GISSI–HF trial - Summary & Results

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A large-scale, randomized, double-blind study on Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico–Heart Failure (GISSI–HF) designed to investigate the effects of omega-3 fatty acids and statin therapy on mortality and morbidity in patients with CHF (NYHA class 2–4 regardless of cause and LVEF)

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  • 1. GISSI–HF (Gruppo Italiano per lo Studiodella Sopravvivenza nellInfartoMiocardico–Heart Failure)
  • 2. GISSI–HF (Gruppo Italiano per lo Studio dellaSopravvivenza nellInfarto Miocardico–Heart Failure)• GISSI–HF project: A large-scale, randomized, double-blind study designed to investigate the effects of omega-3 fatty acids and statin therapy on mortality and morbidity in patients with CHF (NYHA class 2–4 regardless of cause and LVEF)• Treatments in the two separate substudies:GISSI–HF, PUFA study GISSI–HF statinn-3 PUFA 1 g daily or placebo Rosuvastatin 10 mg or placebo• Co–primary end points: Death and death or admission to the hospital for CV reasons CHF=chronic heart failure PUFA=polyunsaturated fatty acids
  • 3. GISSI–HF: ResultsL Tavazzi (Fondazione IRCCS Policlinico San Matteo, Pavia, Italy)European Society of Cardiology 2008 CongressGISSI–HF PUFA: Primary and secondary outcomesaEnd point Omega-3 fatty acids Placebo Adjusted hazard ratio (n=3494), % (n=3481), % (95% CI)Primary end pointsMortality 27.3 29.1 0.91 (0.833–0.998)All-cause mortality or hospitalization for 56.7 59.0 0.92 (0.849–0.999)CV causesSecondary end pointsDeath from CV causes 20.4 22.0 0.90 (0.81–0.99)Sudden cardiac death 8.8 9.3 0.93 (0.79–1.08)Patients admitted for CV causes 46.8 48.5 0.93 (0.87–0.99)Patients with fatal and nonfatal MI 3.1 3.7 0.82 (0.63–1.06)Patients with fatal and nonfatal stroke 3.5 3.0 1.16 (0.91–1.53) aAt follow-up of 3.9 years
  • 4. GISSI–HF: ResultsG Tognoni (Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy)European Society of Cardiology 2008 CongressGISSI–HF statin: Primary outcomesaEnd point Rosuvastatin 10 mg (n=2285), Placebo Adjusted hazard ratio % (n=2289), % (95% CI)Mortality 29.0 28.0 1.00 (0.898–1.122)All-cause mortality or hospitalization for 57.0 56.0 1.01 (0.908–1.112)CV causes• Long-term administration of omega-3 fatty acids reduced all-cause mortalityand admission to the hospital for CV causes, while there was no effect on theseend points with 10-mg rosuvastatin aAt follow-up of 3.9 years
  • 5. GISSI–HF: Commentary*"Although statin therapy lowers concentrations of LDL cholesterol, is well tolerated,and seems reasonably safe, it does not produce meaningful improvements insurvival in patients with chronic heart failure." - Dr Gregg Fonarow"What this study has done is extend what we knew from CORONA, a study wheremore patients had severe heart failure, to those with less severe heart failure." - Dr Philip Poole-Wilson *All comments from Omega-3 fatty acids, but not statin therapy, cuts mortality and hospitalizations in heart failure (http://www.theheart.org/article/898959.do)
  • 6. Become a member of http://www.theheart.org Become a fan on Facebook: http://www.facebook.com/theheartorg Follow us on Twitter: http://www.twitter.com/theheartorgtheheart.org is the leading online source of independent cardiology news.We are the top provider of news and opinions for over 100 000 physicians.