringer Ingelheim

The Boehringer Ingelheim group of companies, headquartered in Ingelheim, Germany, is one of the 20 leading pharmaceutical corporations in the world. In 2000, it posted revenues of more than EUR 6 billion.

Boehringer Ingelheim, which has some 140 affiliated companies worldwide, focuses on human pharmaceuticals and animal health. The human pharmaceuticals business, which accounts for 95% of sales, is comprised of prescription medicines, consumer health care products and chemicals and biopharmaceuticals for industrial customers. Research and development, production, and distribution facilities are located around the globe. In 2000, Boehringer Ingelheim spent almost EUR 1.0 billion on R&D, equivalent to 16% of net sales.

For more information on Boehringer Ingelheim, please see the international Internet website www.boehringer-ingelheim.com

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