School environments and obesity: a systematic review of interventions and policies among school-age students in Latin America and the Caribbean.

BACKGROUND: The rapid rise in obesity rates among school children in Latin America and the Caribbean (LAC) could have a direct impact on the region's physical and mental health, disability, and mortality. This review presents the available interventions likely to reduce, mitigate and/or prevent obesity among school children in LAC by modifying the food and built environments within and around schools. METHODS: Two independent reviewers searched five databases: MEDLINE, Web of Science, Cochrane Library, Scopus and Latin American and Caribbean Health Sciences Literature for peer-reviewed literature published from 1 January 2000 to September 2021; searching and screening prospective studies published in English, Spanish and Portuguese. This was followed by data extraction and quality assessment using the Cochrane risk-of-bias tool (RoB 2) and the Risk of Bias in Non-Randomized Studies of Interventions (ROBINS-I), adopting also the PRISMA 2020 guidelines. Due to the heterogeneity of the intervention's characteristics and obesity-related measurements across studies, a narrative synthesis was conducted. RESULTS: A total of 1342 research papers were screened, and 9 studies were included; 4 in Mexico, and 1 each in Argentina, Brazil, Chile, Colombia, and Ecuador. Four studies reported strategies for modifying food provision; four other targeted the built environment, (modifying school premises and providing materials for physical activity); a final study included both food and built environment intervention components. Overall, two studies reported that the intervention was significantly associated with a lower increase over time in BMI/obesity in the intervention against the control group. The remaining studies were non-significant. CONCLUSIONS: Data suggest that school environmental interventions, complementing nutritional and physical education can contribute to reduce incremental childhood obesity trends. However, evidence of the extent to which food and built environment components factor into obesogenic environments, within and around school grounds is inconclusive. Insufficient data hindered any urban/rural comparisons. Further school environmental intervention studies to inform policies for preventing/reducing childhood obesity in LAC are needed.

Diet cost and quality using the Healthy Eating Index-2015 in adults from urban and rural areas of Mexico.

OBJECTIVE: To assess the association between diet cost and quality by place of residence. DESIGN: We analysed cross-sectional data of the National Health and Nutrition Survey-2012. Diet cost was estimated by linking dietary data, obtained from a 7-d SFFQ, with municipality food prices, which were derived from a national expenditure survey. Diet quality was assessed using the Healthy Eating Index-2015 (HEI-2015). Association between quintiles of diet cost and HEI-2015 was assessed using linear regression analysis. SETTINGS: Mexico. PARTICIPANTS: 2438 adults (18-59 years). RESULTS: Diet cost was positively associated with diet quality (HEI-2015) in urban but not in rural areas. Compared with quintile (Q1) of cost, the increment in diet quality score was 1·17 (95 % CI -0·06, 4·33) for Q2, 2·14 (95 % CI -0·06, 4·33) for Q3, 4·70 (95 % CI 2·62, 6·79) for Q4 and 6·34 (95 % CI 4·20, 8·49) for Q5 (P-trend < 0·001). Individuals in rural v. urban areas on average have higher quality diets at lower cost with higher intakes of whole grains and beans and lower intakes of Na, added sugars and saturated fats. Living in the South, being indigenous and having low socio-economic status were also associated with higher quality diets. CONCLUSIONS: Diet cost was positively associated with diet quality, but only in urban areas. Further studies are needed to understand the relation between diet cost and quality in rural areas. To improve overall diet quality in Mexico, strategies that aim to reduce the cost of high-quality diets should consider the heterogeneity by place of residence.

Malnutrition in all its forms and socio-economic disparities in children under 5 years of age and women of reproductive age in Peru.

