Association between type 2 diabetes and depressive symptoms after a 1-year follow-up in an older adult Mediterranean population.

OBJECTIVES: To examine the cross-sectional association between baseline depressive symptoms and the presence of type 2 diabetes (T2D), and its association with glycated hemoglobin (HbA1c) and other metabolic variables, and the prospective association of depressive symptoms and HbA1c after 1 year of follow-up. METHODS: n = 6224 Mediterranean older adults with overweight/obesity and metabolic syndrome (48% females, mean age 64.9 ± 4.9 years) were evaluated in the framework of the PREDIMED-Plus study cohort. Depressive symptoms were assessed using the Beck Depression Inventory-II and HbA1c was used to measure metabolic control. RESULTS: The presence of T2D increased the likelihood of higher levels of depressive symptoms (χ2 = 15.84, p = 0.001). Polynomial contrast revealed a positive linear relationship (χ2 = 13.49, p = 0.001), the higher the depressive symptoms levels, the higher the prevalence of T2D. Longitudinal analyses showed that the higher baseline depressive symptoms levels, the higher the likelihood of being within the HbA1c ≥ 7% at 1-year level (Wald-χ2 = 24.06, df = 3, p < .001, for the full adjusted model). Additionally, depressive levels at baseline and duration of T2D predicted higher HbA1c and body mass index, and lower physical activity and adherence to Mediterranean Diet at 1 year of follow-up. CONCLUSIONS: This study supports an association between T2D and the severity of depressive symptoms, suggesting a worse metabolic control from mild severity levels in the short-medium term, influenced by lifestyle habits related to diabetes care. Screening for depressive symptoms and a multidisciplinary integrative therapeutic approach should be ensured in patients with T2D.

Intensive Weight-Loss Lifestyle Intervention Using Mediterranean Diet and COVID-19 Risk in Older Adults: Secondary Analysis of PREDIMED-Plus Trial.

OBJECTIVES: We tested the effects of a weight-loss intervention encouraging energy-reduced MedDiet and physical activity (PA) in comparison to ad libitum MedDiet on COVID-19 incidence in older adults. DESIGN: Secondary analysis of PREDIMED-Plus, a prospective, ongoing, multicentre randomized controlled trial. SETTING: Community-dwelling, free-living participants in PREDIMED-Plus trial. PARTICIPANTS: 6,874 Spanish older adults (55-75 years, 49% women) with overweight/obesity and metabolic syndrome. INTERVENTION: Participants were randomised to Intervention (IG) or Control (CG) Group. IG received intensive behavioural intervention for weight loss with an energy-reduced MedDiet intervention and PA promotion. CG was encouraged to consume ad libitum MedDiet without PA recommendations. MEASUREMENTS: COVID-19 was ascertained by an independent Event Committee until December 31, 2021. COX regression models compared the effect of PREDIMED-Plus interventions on COVID-19 risk. RESULTS: Overall, 653 COVID-19 incident cases were documented (IG:317; CG:336) over a median (IQR) follow-up of 5.8 (1.3) years (inclusive of 4.0 (1.2) years before community transmission of COVID-19) in both groups. A significantly lowered risk of COVID-19 incidence was not evident in IG, compared to CG (fully-adjusted HR (95% CI): 0.96 (0.81,1.12)). CONCLUSIONS: There was no evidence to show that an intensive weight-loss intervention encouraging energy-reduced MedDiet and PA significantly lowered COVID-19 risk in older adults with overweight/obesity and metabolic syndrome in comparison to ad libitum MedDiet. Recommendations to improve adherence to MedDiet provided with or without lifestyle modification suggestions for weight loss may have similar effects in protecting against COVID-19 risk in older adults with high cardiovascular risks.

Effects of treatment with monacolin K, berberine and coenzyme Q10 on lipid metabolism in patients with moderate cardiovascular risk.

