Atacand approved to reduce both cardiovascular morbidity and hospitalizations for heart failure
LONDON, U.K., February 23, 2005 -- AstraZeneca announced that the FDA has approved its angiotensin receptor blocker (ARB) Atacand (candesartan cilexetil) for the treatment of heart failure (New York Heart Association Class II-IV and ejection fraction less than or equal to 40 percent) to reduce the risk of death from cardiovascular causes and reduce hospitalisations from heart failure.
Atacand is the first ARB in the U.S. to receive an indication for reducing both cardiovascular mortality and hospitalisations for heart failure. The U.S. approval was primarily based on results from Candesartan in Heart Failure Assessment of Reduction in Mortality and morbidity Alternative Trial (CHARM-Alternative), which examined the effect of Atacand (n= 1013) compared to placebo (n=1015) in 2028 heart failure patients who were intolerant to ACE inhibitors, but were receiving other standard heart failure therapy.
The trial demonstrated that, in these CHF patients, the use of Atacand resulted in a 23 percent (p<0.001) relative risk reduction in cardiovascular death or heart failure hospitalisation (406 events in the placebo arm compared to 334 events in the patients receiving Atacand), with both components contributing to this effect.
This finding was supported by a second study of 2548 subjects (CHARM-Added) with New York Heart Association (NYHA) Class II-IV heart failure and ejection fraction less than or equal to 40 percent, in which subjects were already on ACE inhibitors. Together, in these studies, patients on Atacand had a 15 percent lower risk of cardiovascular mortality (p=0.005). In these studies, symptoms of heart failure as assessed by NYHA functional class were also improved (p<0.001).
In November 2004, AstraZeneca announced that the European Mutual Recognition Variation Procedure (MRP) evaluating the use of Atacand for the treatment of patients with heart failure and impaired left ventricle systolic function had been completed.
Posted: February 2005