OBJECTIVE: To compare the distribution of malnutrition by socio-economic indicators (SEI) in Peruvian children under 5 years and women of reproductive age (WRA). DESIGN: We analysed data from the National Demographic and Family Health Survey. WHO criteria were used to define malnutrition indicators (overweight/obesity combined (OW); wasting/underweight; stunting/short stature; anaemia). Linear combination test was used to compare the prevalence of malnutrition by SEI (wealth index as a proxy of socio-economic status (SES); education; ethnicity). Prevalence ratio (PR) was used to describe disparities and associations between malnutrition and SEI. SETTING: Peru (2015). PARTICIPANTS: Children (n 22 833) under 5 years and WRA (n 33 503; 5008 adolescents and 28 495 adults). RESULTS: The most prevalent form of malnutrition was anaemia (32·0 %) in children and OW in adolescent and adult WRA (31·3 and 65·1 %, respectively). Adjusted models showed that stunting and anaemia were significantly lower among children with high SES (PR = 0·25, 0·67), high-educated mothers (PR = 0·26, 0·76) and higher in indigenous children (PR = 1·3, 1·2); conversely, OW was higher among those with high SES and high-educated mothers (PR = 1·8, 1·6) compared with their lowest counterparts. In WRA, stunting/short stature was lower among those with high SES, high education and higher in indigenous adult women. OW in adolescents and adults was higher in high SES (PR = 1·4, 1·1), lower in indigenous adult women (PR = 0·84) and lower in high-educated adult women (PR = 0·86). CONCLUSIONS: In the studied population, the distribution of malnutrition was associated with SEI disparities. Effective policies that integrate actions to overcome the double burden of malnutrition and reduce disparities are needed.

A high density of ultra-processed food, alcohol & tobacco retail stores, and social inequalities are associated with higher mortality rates of non-communicable diseases in Mexican adults: 2005 to 2021.

BACKGROUND: Non-communicable diseases (NCDs) are the leading causes of mortality in Mexico. Factors contributing to NCDs-related deaths may vary across small geographic areas such as municipalities. We aimed to predict municipal-level factors associated with NCD mortality in Mexican adults from 2005 to 2021 using the small-area analysis (SSA) approach. METHODS: We gathered data on population sociodemographic, access to healthcare services, and mortality records at the municipal-level from census and public institutions from 2005 to 2021. We identified municipal predictors of NCDs mortality rates (MR) using negative binomial regression models. RESULTS: A total of 584,052 observations of Mexican adults were analyzed. The national expected NCDs MR per 100,000 inhabitants was 210.7 (95%CI: 196.1-226.7) in 2005 and increased to 322.4 (95%CI: 300.3-346.4) by 2021. Predictors of NCDs mortality (quintile 5 vs. quintile 1) included; indigeneity (IRR = 1.15, 95%CI: 1.12-1.19), poverty (IRR = 1.14, 95%CI: 1.13-1.15), affiliation with Mexican Social Security Institute (IRR = 1.11, 95%CI: 1.09-1.14), households with television (IRR = 1.14, 95%CI: 1.11-1.17), and high density of ultra-processed food, alcohol & tobacco retail stores (IRR = 1.15, 95%CI: 1.13-1.17). The greatest increases in MR were observed in municipalities from Oaxaca (>200% increments). CONCLUSION: There was an overall increase in NCDs MR from 2005 to 2021, with a significant geographic variation among Mexican municipalities. The results of this study highlight the importance of identifying priority areas in the country that urgently require public policies focused on local factors associated with deaths from NCDs, such as the regulation of the ultra-processed food, alcohol & tobacco retail stores, and efforts to reduce social inequalities.

Ultra-processed foods consumption and health-related outcomes: a systematic review of randomized controlled trials.