OBJECTIVE: The use of nutritional supplements to treat hypercholesterolemia is gradually increasing, however further studies on their efficacy and safety are required. PATIENTS AND METHODS: The present clinical trial included patients with moderate hypercholesterolemia and cardiovascular risk who were treated either with a nutraceutical preparation containing 3.75mg of monacolin K, 515mg of berberine and 50mg of coenzyme Q10 per tablet (Lipok®) or with a placebo. The clinical and laboratory variables were analyzed at baseline and at three and six months. None of the patients was diabetic, and none was being treated with lipid-lowering drugs or with any other nutritional supplements affecting lipid metabolism. RESULTS: In patients of the intervention group and of the placebo group, baseline LDL-C was 134.7mg/dL (14.4) and 138.7mg/dL (15.2), respectively. At three months after treatment start, LDL-C had decreased by 26.1mg/dL (-32.4 to 19.7) and increased by 4.5mg/dL (-1.5 to 10.5) in the respective groups. In the intervention group, a similar decrease in non-HDL-C and total cholesterol was observed, while no significant changes were observed in either group for HDL-C, triglycerides and lipoprotein(a). A good tolerance and safety profile was observed. CONCLUSION: In conclusion, this study demonstrates that the combination of monacolin K, berberine and coenzyme Q10 is effective and safe for treating hypercholesterolemia in patients with a moderate degree of excess LDL-C and cardiovascular risk.

Clínica e Investigación en Arteriosclerosis, la revista Iberoamericana de lipidologia y riesgo vascular / Clínica e Investigación en Arteriosclerosis, the Iberoamerican journal of lipidology and vascular risk

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Halo effect of a Mediterranean-lifestyle weight-loss intervention on untreated family members' weight and physical activity: a prospective study.

OBJECTIVES: Obesity is subject to strong family clustering. The relatives of participants in weight-loss interventions may also modify their lifestyle and lose weight. The aim of this study was to examine the presence and magnitude of a halo effect in untreated family members of participants enrolled in a randomized, multi-component, lifestyle intervention. METHODS: A total of 148 untreated adult family members of participants in an intensive weight-loss lifestyle intervention (the PREDIMED-Plus study) were included. Changes at 1 and 2 years in body weight, physical activity, and adherence to a traditional Mediterranean diet (MedDiet) were measured. Generalized linear mixed models were used to assess whether the change differed between family members of the intervention group compared to the control. RESULTS: Untreated family members from the intervention group displayed a greater weight loss than those from the control after 1 and 2 years: adjusted 2-year weight change difference between groups was -3.98 (SE 1.10) kg (p < 0.001). There was a halo effect with regard to adherence to the MedDiet at one year which was sustained at two years: 2-year adjusted difference in MedDiet score change +3.25 (SE 0.46) (p < 0.001). In contrast, no halo effect was observed with regard to physical activity, as the untreated family members did not substantially modify their physical activity levels in either group, and the adjusted difference at two years between the 2 groups was -272 (SE 624) METs.min/week (p = 0.665). CONCLUSIONS: In the first prospective study to assess the influence on untreated family members of a diet and physical activity weight-loss intervention, we found evidence of a halo effect in relatives on weight loss and improvement in adherence to a MedDiet, but not on physical activity. The expansion of MedDiet changes from individuals involved in a weight-loss intervention to their family members can be a facilitator for obesity prevention.

Health-related quality of life in individuals with metabolic syndrome: a cross-sectional study / Calidad de vida relacionada con la salud en individuos con síndrome metabólico: un estudio descriptivo

INTRODUCTION AND OBJECTIVES: Metabolic syndrome (MetS) is a combination of various cardiovascular risk factors with a major impact on morbidity and premature mortality. However, the impact of MetS on self-reported health-related quality of life (HRQoL) is unknown. This study evaluated the HRQoL in a Spanish adult population aged 55 years and older with MetS. METHOD: A cross-sectional analysis was performed with baseline data from the PREDIMED-Plus multicentre randomized trial. The participants were 6430 men and women aged 55-75 years with overweight/obesity (body mass index ≥27 and ≤40kg/m2) and MetS. The SF-36 questionnaire was used as a tool to measure HRQoL. Scores were calculated on each scale of the SF-36 by gender and age. RESULTS: Participants showed higher scores in the social function (mean 85.9, 95% CI; 85.4-86.4) and emotional role scales (mean 86.8, 95% CI; 86.0-87.5). By contrast, the worst scores were obtained in the aggregated physical dimensions. In addition, men obtained higher scores than women on all scales. Among men, the worst score was obtained in general health (mean 65.6, 95% CI; 65.0-66.2), and among women, in body pain (mean 54.3, 95%CI; 53.4-55.2). A significant decrease was found in the aggregated physical dimensions score among participants 70-75 years old, but an increased one in the aggregated mental dimensions, compared to younger participants. CONCLUSIONS: Our results reflect that the MetS may negatively affect HRQoL in the aggregated physical dimensions, body pain in women, and general health in men. However, this adverse association was absent for the psychological dimensions of HRQoL, which were less affected

