Cost-Effectiveness Analysis of n-3 Polyunsaturated Fatty Acids (PUFA) after Myocardial Infarction: Results from Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto (GISSI)-Prevenzione Trial

Objective: To estimate the cost effectiveness of treatment with n-3 polyunsaturated fatty acids (PUFA) for secondary prevention after myocardial infarction (MI). Design and setting: The cost-effectiveness analysis of n-3 PUFA treatment after MI was based on morbidity and mortality data and the use of resources obtained prospectively during the 3.5 year follow-up period of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto (GISSI)-Prevenzione study. The cost-effectiveness analysis took into account the incremental number of life-years gained and the incremental costs for hospital admissions, diagnostic tests and drugs, applying a 5% discount rate. The value for money of n-3 PUFA treatment was assessed using the cost-effectiveness ratio and the number needed to treat (NNT) approach. Perspective: Third-party payer. Main outcome measures and results: The incremental cost-effectiveness ratio for n-3 PUFA in the basecase scenario was 24 603 euro (EUR, 1999 values) per life-year gained (95% confidence interval: 22 646 to 26 930). Sensitivity analysis included the analysis of extremes, producing estimates varying from EUR15 721 to EUR52 524 per life-year gained. 172 patients would need to be treated per year with n-3 PUFA, at an annual cost of EUR68 000, in order to save 1 patient. This is comparable with the NNT value, and associated annual cost for simvastatin, but less costly than that for pravastatin. Conclusions: The cost effectiveness of long term treatment with n-3 PUFA is comparable with other drugs recently introduced in the routine care of secondary prevention after MI. Since the clinical benefit provided by n-3 PUFA is additive, this therapy should be added to the established routine practice, with additive costs.Anti ischaemics, Cost effectiveness, Myocardial infarction, Omega 3 fatty acid, Pharmacoeconomics, Unsaturated fatty acids

Diet and gallstones in Italy: The cross-sectional MICOL results

Fifteen thousand nine hundred ten men and 13,674 women (age, 30-69 years) were enrolled in an epidemiological survey of the general population, between December 1984 and April 1987. Each participant was submitted to ultrasonography (US) of the gallbladder and completed a food-frequency questionnaire, covering 38 food items. A common portion size was identified and subjects were asked how often each item was consumed. Nutrient intake was computed by multiplying the intake frequency and nutrient content per portion for each item, and then by summing the product over all foods. Each nutrient intake was adjusted for energy intake. Alcohol intake was calculated by summing the consumption of wine, beer, and liquor. Having excluded subjects aware of having gallstones (GS) or previously submitted to cholecystectomy (to avoid prothopatic bias), 787 males and 1,014 females with GS and 14,272 males and 10,836 females without GS were available for analysis, Relative risks (RR) of GS were computed by quintiles of nutrient intake. The overnight fasting period was calculated as the difference between the specified time of dinner and the time of the next meal (breakfast or lunch). A significant negative association was found between RR of GS and total energy intake for males (chi(2) for trend = 8.37; P =.004), fiber intake for females (chi(2) = 5.45; P =.02), and daily alcohol consumption for males (chi(2) = 10.86; P = .001). A positive association was observed between RR of GS and carbohydrate (chi(2) = 5.95; P =.01 for males; chi(2) = 9.39; P =.002 for females) and protein intake only for males (chi(2) = 10.92; P = .01). Prevalence of GS was higher among subjects who had an overnight fasting period of over 12 hours than subjects with that of less than 12 hours. (RR: 1.35; 95% CI: 1.01-1.80 for males; RR: 1.28; 95% CI: 1.03-1.60 for females). These data do not confirm that high energy intake is associated with an increased risk of GS, Factors protecting against GS comprise: low carbohydrate (males and females) and protein (males) intakes, high fiber (females) and moderate alcohol intake (males) consumption, and a shorter overnight fasting period for both sexes

Regular Wine Consumption in Chronic Heart Failure: Impact on Outcomes, Quality of Life, and Circulating Biomarkers

BACKGROUND: Moderate, regular alcohol consumption is generally associated with a lower risk of cardiovascular events but data in patients with chronic heart failure are scarce. We evaluated the relations between wine consumption, health status, circulating biomarkers, and clinical outcomes in a large Italian population of patients with chronic heart failure enrolled in a multicenter clinical trial. METHODS AND RESULTS: A brief questionnaire on dietary habits was administered at baseline to 6973 patients enrolled in the Gruppo Italiano per lo Studio della Sopravvivenza nell'Insufficienza Cardiaca-Heart Failure (GISSI-HF) trial. The relations between wine consumption, fatal and nonfatal clinical end points, quality of life, symptoms of depression, and circulating biomarkers of cardiac function and inflammation (in subsets of patients) were evaluated with simple and multivariable-adjusted statistical models. Almost 56% of the patients reported drinking at least 1 glass of wine per day. After adjustment, clinical outcomes were not significantly different in the predefined 4 groups of wine consumption. However, patients with more frequent wine consumption had a significantly better perception of health status (Kansas City Cardiomyopathy Questionnaire score, adjusted P<0.0001), less frequent symptoms of depression (Geriatric Depression Scale, adjusted P=0.01), and lower plasma levels of biomarkers of vascular inflammation (osteoprotegerin and C-terminal proendothelin-1, adjusted P<0.0001, and pentraxin-3, P=0.01) after adjusting for possible confounders. CONCLUSIONS: We show for the first time in a large cohort of patients with chronic heart failure that moderate wine consumption is associated with a better perceived and objective health status, lower prevalence of depression, and less vascular inflammation, but does not translate into more favorable clinical 4-year outcomes