Elevated Lipoprotein(a) prevalence and association with family history of premature cardiovascular disease in general population with moderate cardiovascular risk and increased LDL cholesterol.

Background: Elevated Lipoprotein(a) [Lp(a)] is independently associated with increased cardiovascular disease (CVD) risk. There are discrepancies regarding its epidemiology due to great variability in different populations. This study aimed to evaluate the prevalence of elevated Lp(a) in people with moderate CVD risk and increased LDL-c and to determine the association between family history of premature CVD and elevated Lp(a). Methods: Random subjects from the CESCAS population-based study of people with moderate CVD risk (Framingham score 10-20 %) and LDL-c ≥ 130 mg/dL, were selected to evaluate Lp(a) by immunoturbidimetry independent of the Isoforms variability. The association between family history of premature CVD and elevated Lp(a) was evaluated using multivariate logistic regression models. Elevated Lp(a) was defined as Lp(a) ​​≥ 125 nmol/L. Results: Lp(a) was evaluated in 484 samples; men = 39.5 %, median age = 57 years (Q1-Q3: 50-63), mean CVD risk = 14.4 % (SE: 0.2), family history of premature CVD = 11.2 %, Lp(a) median of 21 nmol/L (Q1-Q3: 9-42 nmol/L), high Lp(a) = 6.1 % (95 % CI = 3.8-9.6). Association between family history of premature CVD and elevated Lp(a) in total population: OR 1.31 (95 % CI = 0.4, 4.2) p = 0.642; in subgroup of people with LDL-c ≥ 160 mg%, OR 4.24 (95 % CI = 1.2, 15.1) p = 0.026. Conclusions: In general population with moderate CVD risk and elevated LDL-c from the Southern Cone of Latin America, less than one over ten people had elevated Lp(a). Family history of premature CVD was significantly associated with the presence of elevated Lp(a) in people with LDL-c ≥ 160 mg/dL.

Adherence to Drinking Guidelines and Reasons for Alcohol Consumption Cessation in the Southern Cone of Latin America - Findings from the CESCAS Study.

Introduction: Alcohol consumption is a risk factor for morbidity and mortality globally. Consumption levels in Southern Latin America are among the highest in the world. Objectives: To describe consumption patterns and adherence to guidelines in the general adult population of Southern Latin America, as well as exploration of reasons for alcohol cessation and the advising role of the health worker in this decision. Methods: In 7,520 participants from the Centro de Excelencia en Salud Cardiovascular para el America del Sur (CESCAS) cohort, consumption patterns were described and the proportion excessive drinkers (i.e. >7 units/week for women and >14 for men or binge drinking: >4 (women) or >5 (men) units at a single occasion) was calculated. Former drinkers were asked if they had quit alcohol consumption on the advice of a health worker and/or because of health reasons. Furthermore, among former drinkers, multivariable logistic regression analysis was performed to assess which participant characteristics were independently associated with the chance of quitting consumption on a health worker's advice. Results: Mean age was 54.8 years (SD = 10.8), 42% was male. Current drinking was reported by 44.6%, excessive drinking by 8.5% of the population. In former drinkers, 23% had quit alcohol consumption because of health reasons, half of them had additionally quit on the advice of a health worker. The majority of former drinkers however had other, unknown, reasons. When alcohol cessation was based on a health worker's advice, sex, country of residence, educational status and frequency of visiting a physician were independent predictors. Conclusion: In this Southern American population-based sample, most participants adhered to the alcohol consumption guidelines. The advising role of the health worker in quitting alcohol consumption was only modest and the motivation for the majority of former drinkers remains unknown. A more detailed assessment of actual advice rates and exploration of additional reasons for alcohol cessation might be valuable for alcohol policy making.

Short-course Benznidazole treatment to reduce Trypanosoma cruzi parasitic load in women of reproductive age (BETTY): a non-inferiority randomized controlled trial study protocol.

