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Irbesartan does not seem to reduce death, hospitalization in patients with preserved LVEF HF, study finds

Thursday, November 13 2008 | Comments
Evidence Grade 7 What's This?
By Patrice La Vigne

Although angiotensin II receptor blockers are commonly used to treat heart failure (HF) in patients with preserved left ventricular ejection fraction (LVEF), there are no clear data to support this approach. Dr. Peter Carson from Georgetown University and Washington D.C. Veterans Affairs Medical Center confirmed that the I-PRESERVE trial evaluating irbesartan did not show a significant benefit of the drug in this setting.

The international, double-blind trial included 4,128 patients aged 60 years or older (mean age, 72 years) who had HF symptoms, but whose LVEF was >=45% (preserved LVEF HF). A majority of patients had a New York Heart Association (NYHA) functional classification III. Patients were randomized to receive either placebo or irbesartan at an initial dose of 75 mg up-titrated during the study to a mean dose of 275 mg (n=2,067). Dr. Carson noted that most patients were well-treated and taking a diuretic and a beta blocker.

Follow-up continued until the occurrence of 1,440 primary endpoint events (composite of all-cause mortality and cardiovascular-related hospitalization for myocardial infarction [MI], HF, unstable angina, stroke, and arrhythmia).

The results revealed that during a mean follow-up of 49.5 months, 742 irbesartan-treated patients and 763 placebo-treated patients died or were hospitalized for cardiovascular reasons (HR, 0.95; 95% CI, 0.86-1.05; P=.35).

According to Dr. Carson, there was also no significant benefit observed with irbesartan in an analysis of secondary endpoints, which included all-cause mortality;  HF-related death or hospitalization; quality of life as measured by the Minnesota Living with Heart Failure Questionnaire; cardiovascular death, MI or stroke; and cardiovascular death.

Dr. Carson noted that irbesartan was safe and well tolerated nonetheless.

"In order for the field to move forward, a better understanding is needed of the mechanisms underlying this syndrome," he concluded.

Bristol-Myers Squibb Co. and Sanofi-Aventis Group funded the I-PRESERVE study. (Abstract Oral Session 3320.)

This information concerns a use that has not been approved by the Food and Drug Administration.

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