To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Omega-3 Polyunsaturated Fatty Acid Reduces All-Cause Mortality in CHF Patients: Presented at ESC URL: http://www.pslgroup.com/dg/22A38A.htm Doctor's Guide August 31, 2008
By Chris Berrie MUNICH, Germany -- August 31, 2008 -- Long-term administration of omega-3 polyunsaturated fatty acid (n-3 PUFA) reduces all-cause mortality and cardiovascular-related hospital admission in patients with symptomatic chronic heart failure (CHF), according to a multicentre, randomised, placebo-controlled trial presented here at the European Society of Cardiology 2008 Congress (ESC 2008). N-3 PUFA has shown favourable effects across a number of inflammatory and cardiovascular systems. More specifically, study co-chairman, Luigi Tavazzi, MD, Cardiovascular Division, University Hospital, Pavia, Italy, speaking on behalf of the GISSI-HF study investigators on August 31, discussed their previous study in postmyocardial infarction patients, "We saw no effects on nonfatal events but a 20% decrease in overall mortality, a 30% increase in cardiovascular death, and a 44% decrease in sudden death." However, there are no data of possible benefits for patients with CHF. The full GISSI-HF nested design study included adults aged 18 years or older with chronic symptomatic HF of any aetiology and at any level of left ventricular ejection fraction (LVEF). The exclusion criteria included contraindications or known hypersensitivity for n-3 PUFA, severe comorbidities, and acute coronary syndrome or cardiac procedure within the preceding month. For the initial part of the study with n-3 PUFA, the patients were randomised to either placebo (n = 3,481; mean age, 67 years; male, 79%) or to 1 g of oral n-3 PUFA daily (n = 3,494; mean age, 67 years; male, 78%). The control and n-3 PUFA groups were well matched according to HF characteristics and medical histories. Their disease aetiology was mainly ischaemic (50% vs 49%, respectively), dilatative (28% vs 30%), and hypertensive (16% vs 14%), with two-thirds in each group having a New York Heart Association (NYHA) functional capacity of class 2, and just under 10% with a LVEF >40%. Their concomitant medical treatments were well matched, with 90% of patients on angiotensin-converting enzyme (ACE) inhibitors and diuretics and two-thirds on beta-blockers. The primary endpoints were all-cause death and all-cause death or hospitalisation for cardiovascular reasons. At 3.9 years median follow-up, for time to all-cause death, the 1.8% absolute risk reduction (RR) for n-3 PUFA reached statistical significance (adjusted hazard ratio [aHR], 0.91; 95% confidence interval [CI], 0.83-0.99; P = .041). The second primary endpoint showed a significant 2.3% absolute RR (aHR, 0.92; 95% CI, 0.85-0.99; P = .009). Additionally, as Dr. Tavazzi said, "We had a number of predefined secondary outcomes, and the relative risk reduction was consistent from 0.90 to 0.94 over the control group." For all predefined subgroup analyses, none of the low but consistent trends in favour of n-3 PUFA reached significance. Permanent treatment discontinuations (29%) and adverse drug reactions (3%) remained low, with no significant differences seen across treatment groups. In conclusion, Dr. Tavazzi noted that the benefit of n-3 PUFA was moderate and smaller than expected. "But it was obtained on top of recommended therapies, it was consistent across all predefined subgroups, and it was supported by the per-protocol analysis, in which the relative risk reduction reached from 12% to 14%," he added. Funding for this study was provided by SPA, Pfizer, Sigma Tau, and AstraZeneca. [Study title: Effects of n-3 PUFA in Patients With Symptomatic Chronic Heart Failure: The GISSI-HF Results. Hot Line I. Abstract 234] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.