BACKGROUND: Retrospective observational studies suggest that transmission of Trypanosoma cruzi does not occur in treated women when pregnant later in life. The level of parasitemia is a known risk factor for congenital transmission. Benznidazole (BZN) is the drug of choice for preconceptional treatment to reduce parasitic load. The fear of treatment-related side effects limits the implementation of the Argentine guideline recommending BZN 60d/300 mg (or equivalent) treatment of T. cruzi seropositive women during the postpartum period to prevent transmission in a future pregnancy. A short and low dose BZN treatment might reduce major side effects and increase compliance, but its efficacy to reduce T. cruzi parasitic load compared to the standard 60d/300 mg course is not yet established. Clinical trials testing alternative BZN courses among women of reproductive age are urgently needed. METHODS AND DESIGN: We are proposing to perform a double-blinded, non-inferiority randomized controlled trial comparing a short low dose 30-day treatment with BZN 150 mg/day (30d/150 mg) vs. BZN 60d/300 mg. We will recruit not previously treated T. cruzi seropositive women with a live birth during the postpartum period in Argentina, randomize them at 6 months postpartum, and follow them up with the following specific aims: Specific aim 1: to measure the effect of BZN 30d/150 mg compared to 60d/300 mg preconceptional treatment on parasitic load measured by the frequency of positive Polymerase Chain Reaction (PCR) (primary outcome) and by real-time quantitative PCR (qPCR), immediately and 10 months after treatment. Specific aim 2: to measure the frequency of serious adverse events and/or any adverse event leading to treatment interruption. TRIAL REGISTRATION: ClinicalTrials.gov . Identifier: NCT03672487 . Registered 14 September 2018.

The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk.

BACKGROUND: Observational studies have documented lower risks of coronary heart disease and diabetes among moderate alcohol consumers relative to abstainers, but only a randomized clinical trial can provide conclusive evidence for or against these associations. AIM: The purpose of this study was to describe the rationale and design of the Moderate Alcohol and Cardiovascular Health Trial, aimed to assess the cardiometabolic effects of one alcoholic drink daily over an average of six years among adults 50 years or older. METHODS: This multicenter, parallel-arm randomized trial was designed to compare the effects of one standard serving (∼11-15 g) daily of a preferred alcoholic beverage to abstention. The trial aimed to enroll 7800 people at high risk of cardiovascular disease. The primary composite endpoint comprised time to the first occurrence of non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalized angina, coronary/carotid revascularization, or total mortality. The trial was designed to provide >80% power to detect a 15% reduction in the risk of the primary outcome. Secondary outcomes included diabetes. Adverse effects of special interest included injuries, congestive heart failure, alcohol use disorders, and cancer. RESULTS: We describe the design, governance, masking issues, and data handling. In three months of field center activity until termination by the funder, the trial randomized 32 participants, successfully screened another 70, and identified ∼400 additional interested individuals. CONCLUSIONS: We describe a feasible design for a long-term randomized trial of moderate alcohol consumption. Such a study will provide the highest level of evidence for the effects of moderate alcohol consumption on cardiovascular disease and diabetes, and will directly inform clinical and public health guidelines.

An Educational Intervention to Improve Statin Use: Cluster RCT at the Primary Care Level in Argentina.

INTRODUCTION: Statins are essential drugs for high cardiovascular disease (CVD) risk management; however, there is still low adherence to good clinical practice guidelines for statin use at the primary care level in low- and middle-income countries. This study aimed to test whether a complex intervention targeting physicians improves treatment and control of hypercholesterolemia among patients with moderate to high CVD risk in Argentina. STUDY DESIGN: Cluster RCT. SETTING/PARTICIPANTS: Ten primary care centers from the public healthcare system of Argentina. INTERVENTION: Primary care physicians in the intervention group received an educational program with three main components: (1) an intensive 2-day training workshop; (2) educational outreach visits; and (3) a mobile health application installed on the physician's smartphones. MAIN OUTCOME MEASURES: Reduction in mean low-density lipoprotein cholesterol level, reduction in mean Framingham risk score, proportion of patients receiving an appropriate statin dose, and mean annual number of primary care center visits. RESULTS: Data were analyzed in 2017-2018. Between April 2015 and April 2016, a total of 357 participants were enrolled (179 patients in the intervention group and 178 in the control group). The global follow-up rate was 97.2%. At the end of the follow-up period, there was no difference in low-density lipoprotein cholesterol levels in any of the follow-up points among the groups. Mean CVD risk had a significant net difference in the first 6 months in the intervention group versus the control group (-4.0, 95% CI = -6.5, -1.5). At the end of follow-up, there was an absolute 41.5% higher rate of participants receiving an appropriate statin dose in the intervention group versus the control group. CONCLUSIONS: Although the intervention did not reach a reduction in cholesterol levels, it had a significant positive impact on the promotion of adequate use of clinical practice guidelines. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT02380911.

