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Risk of Heart Attack and Cardiovascular Death Significantly Reduced by Atacand Therapy in Patients With Heart Failure

MÖLNDAL, SWEDEN -- October 11, 2005 -- Data published in the Journal of the American Medical Association today show that Atacand (candesartan cilexetil) is the first angiotensin receptor blocker (ARB) to significantly reduce cardiovascular death and nonfatal myocardial infarction (MI) in heart failure patients compared to placebo.

A new analysis of the CHARM (Candesartan in Heart Failure - Assessment of Reduction in Mortality and Morbidity) study programme at a median follow up time of 37.7 months shows the composite endpoint of cardiovascular death or nonfatal MI was significantly reduced in patients receiving candesartan compared to the placebo group, 20.4% versus 22.9% respectively (Hazard ratio [HR] 0.87, 95 % confidence interval [CI], 0.79-0.96; p=0.004). Nonfatal MI alone was also significantly reduced in the candesartan group, 3.1% versus 3.9% in the placebo group (HR 0.77, 95% CI, 0.60-0.98; p=0.03).

Lead author Dr Catherine Demers of McMaster University, Ontario, Canada commented on these new data: "Translated into patient benefit, these findings mean that one cardiovascular death or heart attack is prevented for every forty patients treated with candesartan for just over 3 years. The results support the use of candesartan in a broad spectrum of heart failure patients including those receiving standard optimal therapy."

The reduction of cardiovascular death or nonfatal MI in the actively treated group was consistent across relevant subgroups and the component trials in the CHARM study programme including patients treated with other therapies proven to be effective in reducing the risk of MI or reinfarction.

In November 2004, Atacand, already a well-established antihypertensive therapy, was granted EU* Marketing Authorisation for the treatment of patients with heart failure and left ventricular systolic dysfunction. In February 2005 the US Food and Drug Administration (FDA) approved Atacand for the treatment of heart failure (New York Heart Association Class II-IV and ejection fraction less than or equal to 40%). On 19 May 2005 the FDA also approved Atacand for use on top of ACE-inhibitors in the treatment of heart failure. Atacand is now approved for the treatment of heart failure in 49 countries.

These approvals of a CHF indication for Atacand are based on the positive results of the CHARM study programme. The results from CHARM identified Atacand as the first ARB to reduce both death and heart failure hospital admissions in chronic heart failure patients with left ventricular systolic dysfunction, irrespective of background therapy.

*The Mutual Recognition Procedure on this occasion covered all EU countries apart from France. The reference member state during this procedure was the UK. (* EU countries excluding France and prior to 2004 expansion. Belgium, Denmark, Germany, Greece, Spain, Ireland, Italy, Luxembourg, Netherlands, Austria, Portugal, Finland, Sweden, United Kingdom).


SOURCE: AstraZeneca

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