Abstract
BackgroundCombined treatment (CT) with statins and polyunsaturated fatty acids (n-3 PUFA) resulted in a reduction of death and major cardiovascular events when administered after a myocardial infarction (MI). However, recent data suggests that CT may be ineffective because patients are currently treated aggressively and the risk may not be further decreased. We aimed to study the prevalence and the results on major outcomes with CT among patients discharged with a MI in Italy.Methodology/Principal findingsRetrospective cohort study that used linked hospital discharge, prescription databases and vital statistics containing information on 14,704 patients who were discharged for MI between 1/2003 and 12/2003 in 117 hospitals in Italy. All analyses were time-dependent and adjusted for major confounders. Sensibility and paired matched analysis were conducted to further verify main results. A total of 11,532 (78.4%) filled a prescription for a statin. Of these, 4302 (37.3%) were on CT. There were 45,528 patients/years of follow-up. As compared with statins alone, CT was associated with an adjusted higher survival rate (HR = 0.59 [0.52–0.66], p<0.001), survival free of atrial fibrillation (HR = 0.78 [0.71–0.86], p<0.001) and survival free of new heart failure development (HR = 0.81 [0.74–0.88], p<0.001), but not with re-infarction (HR = 0.94 [0.86–1.02], p<0.127). Clinically this means that between 2 to 3 fewer events for each 100 patients/year were obtained in the group under CT.Conclusions/SignificanceAmong a representative sample of patients discharged with MI in Italy, we observed clinically significant synergism between the effects of statins and n-3 PUFA for most cardiovascular outcomes, including all cause mortality.
Highlights
The landmark GISSI Prevenzione trial demonstrated that an oral supplementation with 1 daily gram of n-3 PUFA was associated with a decreased mortality and improve outcomes in post-myocardial infarction (MI) patients, mostly by a reduction in cardiac arrhythmias [1,2]
Results of Paired Matched Analysis Overall, 3,962 patients prescribed with statins plus n-3 PUFA
The analyses revealed that between 2 to 3 fatal and nonfatal events could be avoided for each hundred patients prescribed annually with the combination therapy as compared with those prescribed with statins, and this advantage appears to be independent of concomitant use of other preventive drugs
Summary
The landmark GISSI Prevenzione trial demonstrated that an oral supplementation with 1 daily gram of n-3 PUFA was associated with a decreased mortality and improve outcomes in post-MI patients, mostly by a reduction in cardiac arrhythmias [1,2]. One of the most cited hypothetical reason inform that within the last 10 years, patients become more aggressively treated with statins, and that fish oil may have a ceiling effect on top of the compounds. In the factorially designed GISSI-HF study, neutral effects were found for rosuvastatin while n-PUFA proved efficacious in decreasing mortality, with further evidence of an antiarrhythmic component [11]. Recent data suggests that CT may be ineffective because patients are currently treated aggressively and the risk may not be further decreased.
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