INTRODUCCIÓN Y OBJETIVOS: El síndrome metabólico (SM) es la combinación de diversos factores de riesgo cardiovascular que pueden derivar en un mayor impacto en la morbimortalidad prematura. Sin embargo, el impacto del SM en la calidad de vida relacionada con la salud (CVRS) es desconocido. El objetivo de este estudio es evaluar la CVRS en la población adulta española de 55 años o más con SM. MÉTODOS: Se realizó un análisis transversal con los datos del ensayo PREDIMED-Plus. Seis mil cuatrocientos treinta varones y mujeres entre 55-75 años con sobrepeso/obesidad y SM. El instrumento de medida de la CVRS fue el cuestionario SF-36. Cada escala del SF-36 fue descrita y estratificada por sexo. RESULTADOS: Los participantes mostraron valores más altos en las escalas función social (media: 85,9; IC 95%: 85,4-86,4) y rol emocional (media: 86,8; IC 95%: 86,0-87,5). En los varones, la peor puntuación fue en la dimensión salud general (media: 65,6; IC 95%: 65,0-66,2) y en las mujeres el dolor corporal (media: 54,3; IC 95%: 53,4-55,2). Además, los varones obtuvieron puntuaciones más altas en todas las escalas. En la escala función física en varones se encontró una disminución significativa de la CVRS en los participantes entre 70 y 75 años en comparación con los más jóvenes. Las peores puntuaciones se obtuvieron en las dimensiones físicas agregadas. CONCLUSIONES: El SM afecta de manera negativa a la CVRS en las dimensiones agregadas físicas, haciendo especial hincapié en la esfera dolor corporal en mujeres y salud general en varones. Sin embargo, las esferas psicológicas se encuentran menos afectadas por el SM

Health-related quality of life in individuals with metabolic syndrome: A cross-sectional study.

INTRODUCTION AND OBJECTIVES: Metabolic syndrome (MetS) is a combination of various cardiovascular risk factors with a major impact on morbidity and premature mortality. However, the impact of MetS on self-reported health-related quality of life (HRQoL) is unknown. This study evaluated the HRQoL in a Spanish adult population aged 55 years and older with MetS. METHOD: A cross-sectional analysis was performed with baseline data from the PREDIMED-Plus multicentre randomized trial. The participants were 6430 men and women aged 55-75 years with overweight/obesity (body mass index ≥27 and ≤40kg/m2) and MetS. The SF-36 questionnaire was used as a tool to measure HRQoL. Scores were calculated on each scale of the SF-36 by gender and age. RESULTS: Participants showed higher scores in the social function (mean 85.9, 95% CI; 85.4-86.4) and emotional role scales (mean 86.8, 95% CI; 86.0-87.5). By contrast, the worst scores were obtained in the aggregated physical dimensions. In addition, men obtained higher scores than women on all scales. Among men, the worst score was obtained in general health (mean 65.6, 95% CI; 65.0-66.2), and among women, in body pain (mean 54.3, 95%CI; 53.4-55.2). A significant decrease was found in the aggregated physical dimensions score among participants 70-75 years old, but an increased one in the aggregated mental dimensions, compared to younger participants. CONCLUSIONS: Our results reflect that the MetS may negatively affect HRQoL in the aggregated physical dimensions, body pain in women, and general health in men. However, this adverse association was absent for the psychological dimensions of HRQoL, which were less affected.

