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No benefit from irbesartan in patients with normal ejection fraction heart failure
The I-PRESERVE study (Irbesartan in Heart Failure with Preserved Ejection Fraction) assessed the efficacy of the angiotensin II receptor blocker, irbesartan, on mortality and cardiovascular morbidity in patients with heart failure and a preserved left ventricular ejection fraction. This was a multicentre international trial which enrolled 4128 patients with a minimum age of 60 years and NYHA class II–1V heart failure with a left ventricular ejection fraction of at least 45%. Patients were randomly assigned to receive 300 mg irbesartan or placebo each day. The primary composite outcome was death from any cause or hospitalisation for any cardiovascular cause. Secondary outcomes included death from heart failure or hospitalisation for heart failure, death from any cause and from cardiovascular causes, and quality of life.
Patients were followed up for a mean of 49.5 months. The primary end point occurred in 742 patients in the irbesartan arm and 763 in the placebo arm. Primary event rates in the irbesartan and placebo groups were 100.4 and 105.4/1000 patient-years respectively (HR = 0.95, 95% CI 0.86 to 1.05, p = 0.35). Overall rates of death were 52.6 and 52.3/1000 patient-years, respectively (HR = 1.00, 95% CI 0.88 to 1.14, p = 0.98). Rates of hospitalisation for cardiovascular causes contributing to the primary outcome were 70.6 and 74.3/1000 patient-years, respectively (HR = 0.95, 95% CI 0.85 to 1.08, p = 0.44).
Treatment with irbesartan did not reduce the risk of either the primary or any of the secondary end points. This contrasts with the clear benefit of blockade of the renin–angiotensin–aldosterone system in patients with heart failure and low ejection fraction, but these findings are consistent with those from two other studies involving patients with heart failure and preserved ejection fraction: CHARM (Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity) and PEP-CHF (Perindopril in Elderly People with Chronic Heart Failure). The reasons for this …