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Background The long-term effects of sibutramine treatment on the rates of cardiovascular events and cardiovascular death among subjects at high cardiovascular risk have not been established. Methods We enrolled in our study 10,744 overweight or obese subjects, 55 years of age or older, with preexisting cardiovascular disease, type 2 diabetes mellitus, or both to assess the cardiovascular consequences of weight management with and without sibutramine in subjects at high risk for cardiovascular events. All the subjects received sibutramine in addition to participating in a weight-management program during a 6-week, single-blind, lead-in period, after which 9804 subjects underwent random assignment in a double-blind fashion to sibutramine (4906 subjects) or placebo (4898 subjects). The primary end point was the time from randomization to the first occurrence of a primary outcome event (nonfatal myocardial infarction, nonfatal stroke, resuscitation after cardiac arrest, or cardiovascular death). Results The mean duration of treatment was 3.4 years. The mean weight loss during the lead-in period was 2.6 kg; after randomization, the subjects in the sibutramine group achieved and maintained further weight reduction (mean, 1.7 kg). The mean blood pressure decreased in both groups, with greater reductions in the placebo group than in the sibutramine group (mean difference, 1.2/1.4 mm Hg). The risk of a primary outcome event was 11.4% in the sibutramine group as compared with 10.0% in the placebo group (hazard ratio, 1.16; 95% confidence interval [CI], 1.03 to 1.31; P=0.02). The rates of nonfatal myocardial infarction and nonfatal stroke were 4.1% and 2.6% in the sibutramine group and 3.2% and 1.9% in the placebo group, respectively (hazard ratio for nonfatal myocardial infarction, 1.28; 95% CI, 1.04 to 1.57; P=0.02; hazard ratio for nonfatal stroke, 1.36; 95% CI, 1.04 to 1.77; P=0.03). The rates of cardiovascular death and death from any cause were not increased. Conclusions Subjects with preexisting cardiovascular conditions who were receiving long-term sibutramine treatment had an increased risk of nonfatal myocardial infarction and nonfatal stroke but not of cardiovascular death or death from any cause. (Funded by Abbott; ClinicalTrials.gov number, NCT00234832.)

This study is a consensus document of two Spanish scientific associations, FESNAD (Spanish Federation of Nutrition, Food and Dietetic Associations) and SEEDO (Spanish Association for the Study of Obesity), about the role of the diet in the treatment of overweight and obesity in adults. It is the result of a careful and systematic review of the data published in the medical literature from January 1st 1996 to January 31st 2011 concerning the role of the diet on obesity treatment. The achieved conclusions have been classified into various evidence levels. Subsequently in agreement with these evidence levels, different degree recommendations are established being potentially useful to design food guides as part of strategies addressed to the treatment overweight and obesity. Se presenta un consenso de la Federación Española de Sociedades de Nutrición, Alimentación y Dietética (FESNAD) y la Sociedad Española para el Estudio de la Obesidad (SEEDO)) sobre la dieta en el tratamiento de la obesidad, tras efectuar una revisión sistemática de los datos de la literatura médica desde el 1 de enero de 1996 al 31 de enero de 2011. Las conclusiones obtenidas se han catalogado según niveles de evidencia. Se establecen unas recomendaciones clasificadas según grados que pueden servir de guía y orientación en el diseño de pautas alimentarias dirigidas al tratamiento de la obesidad o el sobrepeso.

This study is a consensus document of two Spanish scientific associations, FESNAD (Spanish Federation of Nutrition, Food and Dietetetic Associations) and SEEDO (Spanish Association for the Study of Obesity), about the role of the diet in the prevention and of overweight and obesity in adults. It is the result of a careful and systematic review of the data published in the medical literature from January 1st 1996 to January 31st 2011 concerning the role of the diet on obesity prevention. The conclusions obtained have been classified according several evidence levels. Subsequently, in agreement with these evidence levels, different degree recommendations are established. These recommendations could be potentially useful to design food guides as part of strategies to prevent overweight and obesity. Se presenta un consenso de la Federación Española de Sociedades de Nutrición, Alimentación y Dietética (FESNAD) y la Sociedad Española para el Estudio de la Obesidad (SEEDO) sobre la dieta en la prevención del sobrepeso y la obesidad, tras efectuar una revisión sistemática de los datos de la literatura médica desde el 1 de enero de 1996 al 31 de enero de 2011. Las conclusiones obtenidas se han catalogado según niveles de evidencia. Se establecen unas recomendaciones clasificadas según grados que pueden servir de guía y orientación en el diseño de pautas alimentarias dirigidas a la prevención de la obesidad o el sobrepeso.