Psychometric properties of the Weight Locus of Control Scale (MWLCS): study with Spanish individuals of different anthropometric nutritional status.

INTRODUCTION: The Multidimensional Weight Locus of Control Scale (MWLCS) measures a person's beliefs regarding the locus of control or lack of locus of control over his/her body weight. PURPOSE: We aim to evaluate the factorial structure and psychometric properties of the MWLCS with Spanish normal weight, overweight and obese samples. METHODS: The research was carried out in two different studies. The first included a sample of 140 normal weight participants, selected out of a 274 sample recruited with an online survey. Study 2 was carried out in a sample of 633 participants recruited from the PREDIMED-Plus study. Out of them, 558 participants fulfilled the weight criteria and were categorized into: overweight (BMI 25 - < 29.99; N = 170), obese class I (BMI 30 - < 34.99; N = 266), and obese class II (BMI 35 - < 39.99; N = 122). Exploratory (EFA) and confirmatory (CFA) factor analyses were used to evaluate the factor structure of the MWLCS, and reliabilities and Spearman's correlations were estimated. Invariance measurement was tested across the three subgroups of weight in Study 2. RESULTS: A three-factor structure indicating weight locus of control factors (internal, chance, and powerful others) was supported, both via EFA in the normal weight sample and CFA in the overweight and obese samples. In the normal weight sample, the powerful others dimension was positively related to BMI and the dimensions of the Dutch Eating Behaviors Questionnaire. Additionally, the scale showed evidence of scalar invariance across the groups with different weight conditions. CONCLUSIONS: This scale seems to be a psychometrically appropriate instrument and its use is highly recommended when designing interventions for overweight or obese individuals. LEVEL OF EVIDENCE: Level V, descriptive study.

Longitudinal changes in Mediterranean diet and transition between different obesity phenotypes.

BACKGROUND & AIMS: Little is known about the impact of specific dietary patterns on the development of obesity phenotypes. We aimed to determine the association of longitudinal changes in adherence to the traditional Mediterranean diet (MedDiet) with the transition between different obesity phenotypes. METHODS: Data of 5801 older men and women at high cardiovascular risk from PREDIMED trial were used. Adherence to MedDiet was measured with the validated 14p-Mediterranean Diet Adherence Screener (MEDAS). Using the simultaneous combination of metabolic health- and body size-related parameters participants were categorized into one of four phenotypes: metabolically healthy and abnormal obese (MHO and MAO), metabolically healthy and abnormal non-obese (MHNO and MANO). Cox regression models with yearly repeated measures during 5-year of follow-up were built with use of Markov chain assumption. RESULTS: Each 2-point increase in MEDAS was associated with the following transitions: in MAO participants, with a 16% (95% CI 3-31%) greater likelihood of becoming MHO; in MHO participants with a 14% (3-23%) lower risk of becoming MAO; in MHNO participants with a 18% (5-30%) lower risk of becoming MHO. In MANO women, but not in men, MEDAS was associated with 20% (5-38%) greater likely of becoming MHNO (p for interaction by gender 0.014). No other significant associations were observed. CONCLUSIONS: Better adherence to the traditional MedDiet is associated with transitions to healthier phenotypes, promoting metabolic health improvement in MAO, MANO (only in women), and MHO, as well as protecting against obesity incidence in MHNO subjects.

Nuevas perspectivas en el tratamiento de la hipercolesterolemia desde la disponibilidad de los inhibidores de la proteína PCSK9 / New perspectives in the treatment of hypercholesterolaemia since the availability of PCSK9 inhibitors

