on April 8, 2002
Circulation. 2002
Published online before print April 8, 2002, doi: 10.1161/01.CIR.0000014682.14181.F2
Published online before print April 8, 2002, doi: 10.1161/01.CIR.0000014682.14181.F2
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Submitted on December 12, 2001
From the Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, Santa Maria Imbaro, Chieti (R.M., F.B., E.B., R.D.M., R.M.M., G.T.); Ospedale Civile, Caserta (C.C.); Ospedale Civile, Lanciano (D.D.G., L.M., G.M., C.T.); Department of Cardiovascular Research, Istituto Mario Negri, Milano (M.G.F.); Ospedale Cervello, Palermo (E.G.); Ospedale Civile, Vasto (G.L.); Centro Studi ANMCO, Firenze (A.P.M.); Ospedale Civile, Napoli (N.M.); Ospedale S. Maria degli Angeli, Pordenone (G.L.N.); Ospedale San Filippo Neri, Roma (M.S.); Ospedale Civile, Presidio di Riabilitazione, Passirana di Rho, Milano (C.S.); and IRCCS Policlinico San Matteo, Pavia (L.T.); Ospedale San Gerardo Nuovo, Monza (F.V.), Italy. * To whom correspondence should be addressed. E-mail: marchioli{at}negrisud.it.
Background—Our purpose was to assess the time course of the benefit of n-3 polyunsaturated fatty acids (PUFAs) on mortality documented by the GISSI-Prevenzione trial in patients surviving a recent (<3 months) myocardial infarction. Methods and Results—In this study, 11 323 patients were randomly assigned to supplements of n-3 PUFAs, vitamin E (300 mg/d), both, or no treatment (control) on top of optimal pharmacological treatment and lifestyle advice. Intention-to-treat analysis adjusted for interaction between treatments was carried out. Early efficacy of n-3 PUFA treatment for total, cardiovascular, cardiac, coronary, and sudden death; nonfatal myocardial infarction; total coronary heart disease; and cerebrovascular events was assessed by right-censoring follow-up data 12 times from the first month after randomization up to 12 months. Survival curves for n-3 PUFA treatment diverged early after randomization, and total mortality was significantly lowered after 3 months of treatment (relative risk [RR] 0.59; 95% CI 0.36 to 0.97; P=0.037). The reduction in risk of sudden death was specifically relevant and statistically significant already at 4 months (RR 0.47; 95% CI 0.219 to 0.995; P=0.048). A similarly significant, although delayed, pattern after 6 to 8 months of treatment was observed for cardiovascular, cardiac, and coronary deaths. Conclusions—The early effect of low-dose (1 g/d) n-3 PUFAs on total mortality and sudden death supports the hypothesis of an antiarrhythmic effect of this drug. Such a result is consistent with the wealth of evidence coming from laboratory experiments on isolated myocytes, animal models, and epidemiological and clinical studies.
Revised on February 12, 2002
Accepted on February 12, 2002
Early Protection Against Sudden Death by n-3
Polyunsaturated Fatty Acids After Myocardial Infarction. Time-Course Analysis
of the Results of the Gruppo Italiano per lo Studio della Sopravvivenza
nell'Infarto Miocardico (GISSI)-Prevenzione
Roberto Marchioli MD*,
Key words: fatty acids • death, sudden • trials • coronary disease • antiarrhythmia agents
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