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I-PRESERVE: No reduction in mortality in patients with HF

Issue: December 2008

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The angiotensin receptor blocker irbesartan did not reduce the risk for mortality or cardiovascular morbidity in patients with heart failure who had preserved left ventricular ejection fraction, according to the results of the I-PRESERVE trial.

Researchers for the Irbesartan in Heart Failure With Preserved Systolic Function (I-PRESERVE) study enrolled 4,128 patients with HF who had preserved LV ejection fraction (<0.45) into the randomized, double-blind study. Patients were then randomized after two weeks of single-blinded enrollment into either an irbesartan (Avapro, Bristol-Myers Squibb, Sanofi Agentis) group (n=2,067) or a placebo group (n=2,061). The primary endpoint of the study was death or hospitalization for HF, MI, stroke or arrhythmia. Patients were followed until 1,140 occurrences of the primary endpoint occurred.

According to study results presented by Peter Carson, MD, associate professor of medicine at Georgetown University, there was no difference in the effect on the primary endpoint between irbesartan and placebo (HR=0.95; 95% CI, 0.86-1.05) at 60 months. The researchers also reported that there was no difference between irbesartan (n=306) and placebo (n=296) for the secondary endpoint of CV mortality (HR=1.02; 95% CI, 0.87-1.19), nor was there a difference between irbesartan (n=436) and placebo (n=445) for the secondary endpoint of HF death or hospitalization (HR=1.01; 95% CI, 0.88-1.16).

For more information:

• Carson P. #3320. LBCTIII

It is important to have this study because ACE-inhibitors and angiotensin-receptor blockers are very commonly used to treat this condition even though there are no compelling randomized clinical trials to support that. Although we know that hypertensive heart disease, hypertrophy and necrosis undoubtedly play a very important role in this condition, these findings ask if there must be additional mechanisms that can influence the progression of HF in this syndrome. Unfortunately, it is becoming increasingly apparent that the pathophysiology is not as simple as we first thought, and also that the pathophysiology of aging contributes to the progression of HF in these patients. We have a lot of work to do not only identifying the pathophysiology of this syndrome, but also developing and testing novel therapies that may have a different result.

– Margaret M. Redfield, MD
Professor of Medicine, Mayo Clinic, Rochester, Minn.