Introduction: The increase in ultra-processed foods (UPFs) intake has raised concerns about its impact on public health. Prospective observational studies have reported significant associations between higher intake of UPFs and adverse health outcomes. The aim of this study is to determine whether these associations could be confirmed in randomized controlled trials (RCTs). Methods: We conducted a systematic review to analyze the evidence on the effects of UPFs intake on health. A systematic search was conducted in Medline, Embase, Web of Science, Scopus, LILACS, and CENTRAL up to April 22, 2024. RCTs in English, Spanish, and Portuguese evaluating the health effects of interventions to modify UPFs intake were included. The certainty of evidence was determined using the GRADE methodology. Results: Three educational intervention studies and one controlled feeding trial were included, evaluating the effect of reducing the consumption of UPFs (455 participants, median follow-up, 12 weeks). No significant effects were observed in 30 out of the 42 outcomes evaluated. The controlled feeding trial in adults with stable weight showed a reduction in energy intake, carbohydrates, and fat (low certainty of evidence), as well as in body weight, total cholesterol, and HDL cholesterol (moderate certainty of evidence). In the educational intervention studies, a reduction in body weight and waist circumference was observed (low certainty of evidence) in women with obesity, as well as improvement in some dimensions of quality of life (very low certainty of evidence). No significant changes were observed in children and adolescents with obesity, while in overweight pregnant women, the consumption of UPFs was not reduced, so the observed benefits could be attributed to other components of the intervention. Conclusion: Interventions aimed at reducing the consumption of UPFs showed benefits on some anthropometric and dietary intake outcomes, although significant effects were not observed for most of the evaluated outcomes. The limited number and significant methodological limitations of the studies prevent definitive conclusions. Further well-designed and conducted RCTs are needed to understand the effects of UPF consumption on health.Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023469984.

Effect of reducing saturated fat intake on cardiovascular disease in adults: an umbrella review.

Introduction: Our objective was to explore the effect of the reduction of saturated fat (SAF) intake on cardiovascular disease, mortality and other health-related outcomes in adults. Methods: We conducted an umbrella review, searching Medline, Scopus, EMBASE, Cochrane Library, and LILACS databases for systematic reviews from December 1, 2012, to December 1, 2022. We have included meta-analyses of randomized controlled trials (RCTs) and cohort studies. We extracted effect sizes (95%CI), heterogeneity (I 2), and evidence quality rating based on the population, intervention, comparator, and outcomes. Results: 21 meta-analyses were included (three were from RCTs, and 18 were from cohort studies). Among meta-analyses of RCTs, 15 of the 45 associations were significant. The effect of reduction in SAF intake on combined cardiovascular events (RR 0.79, 95%CI 0.66-0.93) was graded as having moderate certainty of evidence. We found no effect on all-cause mortality, cardiovascular mortality, cancer deaths, and other cardiovascular events. Among meta-analyses of cohort studies, five of the 19 associations were significant. There was an increase in coronary heart disease mortality (HR 1.10, 95% CI 1.01-1.21) and breast cancer mortality (HR 1.51, 95% CI 1.09-2.09) in participants with higher SFA intake compared to reduced SFA. We found no effect on all-cause mortality, cardiovascular mortality, and other cardiovascular events. Conclusion: This umbrella review found the reduction in SAF intake probably reduces cardiovascular events and other health outcomes. However, it has little or no effect on cardiovascular mortality and mortality from other causes. More high-quality clinical trials with long-term follow-up are needed.Systematic review registration: CRD42022380859.

Interactions between genetic and lifestyle factors on cardiometabolic disease-related outcomes in Latin American and Caribbean populations: A systematic review.

Introduction: The prevalence of cardiometabolic diseases has increased in Latin American and the Caribbean populations (LACP). To identify gene-lifestyle interactions that modify the risk of cardiometabolic diseases in LACP, a systematic search using 11 search engines was conducted up to May 2022. Methods: Eligible studies were observational and interventional studies in either English, Spanish, or Portuguese. A total of 26,171 publications were screened for title and abstract; of these, 101 potential studies were evaluated for eligibility, and 74 articles were included in this study following full-text screening and risk of bias assessment. The Appraisal tool for Cross-Sectional Studies (AXIS) and the Risk Of Bias In Non-Randomized Studies-of Interventions (ROBINS-I) assessment tool were used to assess the methodological quality and risk of bias of the included studies. Results: We identified 122 significant interactions between genetic and lifestyle factors on cardiometabolic traits and the vast majority of studies come from Brazil (29), Mexico (15) and Costa Rica (12) with FTO, APOE, and TCF7L2 being the most studied genes. The results of the gene-lifestyle interactions suggest effects which are population-, gender-, and ethnic-specific. Most of the gene-lifestyle interactions were conducted once, necessitating replication to reinforce these results. Discussion: The findings of this review indicate that 27 out of 33 LACP have not conducted gene-lifestyle interaction studies and only five studies have been undertaken in low-socioeconomic settings. Most of the studies were cross-sectional, indicating a need for longitudinal/prospective studies. Future gene-lifestyle interaction studies will need to replicate primary research of already studied genetic variants to enable comparison, and to explore the interactions between genetic and other lifestyle factors such as those conditioned by socioeconomic factors and the built environment. The protocol has been registered on PROSPERO, number CRD42022308488. Systematic review registration: https://clinicaltrials.gov, identifier CRD420223 08488.