The present study is a consensus document of two Spanish scientific associations, FESNAD (Spanish Federation of Societies of Nutrition, Food and Dietetics Associations) and SEEDO (Spanish Association for the Study of Obesity), about the role of the diet in the prevention and treatment of overweight and obesity in adults. In this part of the document the methodology and the classification of levels of evidence are described. In order to reach the strongest evidence possible, a systematic review of 543 medical studies dealing with these issues published in the last 15 years (from January 1st 1996 to January 31st 2011) has been conducted. In the executive summary, along with the obtained evidences, a set of degree-classified recommendations are established. These recommendations could constitute a useful tool to design food guides addressed to the nutritional counseling for obesity and overweight treatment. En el presente trabajo se describe la metodología y los grados de evidencia utilizados en la elaboración del documento de consenso de la Federación Española de Sociedades de Nutrición, Alimentación y Dietética (FESNAD) y la Sociedad Española para el Estudio de la Obesidad (SEEDO) sobre el papel de la dieta en la prevención y el tratamiento de la obesidad y el sobrepeso. Para obtener la mayor evidencia posible se ha efectuado una revisión sistemática de los datos de la literatura médica desde el 1 de enero de 1996 al 31 de enero de 2011 (15 años). En el resumen ejecutivo, junto a las evidencias alcanzadas, se establecen unas recomendaciones clasificadas según grados que pueden servir de guía y orientación en el diseño de pautas alimentarias dirigidas a la prevención o al tratamiento de la obesidad o el sobrepeso.

This study is a consensus document of two Spanish scientific associations, FESNAD (Spanish Federation of Nutrition, Food and Dietetic Associations) and SEEDO (Spanish Association for the Study of Obesity), about the role of the diet in the treatment of overweight and obesity in adults. It is the result of a careful and systematic review of the data published in the medical literature from January 1st 1996 to January 31st 2011 concerning the role of the diet on obesity treatment. The achieved conclusions have been classified into various evidence levels. Subsequently in agreement with these evidence levels, different degree recommendations are established being potentially useful to design food guides as part of strategies addressed to the treatment overweight and obesity.

This study is a consensus document of two Spanish scientific associations, FESNAD (Spanish Federation of Nutrition, Food and Dietetetic Associations) and SEEDO (Spanish Association for the Study of Obesity), about the role of the diet in the prevention and of overweight and obesity in adults. It is the result of a careful and systematic review of the data published in the medical literature from January 1st 1996 to January 31st 2011 concerning the role of the diet on obesity prevention. The conclusions obtained have been classified according several evidence levels. Subsequently, in agreement with these evidence levels, different degree recommendations are established. These recommendations could be potentially useful to design food guides as part of strategies to prevent overweight and obesity.

The present study is a consensus document of two Spanish scientific associations, FESNAD (Spanish Federation of Societies of Nutrition, Food and Dietetics Associations) and SEEDO (Spanish Association for the Study of Obesity), about the role of the diet in the prevention and treatment of overweight and obesity in adults. In this part of the document the methodology and the classification of levels of evidence are described. In order to reach the strongest evidence possible, a systematic review of 543 medical studies dealing with these issues published in the last 15 years (from January 1st 1996 to January 31st 2011) has been conducted. In the executive summary, along with the obtained evidences, a set of degree-classified recommendations are established. These recommendations could constitute a useful tool to design food guides addressed to the nutritional counseling for obesity and overweight treatment.