FDA approves Atacand (candesartan cilexetil) for the treatment of heart failure

Feb 23 2005

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved its angiotensin receptor blocker (ARB) Atacand (candesartan cilexetil) Tablets for the treatment of heart failure (NYHA class II-IV and ejection fraction less than or equal to 40%) to reduce the risk of death from cardiovascular causes and reduce hospitalizations for heart failure.

Atacand is the first ARB to receive an indication for reducing both cardiovascular mortality and hospitalizations for heart failure.

The 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 2,028 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% (p<0.001) relative risk reduction in cardiovascular death or heart failure hospitalization (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 2,548 subjects (CHARM-Added) with NYHA Class II-IV heart failure and ejection fraction less than or equal to 40%, in which subjects were mostly on submaximal doses of ACE inhibitors. Together, in these studies, patients on Atacand had a 15% 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).

The recommended initial dose of Atacand for the treatment of heart failure is 4 mg once daily. The target dose is 32 mg once daily, which is achieved by doubling the dose at approximately two-week intervals, as tolerated by the patient.