Racial/ethnic disparities in the cause of death among patients with prostate cancer in the United States from 1995 to 2019: a population-based retrospective cohort study.

Background: Racial/ethnic disparities in prostate cancer are reported in the United States (US). However, long-term trends and contributors of racial/ethnic disparities in all-cause and cause-specific death among patients with prostate cancer remain unclear. We analysed the trends and contributors of racial/ethnic disparities in prostate cancer survivors according to the cause of death in the US over 25 years. Methods: In this retrospective, population-based longitudinal cohort study, we identified patients diagnosed with first primary prostate cancer between 1995 and 2019, with follow-up until Dec 31, 2019, using population-based cancer registries' data from the Surveillance, Epidemiology, and End Results (SEER) Program. We calculated the cumulative incidence of death for each racial/ethnic group (Black, white, Hispanic, Asian or Pacific Islander [API], and American Indian or Alaska Native [AI/AN] people), by diagnostic period and cause of death. We quantified absolute disparities using rate changes for the 5-year cumulative incidence of death between racial/ethnic groups and diagnostic periods. We estimated relative (Hazard ratios [HR]) racial/ethnic disparities and the percentage of potential factors contributed to racial/ethnic disparities using Cox regression models. Findings: Despite a decreasing trend in the cumulative risk of death across five racial/ethnic groups, AI/AN and Black patients consistently had the highest rate of death between 1995 and 2019 with an adjusted HR of 1.48 (1.40-1.58) and 1.40 (1.38-1.42) respectively. The disparities in all-cause mortality between AI/AN and white patients increased over time, with adjusted HR 1.32 (1.17-1.49) in 1995-1999 and 1.95 (1.53-2.49) in 2015-2019. Adjustment of stage at diagnosis, initial treatment, tumor grade, and household income explained 33% and 24% of the AI/AN-white and Black-white disparities in all-cause death among patients with prostate cancer. Interpretation: The enduring racial/ethnic disparities in patients with prostate cancer, call for new interventions to eliminate health disparities. Our study provides important evidence and ways to address racial/ethnic inequality. Funding: National Key R&D Program of China, National Natural Science Foundation of China, Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support, the Open Research Fund from Beijing Advanced Innovation Center for Big Data-Based Precision Medicine, Key Projects of Philosophy and Social Sciences Research, Ministry of Education of China.

Sustainability of Diets in Mexico: Diet Quality, Environmental Footprint, Diet Cost, and Sociodemographic Factors.

