Monday, November 5, 2007

AHA - 2007: Researchers examine benefits of statins for heart failure patients

Researchers examine benefits of statins for heart failure patients

Late-Breaking Clinical Trials News Release 9

ORLANDO, Nov. 5 – Results of a clinical trial to determine the efficacy and safety of adding rosuvastatin 10 mg to optimal therapy in patients with ischemic heart disease and systolic heart failure were presented as late-breaking research at the American Heart Association’s Scientific Sessions 2007.

“Because patients with symptomatic heart failure were excluded from past placebo-controlled trials with statins, the benefits and risks of statins in the treatment of heart failure remain uncertain,” said Åke Hjalmarson, an investigator in the Sweden-based Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA). CORONA was designed to clarify the role of statin therapy in treating patients with systolic heart failure.

CORONA is a randomized, double-blind, placebo-controlled study of 5,011 men and women with chronic symptomatic systolic heart failure (caused by coronary artery disease). Average patient age was 73 years, 24 percent were women, 37 percent were in New York Heart Association (NYHA) class II heart failure and 62 percent in class III. The average ejection fraction (EF) was 31 percent. Ejection fraction is a measure of how much blood the heart’s left ventricle pumps out with each contraction. The normal EF is 50 percent or greater.

The average total cholesterol among patients was 200 mg/dL. Participants were not already taking cholesterol-lowering drugs. Patient medical histories included 60 percent with a history of heart attack, 63 percent with hypertension and 30 percent with diabetes.

“These patients were well-treated for their heart failure,” Hjalmarson said, with 87 percent on loop or thiazide diuretics, 39 percent on aldosterone antagonists, 91 percent taking an ACE inhibitor or AT-I blocker, 75 percent taking a beta-blocker, and 33 percent taking digitalis. In addition, 51 percent were taking aspirin and 36 percent taking anticoagulants.

Patients were randomized to receive either rosuvastatin (10 mg) or placebo along with all other medications. Average follow-up time was 2.5 years.

The primary objective of CORONA was to determine whether rosuvastatin reduces the number of patients suffering from cardiovascular death, non-fatal heart attack or non-fatal stroke.

Support for this study was provided by AstraZeneca.

Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The American Heart Association makes no representation or warranty as to their accuracy or reliability.

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