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n-3 PUFAs Reduce Mortality and Hospital Admissions in Patients With Symptomatic Heart Failure
Date:9/2/2008

1)

* Difference between groups statistically significant (adjusted analysis; adapted from reference 1)

The GISSI group initiated, designed and conducted the GISSI-HF trial following positive results of a post-hoc analysis of the GISSI-Prevenzione trial (see Notes to Editors) which demonstrated that a subgroup of post-myocardial infarction patients with left ventricular dysfunction had reduced all-cause mortality and hospitalisations with n-3 PUFAs (2).

The primary objectives of the GISSI-HF trial were to demonstrate whether n-3 PUFAs or rosuvastatin improved all-cause mortality or hospitalisations for cardiovascular reasons. Participants were first randomised to receive n-3 PUFAs vs placebo (ORT). A subset of study participants was further randomised to receive rosuvastatin vs placebo.

GISSI-HF-the second large-scale cardiovascular outcome trial of n-3 PUFAs-also confirmed and further supports the safety of n-3 PUFAs, whose cardiovascular benefit in post- myocardial infarction patients had been established by the GISSI-Prevenzione trial (3). Accordingly, current indications of n-3 PUFAs are secondary prevention in post-myocardial infarction patients and treatment of hypertriglyceridaemia. Ongoing studies of n-3 PUFAs in other cardiovascular indications may unveil additional benefits in patients with cardiovascular diseases.

Professor Clemens Von Schacky, Head of Preventive Cardiology, University of Munich, Germany, also reviewed the GISSI-HF trial outcomes and presented the implications of these results for clinical practice during a Solvay-sponsored symposium at ESC 2008. He commented. "Very recently, we have seen a number of large outcome trials in congestive heart failure using a variety of approaches. Unfortunately, these were either neutral or negative. In sharp contrast, GISSI-HF, a meticulously conducted trial, reported the safety and efficacy of n-3 PUFAs in this patient population. Thus, evidence has been provided for guid
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SOURCE Solvay Pharmaceuticals
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