Background: Little is known about the current intake of sustainable diets globally and specifically in middle-income countries, considering nutritional, environmental and economic factors. Objective: To assess and characterize the sustainability of Mexican diets and their association with sociodemographic factors. Design: Dietary data of 2,438 adults within the National Health and Nutrition Survey 2012 by integrating diet quality measured by the Healthy Eating Index (HEI-2015), diet cost, and four environmental indicators were analyzed: land use (LU), biodiversity loss (BDL), carbon footprint (CFP), and blue water footprint (BWFP). We defined healthier more sustainable diets (MSD) as those with HEI-2015 above the overall median, and diet cost and environmental indicators below the median. Logistic regression was used to evaluate the association of sociodemographic factors with MSD. Results: MSD were consumed by 10.2% of adults (4% of urban and 22% of rural), who had lower intake of animal-source foods, unhealthy foods (refined grains, added sugar and fats, mixed processed dishes and sweetened beverages), fruits, and vegetables, and higher intake of whole grains than non-MSD subjects. Characteristics of MSD vs. non-MSD (urban; rural) were: HEI-2015 (62.6 vs. 51.9; 66.8 vs. 57.6), diet-cost (1.9 vs. 2.8; 1.9 vs. 2.5 USD), LU (3.3 vs. 6.6; 3.2 vs. 5.9 m2), BDL (105 vs. 780; 87 vs. 586 species × 10-10), BWFP (244 vs. 403; 244 vs. 391 L), and CFP (1.6 vs. 4.4; 1.6 vs. 3.7 kg CO2eq). Adults from rural vs. urban (OR 2.7; 95% CI: 1.7, 4.1), or from the South (OR 2.1; 95% CI: 1.1, 3.9), Center (OR 2.3; 95% CI: 1.3, 4.4) vs. the North were more likely to consume MSD, while adults with high vs. low socioeconomic status were less likely (OR 0.17; 95% CI: 0.09, 0.3). Conclusions: The MSD is a realistic diet pattern mainly found in disadvantaged populations, but diet quality is still sub-optimal. Increased consumption of legumes, fruits, and vegetables, and a reduction in unhealthy foods, is required to improve nutritional quality of diets while ensuring their environmental sustainability.

Development of an online food frequency questionnaire and estimation of misreporting of energy intake during the COVID-19 pandemic among young adults in Peru.

Background: The Young Lives longitudinal study switched to remote data collection methods including the adaptation of dietary intake assessment to online modes due to the physical contact restrictions imposed by the COVID-19 pandemic. This study aimed to describe the adaptation process and validation of an online quantitative food frequency questionnaire (FFQ) for Peruvian young adults. Methods: A previously validated face-to-face FFQ for the adult Peruvian population was adapted to be administered through an online self-administered questionnaire using a multi-stage process. Questionnaire development was informed by experts' opinions and pilot surveys. FFQ validity was assessed by estimating misreporting of energy intake (EI) using the McCrory method, and the FFQ reliability with Cronbach alpha. Logistic regressions were used to examine associations of misreporting with sociodemographic, body mass index (BMI), and physical activity covariates. Results: The FFQ was completed by 426 Peruvian young adults from urban and rural areas, among whom 31% were classified as misreporters, with most of them (16.2%) overreporting daily EI. Men had a lower risk of under-reporting and a higher risk of over-reporting (OR = 0.28 and 1.89). Participants without a higher education degree had a lower risk of under-reporting and a higher risk of over-reporting (OR = 2.18 and 0.36, respectively). No major difference in misreporting was found across age groups, areas, studying as the main activity, being physically active or sedentary, or BMI. Results showed good internal reliability for the overall FFQ (Cronbach alpha = 0.82). Conclusion: Misreporting of EI was mostly explained by education level and sex across participants. Other sociodemographic characteristics, physical activity, sedentary behavior, and BMI did not explain the differences in EI misreporting. The adapted online FFQ proved to be reliable and valid for assessing dietary intakes among Peruvian young adults during the COVID pandemic. Further studies should aim at using and validating innovative dietary intake data collection methods, such as those described, for informing public health policies targeting malnutrition in different contexts after the COVID-19 pandemic.

Role of Government Financial Support and Vulnerability Characteristics Associated with Food Insecurity during the COVID-19 Pandemic among Young Peruvians.

Peruvian households have experienced one of the most prevalent economic shocks due to COVID-19, significantly increasing their vulnerability to food insecurity (FI). To understand the vulnerability characteristics of these households among the Peruvian young population, including the role of the government's response through emergency cash transfer, we analysed longitudinal data from the Young Lives study (n = 2026), a study that follows the livelihoods of two birth cohorts currently aged 18 to 27 years old. FI was assessed using the Food Insecurity Experience Scale. Household characteristics were collected before and during the COVID-19 outbreak in Peru to characterise participants' vulnerability to FI. Multivariate logistic regression was used to evaluate the association between government support and participants' vulnerability characteristics to FI. During the period under study (March to December 2020), 24% (95% CI: 22.1-25.9%) of the participants experienced FI. Families in the top wealth tercile were 49% less likely to experience FI. Larger families (>5 members) and those with increased household expenses and decreased income due to COVID-19 were more likely to experience FI (by 35%, 39% and 42%, respectively). There was no significant association between government support and FI (p = 0.768). We conclude that pre-pandemic socioeconomic status, family size, and the economic disruption during COVID-19 contribute to the risk of FI among the Peruvian young population, while government support insufficiently curtailed the risk to these households.