Adolescentes Libres de Tabaco: Efectividad de una intervención educativa. Estudio antes-después controlado / Smoke-Free Adolescents: Effectiveness of an educational intervention. Controlled, before and after study

El tabaquismo es considerado la principal causa de muerte prevenible en el mundo. La mayoría de los fumadores inician esta adicción durante edades tempranas, especialmente, durante la adolescencia. El objetivo del estudio fue identificar los determinantes de consumo adolescente y evaluar el impacto de una intervención educativa en la prevalencia del tabaquismo. Métodos. Estudio antes-después controlado, realizado durante los años 2010-2012 en dos colegios secundarios de la ciudad de La Plata. En ambos, se realizó una encuesta basal seguida de dos mediciones posteriores; en uno de ellos, se implementó una intervención educativa dirigida a jóvenes de 12 y 13 años. Se utilizaron modelos de regresión múltiple para identificar las variables asociadas al tabaquismo y evaluar el impacto de la intervención. Resultados. Se incluyeron 1911 encuestas (Colegio A: 617; Colegio B: 1294). Las variables asociadas al tabaquismo adolescente fueron la tenencia de un hermano fumador (odds ratio -OR- 2,55), madre fumadora (OR 2,32), años de edad (OR 1,92) y el sexo femenino (OR 1,75). El OR ajustado por dichos determinantes para ser fumador actual en el colegio intervención versus el control fue 0,54 (intervalo de confianza -IC- del 95%: 0,35-0,83) en el primer año de seguimiento y 0,98 (IC 95%: 0,60-1,61) en el segundo año. Conclusiones. La tenencia de una madre o un hermano fumador, la edad y el sexo femenino se correlacionaron fuertemente con el consumo de cigarrillos. La intervención educativa tuvo un efecto positivo en el primer año de seguimiento, pero luego no se mantuvo.

Smoking is considered the main cause of preventable death worldwide. Most smokers start using tobacco at an early age, especially during adolescence. The objective of this study was to identify the determinants of adolescent use of tobacco and assess the impact of an educational intervention on the prevalence of smoking. Methods. Controlled, before and after study conducted between 2010 and 2012 at two secondary schools in the city of La Plata. A baseline survey was administered at both schools followed by two subsequent measurements; an educational intervention aimed at youth aged 12 and 13 years was implemented in one of the schools. Multiple regression models were used to identify the outcome measures associated with smoking and assess the impact of the intervention. Results. A total of 1911 surveys were included (school A: 617; school B: 1294). The outcome measures associated with adolescent smoking were having a sibling who smokes (odds ratio -amp;#91;OR-amp;#93;: 2.55), a mother who smokes (OR: 2.32), age (OR: 1.92), and female sex (OR: 1.75). The OR adjusted for these determinants to be a current smoker at the intervention school versus the control school was 0.54 (95% confidence interval -amp;#91;CI-amp;#93;: 0.35-0.83) in the first year of follow-up and 0.98 (95% CI: 0.60-1.61) in the second year. Conclusions. Having a mother or a sibling who smokes, age, and female sex were strongly correlated to cigarette smoking. The educational intervention had a positive effect in the first year of follow-up, which was not maintained over time.

Smoke-Free Adolescents. Effectiveness of an educational intervention. Controlled, before and after study. / Adolescentes Libres de Tabaco. Efectividad de una intervención educativa. Estudio antes-después controlado.

Smoking is considered the main cause of preventable death worldwide. Most smokers start using tobacco at an early age, especially during adolescence. The objective of this study was to identify the determinants of adolescent use of tobacco and assess the impact of an educational intervention on the prevalence of smoking. Methods. Controlled, before and after study conducted between 2010 and 2012 at two secondary schools in the city of La Plata. A baseline survey was administered at both schools followed by two subsequent measurements; an educational intervention aimed at youth aged 12 and 13 years was implemented in one of the schools. Multiple regression models were used to identify the outcome measures associated with smoking and assess the impact of the intervention. Results. A total of 1911 surveys were included (school A: 617; school B: 1294). The outcome measures associated with adolescent smoking were having a sibling who smokes (odds ratio [OR]: 2.55), a mother who smokes (OR: 2.32), age (OR: 1.92), and female sex (OR: 1.75). The OR adjusted for these determinants to be a current smoker at the intervention school versus the control school was 0.54 (95% confidence interval [CI]: 0.35-0.83) in the first year of follow-up and 0.98 (95% CI: 0.60-1.61) in the second year. Conclusions. Having a mother or a sibling who smokes, age, and female sex were strongly correlated to cigarette smoking. The educational intervention had a positive effect in the first year of follow-up, which was not maintained over time