Los grandes ensayos clínicos de prevención cardiovascular han demostrado que cuanto más se disminuye el colesterol aterogénico, mayor es el beneficio preventivo, sin que se haya observado un valor umbral por debajo del cual desparezca dicho efecto o se observen efectos negativos para la salud. Por ello, los objetivos de control de la hipercolesterolemia en los pacientes de alto riesgo cardiovascular son cada vez más estrictos. El hecho de que la mayoría de pacientes de alto riesgo no alcancen dichos objetivos hace necesario, entre otras medidas, un uso racional de los fármacos hipolipemiantes disponibles, incluyendo los anticuerpos monoclonales inhibidores de la proteína PCSK9 (iPCSK9). Los iPCSK9 actualmente autorizados para uso clínico, evolocumab y alirocumab, han demostrado una alta potencia para disminuir el colesterolLDL, que puede superar el 60%, y otros efectos favorables sobre el perfil lipídico, incluyendo una disminución también muy acusada del colesterol-noHDL y de la apolipoproteínaB. Así mismo, mediante ensayos clínicos a gran escala ambos fármacos han demostrado un efecto preventivo frente a las enfermedades cardiovasculares y un alto grado de seguridad. Además, en el caso del alirocumab se ha observado una disminución de la mortalidad por todas las causas. Sin embargo, el elevado coste de los iPCSK9 hace necesario ceñir sus indicaciones a los pacientes de mayor riesgo cardiovascular que no puedan controlarse con estatinas de alta potencia y ezetimiba. Es de esperar que las nuevas guías que serán emitidas en un futuro cercano por distintas sociedades científicas definan con mayor detalle en qué pacientes y en qué condiciones pueden utilizarse los iPCSK9, unos agentes que en este momento constituyen el avance más importante de la terapia hipocolesterolemiante de las últimas décadas

The large clinical trials on cardiovascular prevention have demonstrated that the more atherogenic cholesterol is reduced the greater the preventive benefit, and neither a threshold value below which that effect disappears nor negative effects on health have been observed. Therefore, the objectives of hypercholesterolaemia control in patients at high cardiovascular risk are becoming ever stricter. The fact that most high-risk patients do not achieve these objectives requires, among other measures, rational use of available lipid-lowering drugs, including monoclonal antibodies that inhibit the protein PCSK9 (PCSK9i). The PCSK9i that are currently licensed for clinical use, evolocumab and alirocumab, have shown high potency in lowering LDL-cholesterol, which can exceed 60%, and other favourable effects on lipid profiles, including a very marked reduction of non-HDL cholesterol and apolipoproteinB. Likewise, through large-scale clinical trials, both drugs have demonstrated a preventive effect against cardiovascular diseases, and a high degree of safety. In addition, in the case of alirocumab, a reduction in all-cause mortality has been observed. However, the high cost of the PCSK9i means that prescription is restricted to patients at highest cardiovascular risk who cannot be controlled with high-potency statins and ezetimibe. It is to be hoped that the new guidelines that are to be issued soon by various scientific societies will define in greater detail the patients and the conditions in which we can use PCSK9i, drugs which currently constitute the greatest advance in hypercholesterolaemia of recent decades

[New perspectives in the treatment of hypercholesterolaemia since the availability of PCSK9 inhibitors]. / Nuevas perspectivas en el tratamiento de la hipercolesterolemia desde la disponibilidad de los inhibidores de la proteína PCSK9.

The large clinical trials on cardiovascular prevention have demonstrated that the more atherogenic cholesterol is reduced the greater the preventive benefit, and neither a threshold value below which that effect disappears nor negative effects on health have been observed. Therefore, the objectives of hypercholesterolaemia control in patients at high cardiovascular risk are becoming ever stricter. The fact that most high-risk patients do not achieve these objectives requires, among other measures, rational use of available lipid-lowering drugs, including monoclonal antibodies that inhibit the protein PCSK9 (PCSK9i). The PCSK9i that are currently licensed for clinical use, evolocumab and alirocumab, have shown high potency in lowering LDL-cholesterol, which can exceed 60%, and other favourable effects on lipid profiles, including a very marked reduction of non-HDL cholesterol and apolipoproteinB. Likewise, through large-scale clinical trials, both drugs have demonstrated a preventive effect against cardiovascular diseases, and a high degree of safety. In addition, in the case of alirocumab, a reduction in all-cause mortality has been observed. However, the high cost of the PCSK9i means that prescription is restricted to patients at highest cardiovascular risk who cannot be controlled with high-potency statins and ezetimibe. It is to be hoped that the new guidelines that are to be issued soon by various scientific societies will define in greater detail the patients and the conditions in which we can use PCSK9i, drugs which currently constitute the greatest advance in hypercholesterolaemia of recent decades.