Ingesta de alimentos ultraprocesados y circunferencia de cintura según área de residencia en adultos peruanos / Ultra-processed food consumption and waist circumference by residence setting in Peruvian adults

Introducción. La circunferencia de cintura (CC) es indicador de obesidad abdominal y riesgo cardiovascular en adultos. En Perú, la obesidad ha aumentado a diferente magnitud por área de residencia y poco se sabe de la influencia del consumo de alimentos ultraprocesados (AUP) sobre este fenómeno en población adulta. Objetivo. Evaluar la asociación entre ingesta de AUP y circunferencia de cintura en adultos peruanos por área de residencia. Materiales y métodos. Estudio transversal de datos secundarios de 745 adultos con información de ingesta dietaria (un recordatorio de 24 horas) de la Encuesta Nacional Vigilancia Alimentaria y Nutricional por Etapas de Vida 2017-2018. Los AUP fueron caracterizados según la clasificación NOVA. La ingesta AUP como el porcentaje relativo de la ingesta energética total (%), dividida en terciles. La CC medida como punto medio entre última costilla y cresta iliaca. Se usó regresión lineal múltiple ponderada y análisis estratificado según área de residencia. Resultados. La edad promedio fue 37,2 años. La ingesta de AUP promedio fue 14,7% (IC95%: 14,2 ­ 15,3). Comparado con adultos en el menor tercil de ingesta de AUP, aquellos en tercil medio tuvieron mayor CC ( 0,73; IC95%: 0,22 ­ 1,24; valor p= 0,007). Al estratificar por área de residencia, adultos rurales del tercil medio tuvieron mayor CC en comparación con primer tercil ( : 1,85; IC95%: 1,17 ­ 2,53, valor p < 0,001). Conclusiones. En adultos peruanos, la ingesta de AUP se asoció a CC en áreas rurales, aunque no de forma lineal. Más estudios son necesarios para entender la naturaleza de esta asociación(AU)

Introduction. Waist circumference (WC) is an abdominal obesity and cardiovascular risk indicator among adults. In Peru, obesity prevalence has been increasing unequally between residence areas, and the influence of ultra- processed food (UPF) consumption on WC in Peruvian adults remains unclear. Objective. Evaluate the association between UPF consumption and waist circumference by residence setting among Peruvian adults. Materials and methods. A cross-sectional secondary analysis of dietary intake data (single 24-hour recall) from 745 adults aged 18 and 59 years old from the "Vigilancia Alimentaria y Nutricional por Etapas de Vida 2017-2018" National Surveys was performed. The NOVA system was used to characterize the UPFs, and the exposure was the percentage of total energy consumed from UPF per day (%), in quantiles. WC (cm) was assessed at the middle point between the last rib and the iliac crest. Weighted linear regression analysis stratified by residence areas were conducted. Results. The mean age was 37.2 years. The mean percent of total energy consumed from UPF was 14.7% (95%CI: 14.2 ­ 15.3). Those in the middle tertile of UPF consumption, had higher WC ( 0.73; 95%CI: 0.22 ­ 1.24; p-value = 0.007) compared with those in the lower tertile. In the stratified analysis, those in the second tertile in rural areas have more WC compared with the first tertile ( 1.85; 95%CI: 1.17 ­ 2.53, p-value< 0.001). Conclusions. In rural areas, UPF consumption was associated with waist circumference, but it does not follow a linear association. Further studies are needed to understand the rationale behind these results(AU)

Exploring the Barriers to and Facilitators of Using Evidence-Based Drugs in the Secondary Prevention of Cardiovascular Diseases: Findings From a Multistakeholder, Qualitative Analysis.

