FDAnews Drug Daily Bulletin

STUDY: COMBINED THERAPY IMPROVES HEART FAILURE TREATMENT

May 15, 2006
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Patients face a reduced risk of cardiovascular death and heart failure hospitalizations when an Angiotensin-converting Enzyme (ACE) inhibitor is combined with use of AstraZeneca's drug Atacand, a study published in the May issue of the American Heart Journal finds.

An AstraZeneca-sponsored study found that treatment was significantly more effective when Atacand (candesartan cilexetil) was combined with the ACE inhibitor than when the inhibitor was used alone. ATACAND is the only angiotensin II receptor blocker indicated to provide these clinical benefits for heart failure patients already receiving adequate doses of an ACE inhibitor, the company says.

Specifically, the Candesartan in Heart failure: Assessment of Reduction in Mortality and Morbidity (CHARM)-Added trial concluded that the drug reduced the relative risk for the primary end point of cardiovascular death or heart failure hospitalization significantly compared to placebo (hazard ratio (HR) 0.85, 95% confidence intervals (CI) 0.75-0.96, p=0.011). This outcome was consistent in patients taking a guideline-recommended ACE inhibitor dose and for those taking an FDA-designated maximum ACE inhibitor dose, (HR) 0.79, 95% CI 0.67-0.95; HR 0.75, 95% CI 0.57-0.98, respectively).