Mediterranean alcohol-drinking pattern, low to moderate alcohol intake and risk of atrial fibrillation in the PREDIMED study.

BACKGROUND AND AIMS: There is ongoing controversy about the effect of a low to moderate alcohol consumption on atrial fibrillation (AF). Our aim is to assess the association between adherence to a Mediterranean alcohol drinking pattern and AF incidence. METHODS AND RESULTS: A total 6527 out of the 7447 participants in the PREDIMED trial met our inclusion criteria. A validated frequency food questionnaire was used to measure alcohol consumption. Participants were classified as non-drinkers, Mediterranean alcohol drinking pattern (MADP) (10-30 g/d in men and 5-15 g/day in women, preferably red wine consumption with low spirits consumption), low-moderate drinking (<30 g/day men y and < 15 g/day women), and heavy drinking. We performed multivariable Cox regression models to estimate hazard ratios (HR) with 95% confidence intervals (95% CI) of incident AF according to alcohol drinking patterns. After a mean follow up of 4.4 years, 241 new incident AF cases were confirmed. Alcohol consumption was not associated to AF incidence among low-moderate drinkers (HR: 0.96; 95%CI: 0.67-1.37), adherents to MADP (HR: 1.15 95%CI: 0.75-1.75), or heavy drinkers (HR: 0.92; 95%CI: 0.53-1.58), compared with non-drinkers. CONCLUSIONS: In a high cardiovascular risk adult population, a Mediterranean alcohol consumption pattern (low to moderate red wine consumption) was not associated with an increased incidence of AF. CLINICAL TRIALS: URL: http://www.controlled-trials.com. Unique identifier: ISRCTN35739639.

Fermented dairy products, diet quality, and cardio-metabolic profile of a Mediterranean cohort at high cardiovascular risk.

BACKGROUND AND AIMS: Fermented dairy products have been associated with a better diet quality and cardio-metabolic profile. However, in Mediterranean populations, these associations have not been well characterized. The aim of this study was to assess the diet quality and the associations between the consumption of total fermented dairy products and their subtypes and the prevalence of Metabolic Syndrome (MetS) components in a Mediterranean population at high cardiovascular risk. METHODS AND RESULTS: Baseline cross-sectional analyses were conducted on 6,572 men and women (mean age: 65 years) with overweight or obesity and MetS recruited into the PREDIMED-Plus cohort. A 143-item Food Frequency Questionnaire (FFQ) was used, and anthropometrical, biochemical, and blood pressure measurements were recorded. Multivariate-adjusted Cox regressions were fitted to analyze the association between quartiles of consumption of fermented dairy products and their subtypes and MetS components to estimate the relative risk (RR) and 95% confidence intervals (95% CIs). Participants who were high consumers of fermented dairy products reported a higher consumption of fruit, vegetables, fish, nuts, and whole bread and a lower consumption of white bread, alcohol, and cookies. Participants in the higher quartile showed a lower prevalence of the low HDL-cholesterol component of the MetS (RR=0.88; 95% CI: 0.78-0.98) than those in the lowest quartile of cheese consumption. Cheese consumption was inversely associated with the prevalence of hypertriglyceridemia. Total fermented dairy products, yogurt, and its types were not associated with any of the MetS components. CONCLUSIONS: Compared to nonconsumers, participants consuming fermented dairy products reported a better diet quality and, particularly, cheese consumers presented a lower prevalence of hypertriglyceridemia and low HDL-cholesterol plasma levels, which are MetS components.

Omega-3 fatty acids as adjunctive treatment for bexarotene-induced hypertriglyceridaemia in patients with cutaneous T-cell lymphoma.

