It is hoped the angiotensin receptor blocking (ARB) drug will help reduce cardiovascular death and reduce heart failure hospitalizations in this patient population. The re-labeling will allow it to be used alone or with conventional heart failure therapies.
The FDA decision was based primarily on results from trial data which examined the effect of Atacand in 2,548 heart failure patients who were already receiving conventional therapy. The study demonstrated that the addition of Atacand resulted in a 15% relative-risk reduction in cardiovascular death or heart failure hospitalization.
When assessing the impact of traditional therapies Howard Hutchinson, vice president of clinical research at AstraZeneca said: “ACE inhibitors and beta-blockers have improved the treatment of heart failure. Despite this, rates of cardiovascular death and heart failure hospitalization remain high.”
He went on to add: “With this approval, physicians will have an option to add Atacand to conventional therapies, including an ACE inhibitor, which can improve treatment outcomes for heart failure patients.”