El tabaquismo es considerado la principal causa de muerte prevenible en el mundo. La mayoría de los fumadores inician esta adicción durante edades tempranas, especialmente, durante la adolescencia. El objetivo del estudio fue identificar los determinantes de consumo adolescente y evaluar el impacto de una intervención educativa en la prevalencia del tabaquismo. Métodos. Estudio antes-después controlado, realizado durante los años 2010-2012 en dos colegios secundarios de la ciudad de La Plata. En ambos, se realizó una encuesta basal seguida de dos mediciones posteriores; en uno de ellos, se implementó una intervención educativa dirigida a jóvenes de 12 y 13 años. Se utilizaron modelos de regresión múltiple para identificar las variables asociadas al tabaquismo y evaluar el impacto de la intervención. Resultados. Se incluyeron 1911 encuestas (Colegio A: 617; Colegio B: 1294). Las variables asociadas al tabaquismo adolescente fueron la tenencia de un hermano fumador (odds ratio ­OR­ 2,55), madre fumadora (OR 2,32), años de edad (OR 1,92) y el sexo femenino (OR 1,75). El OR ajustado por dichos determinantes para ser fumador actual en el colegio intervención versus el control fue 0,54 (intervalo de confianza ­IC­ del 95%: 0,35-0,83) en el primer año de seguimiento y 0,98 (IC 95%: 0,60-1,61) en el segundo año. Conclusiones. La tenencia de una madre o un hermano fumador, la edad y el sexo femenino se correlacionaron fuertemente con el consumo de cigarrillos. La intervención educativa tuvo un efecto positivo en el primer año de seguimiento, pero luego no se mantuvo.

External Validation of Cardiovascular Risk Scores in the Southern Cone of Latin America: Which Predicts Better? / Validación externa de ecuaciones de riesgo cardiovascular en el Cono Sur de Latinoamérica: ¿cuál predice mejor?

ABSTRACT: Background: Inaccurate estimates of demographic cardiovascular risk may lead to an inadequate management of preventive medical interventions such as the use of statins. Objectives: The aim of this study was to evaluate the external validity of cardiovascular risk equations in the general population of the Southern Cone of Latin America. Methods: Equations including variables evaluated in the CESCAS cohort study and that estimate overall cardiovascular mortality (CUORE, Framingham, Globorisk and Pooled Cohort Studies) were assessed. For each equation, an independent analysis was per-formed taking into account the cardiovascular events originally considered. Discrimination of each equation was evaluated through C-statistic and Harrell's C-index. To assess calibration, a graph was built for each equation with the proportion of observed events vs. the proportion of estimated events by risk quintiles and the β slope of the resulting linear regression was calculated. Sensitivity and specificity were determined for the detection of people at high cardiovascular risk. results: The median follow-up time of the cohort at the time of the analysis was 2.2 years, with an interquartile range of 1.9 to 2.8 years. Sixty cardiovascular events were incorporated into the analysis. All C-statistic and Harrell's-C index values were greater than 0.7. The value of the β slope farthest from 1 was that of the Pooled Cohort Studies score. Conclusions: Although the external validation parameters evaluated were similar, CUORE, Globorisk and the Framingham equa-tions showed the best global performance for cardiovascular risk estimation in our population.

RESUMEN: introducción: La estimación inexacta del riesgo cardiovascular poblacional puede llevar a un manejo inadecuado de las intervenciones médicas preventivas, como, por ejemplo, el uso de estatinas. Objetivo: Evaluar la validez externa de ecuaciones de predicción de riesgo cardiovascular en población general del Cono Sur de Latinoamérica. Material y métodos: Se evaluaron ecuaciones que incluyen variables evaluadas en el estudio CESCAS y que predicen tanto morbilidad como mortalidad cardiovascular global (CUORE, Framingham, Globorisk y Pooled Cohort Studies Equations). Para cada ecuación se realizó un análisis independiente en el que se tuvieron en cuenta los eventos cardiovasculares relevados. Se evaluó la discriminación de cada ecuación a través del cálculo del estadístico-C y el índice Harrell C. Para evaluar la calibración se graficó la proporción de riesgos observados vs. estimados por quintilos de riesgo para cada ecuación y se calculó la pendiente β de regresión lineal para las estimaciones. Se calculó sensibilidad y especificidad para la detección de personas con elevado riesgo cardiovascular. resultados: La mediana del tiempo de seguimiento de la cohorte al momento del análisis es de 2,2 años, con un rango intercuartilo de 1,9 a 2,8 años. Se incorporaron a los análisis 60 eventos cardiovasculares. Todos los valores de estadístico-C y del índice de Harrell fueron superiores a 0,7. El valor de la pendiente β más alejado de 1 fue el de Pooled Cohort Studies Euations. Conclusiones: Si bien los parámetros de validación externa evaluados fueron similares, CUORE, Globorisk y el índice de Framing-ham fueron las ecuaciones con mejores indicadores globales de predicción de riesgo cardiovascular.