BACKGROUND: Bexarotene is an oral retinoid approved for treating cutaneous T-cell lymphoma (CTCL) in patients resistant to first-line systemic treatment. Hypertriglyceridaemia is an unavoidable adverse effect of bexarotene therapy, and requires monitoring because of the risk of developing pancreatitis. Therefore, prophylactic hypolipidaemic therapy, usually with a fibrate alone, is required for preventing bexarotene-induced hypertriglyceridaemia. Despite these measures, a large number of patients develop very severe hypertriglyceridaemia. AIM: To assess the lipid metabolism changes before and after the use of a combination of omega-3 fatty acids (n-3 FA) plus fenofibrate compared with fenofibrate alone as a more effective lipid-lowering therapy in patients with CTCL treated with bexarotene. METHODS: From January 2005 to January 2013, we analysed all 25 patients with CTCL treated with bexarotene. The first 18 consecutively enrolled patients received fenofibrate alone as a lipid-lowering therapy, and the next 7 consecutively enrolled patients received a combination of fenofibrate and n-3 FA. RESULTS: Data for all 25 consecutive patients with CTCL treated with bexarotene were evaluated. Of these, 24 patients (96%) developed hypertriglyceridaemia despite the hypolipidaemic therapy, with this being very severe (> 11.2 mmol/L) in 20% of the cases. Of the 18 patients receiving fenofibrate alone, 5 (28%) developed very severe hypertriglyceridaemia, compared with none of the 7 patients treated with the n-3 FA combination. CONCLUSIONS: Our results suggest that the n-3 FA combination may be more effective than fibrate alone for preventing bexarotene-induced hypertriglyceridaemia.

Egg consumption and cardiovascular disease according to diabetic status: The PREDIMED study.

BACKGROUND: Eggs are a major source of dietary cholesterol and their consumption has been sometimes discouraged. A relationship between egg consumption and the incidence of cardiovascular disease (CVD) has been suggested to be present exclusively among patients with type2 diabetes. AIMS: To assess the association between egg consumption and CVD in a large Mediterranean cohort where approximately 50% of participants had type 2 diabetes. METHODS: We prospectively followed 7216 participants (55-80 years old) at high cardiovascular risk from the PREDIMED (PREvención con DIeta MEDiterránea) study for a mean of 5.8 years. All participants were initially free of CVD. Yearly repeated measurements of dietary information with a validated 137-item food-frequency questionnaire were used to assess egg consumption and other dietary exposures. The endpoint was the rate of major cardiovascular events (myocardial infarction, stroke or death from cardiovascular causes). RESULTS: A major cardiovascular event occurred in 342 participants. Baseline egg consumption was not significantly associated with cardiovascular events in the total population. Non-diabetic participants who ate on average >4 eggs/week had a hazard ratio (HR) of 0.96 (95% confidence interval, 0.33-2.76) in the fully adjusted multivariable model when compared with non-diabetic participants who reported the lowest egg consumption (<2 eggs/week). Among diabetic participants, the HR was 1.33 (0.72-2.46). There was no evidence of interaction by diabetic status. HRs per 500 eggs of cumulative consumption during follow-up were 0.94 (0.66-1.33) in non-diabetics and 1.18 (0.90-1.55) in diabetics. CONCLUSIONS: Low to moderated egg consumption was not associated with an increased CVD risk in diabetic or non-diabetic individuals at high cardiovascular risk. This trial was registered at controlled-trials.com as ISRCTN35739639.

Yogurt consumption and abdominal obesity reversion in the PREDIMED study.

BACKGROUND AND AIMS: Evidence on the association yogurt consumption and obesity is not conclusive. The aim of this study was to prospectively evaluate the association between yogurt consumption, reversion of abdominal obesity status and waist circumference change in elderly. METHODS AND RESULTS: 4545 individuals at high cardiovascular risk were prospectively followed. Total, whole-fat and low-fat yogurt consumption were assessed using food frequency questionnaires. Generalized estimating equations were used to analyze the association between yogurt consumption and waist circumference change (measured at baseline and yearly during the follow-up). Logistic regression models were used to evaluate the odds ratios (ORs) and 95% CIs of the reversion rate of abdominal obesity for each quintile of yogurt consumption compared with the lowest quintile. After multivariable adjustment, the average yearly waist circumference change in the quintiles of whole-fat yogurt consumption was: Q1: 0.00, Q2: 0.00 (-0.23 to 0.23), Q3: -0.15 (-0.42 to 0.13), Q4: 0.10 (-0.21 to 0.42), and Q5: -0.23 (-0.46 to -0.00) cm; p for trend = 0.05. The ORs for the reversion of abdominal obesity for whole-fat yogurt consumption were Q1: 1.00, Q2: 1.40 (1.04-1.90), Q3: 1.33 (0.94-1.89), Q4: 1.21 (0.83-1.77), and Q5: 1.43 (1.06-1.93); p for trend = 0.26. CONCLUSION: Total yogurt consumption was not significantly associated with reversion of abdominal obesity status and a lower waist circumference. However, consumption of whole-fat yogurt was associated with changes in waist circumference and higher probability for reversion of abdominal obesity. Therefore, it seems that whole-fat yogurt has more beneficial effects in management of abdominal obesity in elderly population at high cardiovascular risk.

