title: n-3 fatty acids in patients with multiple cardiovascular risk factors.
abstract: Trials have shown a beneficial effect of n-3 polyunsaturated fatty acids in patients with a previous myocardial infarction or heart failure. We evaluated the potential benefit of such therapy in patients with multiple cardiovascular risk factors or atherosclerotic vascular disease who had not had a myocardial infarction.
  
  
  
  In this double-blind, placebo-controlled clinical trial, we enrolled a cohort of patients who were followed by a network of 860 general practitioners in Italy. Eligible patients were men and women with multiple cardiovascular risk factors or atherosclerotic vascular disease but not myocardial infarction. Patients were randomly assigned to n-3 fatty acids (1 g daily) or placebo (olive oil). The initially specified primary end point was the cumulative rate of death, nonfatal myocardial infarction, and nonfatal stroke. At 1 year, after the event rate was found to be lower than anticipated, the primary end point was revised as time to death from cardiovascular causes or admission to the hospital for cardiovascular causes.
  
  
  
  Of the 12,513 patients enrolled, 6244 were randomly assigned to n-3 fatty acids and 6269 to placebo. With a median of 5 years of follow-up, the primary end point occurred in 1478 of 12,505 patients included in the analysis (11.8%), of whom 733 of 6239 (11.7%) had received n-3 fatty acids and 745 of 6266 (11.9%) had received placebo (adjusted hazard ratio with n-3 fatty acids, 0.97; 95% confidence interval, 0.88 to 1.08; P=0.58). The same null results were observed for all the secondary end points.
  
  
  
  In a large general-practice cohort of patients with multiple cardiovascular risk factors, daily treatment with n-3 fatty acids did not reduce cardiovascular mortality and morbidity. (Funded by Società Prodotti Antibiotici and others; ClinicalTrials.gov number, NCT00317707.).
authors: Istituto di Ricovero e Cura a Carattere Scientifico–Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy
authors: Maria Carla
authors: MC
authors: Roncaglioni
authors: Centro Studi e Ricerche in Medicina Generale, Monza, Italy
authors: Massimo
authors: M
authors: Tombesi
authors: Istituto di Ricovero e Cura a Carattere Scientifico–Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy
authors: Fausto
authors: F
authors: Avanzini
authors: Istituto di Ricovero e Cura a Carattere Scientifico–Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy
authors: Simona
authors: S
authors: Barlera
authors: Centro Studi e Ricerche in Medicina Generale, Monza, Italy
authors: Vittorio
authors: V
authors: Caimi
authors: Centro Studi e Ricerche in Medicina Generale, Monza, Italy
authors: Paolo
authors: P
authors: Longoni
authors: Istituto di Ricovero e Cura a Carattere Scientifico–Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy
authors: Irene
authors: I
authors: Marzona
authors: Istituto di Ricovero e Cura a Carattere Scientifico–Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy
authors: Valentina
authors: V
authors: Milani
authors: Consorzio Mario Negri Sud, Santa Maria Imbaro, Chieti, Italy
authors: Maria Giuseppina
authors: MG
authors: Silletta
authors: Consorzio Mario Negri Sud, Santa Maria Imbaro, Chieti, Italy
authors: Gianni
authors: G
authors: Tognoni
authors: Consorzio Mario Negri Sud, Santa Maria Imbaro, Chieti, Italy
authors: Roberto
authors: R
authors: Marchioli
mesh_terms: D000368:Aged; D002318:Cardiovascular Diseases / Q000401:mortality / Q000517:prevention & control*; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D058006:General Practice; D006760:Hospitalization; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011322:Primary Prevention; D016016:Proportional Hazards Models; D012307:Risk Factors; D017211:Treatment Failure
chemical_list: D015525:Fatty Acids, Omega-3