BACKGROUND: Health-system barriers and facilitators associated with cardiovascular medication adherence have seldom been studied, particularly in low- and middle-income countries where uptake rates are poorest. OBJECTIVES: This study sought to explore the major obstacles and facilitators to the use of evidence-supported medications for secondary prevention of cardiovascular disease using qualitative analysis in 2 diverse countries across multiple levels of their health care systems. METHODS: A qualitative descriptive study approach was implemented in Hamilton, Ontario, Canada, and Delhi, India. A purposeful sample (n = 69) of 23 patients, 10 physicians, 2 nurse practitioners, 5 Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy physicians, 11 pharmacists, 3 nurses, 4 hospital administrators, 1 social worker, 3 nongovernmental organization workers, 2 pharmaceutical company representatives, and 5 policy makers participated in interviews in Hamilton, Ontario, Canada (n = 21), and Delhi, India (n = 48). All interviews were digitally recorded and transcribed followed by directed content analysis to summarize and categorize the interviews. RESULTS: Themes that emerged across the stakeholder groups included: medication counseling; monitoring adherence; medication availability; medication affordability and drug coverage; time restrictions; and task shifting. The depth of verbal medication counseling provided varied substantially between countries, with prescribers in India unable to convey relevant information about drug treatments due to time constraint and high patient load. Canadian patients reported drug affordability as a common issue and very few patients were familiar with government subsidized drug programs. In India, patients purchased medications out-of-pocket from private, community pharmacies to avoid long commutes, lost wages, and unavailability of medications from hospitals formularies. Task shifting medication-refilling and titration to nonphysician health workers was accepted and supported by physicians in Canada but not in India, where many of the physicians considered a high level of clinical expertise a precondition to carry out these tasks skillfully. CONCLUSIONS: Our findings reveal context-specific, health system factors that affect the patient's choice or ability to initiate and/or continue cardiovascular medication. Strategies to optimize cardiovascular drug use should be targeted and relevant to the health care system.

Health system barriers and facilitators to medication adherence for the secondary prevention of cardiovascular disease: a systematic review.

BACKGROUND: Secondary prevention is cost-effective for cardiovascular disease (CVD), but uptake is suboptimal. Understanding barriers and facilitators to adherence to secondary prevention for CVD at multiple health system levels may inform policy. OBJECTIVES: To conduct a systematic review of barriers and facilitators to adherence/persistence to secondary CVD prevention medications at health system level. METHODS: Included studies reported effects of health system level factors on adherence/persistence to secondary prevention medications for CVD (coronary artery or cerebrovascular disease). Studies considered at least one of ß blockers, statins, angiotensin-renin system blockers and aspirin. Relevant databases were searched from 1 January 1966 until 1 October 2015. Full texts were screened for inclusion by 2 independent reviewers. RESULTS: Of 2246 screened articles, 25 studies were included (12 trials, 11 cohort studies, 1 cross-sectional study and 1 case-control study) with 132 140 individuals overall (smallest n=30, largest n=63 301). 3 studies included upper middle-income countries, 1 included a low middle-income country and 21 (84%) included high-income countries (9 in the USA). Studies concerned established CVD (n=4), cerebrovascular disease (n=7) and coronary heart disease (n=14). Three studies considered persistence and adherence. Quantity and quality of evidence was limited for adherence, persistence and across drug classes. Studies were concerned with governance and delivery (n=19, including 4 trials of fixed-dose combination therapy, FDC), intellectual resources (n=1), human resources (n=1) and health system financing (n=4). Full prescription coverage, reduced copayments, FDC and counselling were facilitators associated with higher adherence. CONCLUSIONS: High-quality evidence on health system barriers and facilitators to adherence to secondary prevention medications for CVD is lacking, especially for low-income settings. Full prescription coverage, reduced copayments, FDC and counselling may be effective in improving adherence and are priorities for further research.

Efficacy and safety of ezetimibe added to ongoing statin therapy for treatment of patients with primary hypercholesterolemia.