Erectile dysfunction and cardiovascular risk factors in a Mediterranean diet cohort.

BACKGROUND: Erectile dysfunction affects more than 100 million men worldwide, with a wide variability in prevalence. An overall association of cardiovascular risk factors, lifestyle and diet in the context of ED in a Mediterranean population is lacking. AIM: To assess ED prevalence and associated factors in a Mediterranean cohort of non-diabetic patients with cardiovascular risk factors. METHODS: Observational, cross-sectional study of patients aged over 40 treated at cardiovascular risk units in Catalonia. Anthropometric data, risk factors, lifestyle and diet habits were recorded. ED was assessed using the International Index of Erectile Function. RESULTS: Four hundred and forty patients included, 186 (42.3%) with ED (24.8% mild, 6.8% moderate and 10.7% severe). ED presence and severity were associated with age, obesity, waist circumference, hypertension, antihypertensive treatment and ischaemic disease. Patients with ED were more frequently smokers, sedentary and consumed more alcohol. In multivariate analysis, consumption of nuts (> twice a week) (OR 0.41 (95% CI 0.25 to 0.67) and vegetables (≥ once a day) (OR 0.47 (95% CI 0.28-0,77)), were inversely related to ED. Obesity (as BMI ≥ 30 kg/m(2) ) (OR 2.49 (95% CI 1.48-4.17)), ischaemic disease (OR 2.30 (95% CI 1.22 to 4.33), alcohol consumption (alcohol-units a day) (OR 1.14 (95% CI 1.04 to 1.26), and age (year) (OR = 1.07 (95% CI 1.04-1.10) were directly related to ED. CONCLUSION: Erectile dysfunction is a common disorder in patients treated in lipid units in Catalonia for cardiovascular risk factors. This condition is associated with age, obesity, ischaemic disease and unhealthy lifestyle habits.

Dietary total antioxidant capacity and mortality in the PREDIMED study.

PURPOSE: The aim of the present study was to assess the association between the dietary total antioxidant capacity, the dietary intake of different antioxidants and mortality in a Mediterranean population at high cardiovascular disease risk. METHODS: A total of 7,447 subjects from the PREDIMED study (multicenter, parallel group, randomized controlled clinical trial), were analyzed treating data as an observational cohort. Different antioxidant vitamin intake and total dietary antioxidant capacity were calculated from a validated 137-item food frequency questionnaire at baseline and updated yearly. Deaths were ascertained through contact with families and general practitioners, review of medical records and consultation of the National Death Index. Cox regression models were fitted to assess the relationship between dietary total antioxidant capacity and mortality. Dietary total antioxidant capacity was estimated using ferric-reducing antioxidant power assays. RESULTS: A total of 319 deaths were recorded after a median follow-up of 4.3 years. Subjects belonging to the upper quintile of antioxidant capacity were younger, ex-smokers, with high educational level, and more active and had higher alcohol intake. Multivariable-adjusted models revealed no statistically significant difference between total dietary antioxidant capacity and mortality (Q5 vs. Q1 ref HR 0.85; 95% CI 0.60-1.20) neither for the intake of all the vitamins studied. CONCLUSIONS: No statistically significant association was found between antioxidant capacity and total mortality in elderly subjects at high cardiovascular risk.