The FDA ( Food and Drug Administration ) has approved its angiotensin receptor blocker ( sartan ) Candesartan Cilexetil ( Atacand ) for the treatment of heart failure ( NYHA II-IV and ejection fraction less than or equal to 40% ) to reduce the risk of death from cardiovascular causes and reduce hospitalisations from heart failure.
Candesartan Cilexetil is the first angiotensin receptor blocker in the US to receive an indication for reducing both cardiovascular mortality and hospitalisations for heart failure.
The US 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 Candesartan Cilexetil ( 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 Candesartan Cilexetil resulted in a 23% ( p less than 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 Candesartan ), 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%, in which subjects were already on ACE inhibitors.
Together, in these studies, patients on Candesartan 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 less than 0.001). ( Xagena )
Source: AstraZeneca, 2005