Trial results will help in treatment of arthritis

Rates of heart attack, stroke or death in patients with arthritis on the COX-2 inhibitor etoricoxib are similar to those in patients on the NSAID* diclofenac, according to an Online/Article published today (Monday November 13, 2006) by The Lancet. However, the drugs, which are both types of painkiller, were found to have different rates of other side-effects. This information will help doctors choose the best treatment for their patients, state the authors.

NSAIDs are often taken long term by arthritis patients. However, they can cause gastrointestinal (GI) bleeding and some studies have suggested that traditional NSAIDs, like diclofenac, can also increase cardiovascular** risk. COX-2 inhibitors reduce GI bleeding but they may increase the risk of cardiovascular events. The safety data for these drugs therefore raise concerns for patients with arthritis requiring long term treatment.

In the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) trial, Christopher Cannon (Brigham and Women's Hospital, Boston, MA, USA) and colleagues present the primary results of a randomised comparison of etoricoxib and diclofenac, involving patients with osteoarthritis or rheumatoid arthritis from 46 countries. In the study, 34 701 participants were randomly assigned to etoricoxib (60mg or 90 mg daily) or diclofenac (150mg daily) for an average of 18 months. The researchers found that the rate of adverse thrombotic cardiovascular events was similar for both treatment groups. They also found that the overall rate of upper GI events (ulcers, bleeding) was lower in patients taking etoricoxib, but the rate of life-threatening upper GI events were the same for both medications. Congestive heart failure was rare, but more common in the 90 mg etoricoxib group and more patients discontinued this drug dose due to swelling of the ankles. Both doses of etoricoxib had higher rates of discontinuation due to high blood pressure. Patients on diclofenac had higher rates of discontinuation due to adverse GI and liver events. Both drugs were similar in their effectiveness.

Dr Cannon concludes: "In clinical practice, the choice of anti-inflammatory agent needs to take into consideration the risk for thrombotic cardiovascular and gastrointestinal events, as well as congestive heart failure and other renovascular effects (eg, blood pressure, fluid retention), gastrointestinal tolerability (eg, dyspepsia), and efficacy…The data from this large randomised clinical trial should help clinicians and patients, and will hopefully encourage guideline committees to develop recommendations for optimum treatment of patients with arthritis."

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See also accompanying Comment.

Contact: Dr Cannon via Lori Shanks T) 617 534 1604 lshanks@partners.org

Notes to editors
*NSAID – non-steroidal anti-inflammatory drug
**Cardiovascular disease – class of diseases that involve the heart and/or blood vessels

The MEDAL results are being presented at the late-breaking clinical trial session at the American Heart association's (AHA) Scientific Sessions 2006 at 8am CST Monday November 13, 2006.


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