Ezetimibe is a lipid-lowering drug that inhibits the intestinal absorption of dietary and biliary cholesterol by blocking passage across the intestinal wall. The efficacy and safety of adding ezetimibe to ongoing statin therapy in patients with primary hypercholesterolemia was evaluated in a randomized, double-blind, placebo-controlled study. The study group included 769 adults (aged > or =18 years) with primary hypercholesterolemia who had not achieved National Cholesterol Education Program (NCEP) Adult Treatment Panel II goals with dietary alteration and statin monotherapy. Patients receiving a stable dose of a statin for > or =6 weeks were randomized to receive concurrent treatment with placebo (n = 390) or ezetimibe (n = 379), 10 mg/day, in addition to continuing their open-label statin for 8 weeks. The primary efficacy variable was the percent change in low-density lipoprotein (LDL) cholesterol from baseline with statin monotherapy to end point after intervention (secondary variables: high-density lipoprotein [HDL] cholesterol and triglycerides). Ongoing statin therapy plus ezetimibe led to changes of -25.1% for LDL cholesterol (HDL cholesterol +2.7%; triglycerides -14.0%) compared with LDL cholesterol -3.7% (p <0.001), HDL cholesterol +1.0% (p <0.05), and triglycerides -2.9% (p <0.001) for placebo added to ongoing statin therapy. Among patients not at LDL cholesterol goal at on-statin baseline, 71.5% receiving statin plus ezetimibe versus 18.9% receiving statin plus placebo reached goal at end point (odds ratio 23.7; p <0.001). The co-administration of statin and ezetimibe was generally well tolerated. Adding ezetimibe to ongoing statin therapy led to substantial additional reduction in LDL cholesterol levels, facilitating attainment of NCEP goals. Ezetimibe offers a new therapeutic option for patients receiving statins who require further reduction in LDL cholesterol.

A multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia.

OBJECTIVE: The purpose of this study was to evaluate the efficacy and safety profile of ezetimibe/simvastatin(EZE/SIMVA) combination tablet, relative to ezetimibe (EZE) and simvastatin (SIMVA) monotherapy, in patients with primary hypercholesterolemia. METHODS: This was a randomized, multicenter, double-blind, placebo-controlled, factorial design study After a 6- to 8-week washout period and 4-week, single-blind, placebo run in, hypercholesterolemic patients (low-density lipoprotein cholesterol [LDL-C], 145-250 mg/dL; triglycerides [TG], < or =350 mg/dL) were randomized equally to 1 of 10 daily treatments for 12 weeks: EZE/SIMVA 10/10, 10/20, 10/40, or 10/80 mg; SIMVA 10, 20, 40, or 80 mg; EZE 10 mg; or placebo. The primary efficacy analysis was mean percent change from baseline in LDL-C to study end point Secondary end points included percent changes in other lipid variables and C-reactive protein [CRP]. RESULTS: There were 1528 patients randomized to treatment (792 women, 736 men); mean (SD) age ranged from 54.9 (112) years to 56.4 (10.6) years across pooled treatment groups. The treatment groups were well balanced for baseline demographics. Pooled EZE/SIMVA was associated with greater reductions in LDL-C than pooled SIMVA or EZE alone (P < 0.001). Depending on dose, EZE/SIMVA was associated with reductions in LDL-C of -44.8% to -602%, non-high-density lipoprotein cholesterol of -40.5% to -55.7%, and TG of -22.5% to -30.7%; high-density lipoprotein cholesterol increased by 5.5% to 9.8%. EZE/SIMVA was associated with greater reductions in CRP and remnant-like particle-cholesterol than SIMVA alone (P < 0.001). More patients receiving EZE/SIMVA versus SIMVA achieved LDL-C concentrations <100 mg/dL (78.6% vs 45.9%; P < 0.001). EZE/SIMVA was generally well tolerated, with a safety profile similar to SIMVA monotherapy There were no significant differences between EZE/SIMVA and SIMVA in the incidence of consecutive liver transaminase levels > or =3 times the upper limit of normal (ULN) (1 .5% for EZE/SIMVA and 1.1% for SIMVA; P = NS) or creature kinase levels > or =10 times ULN (0.0% for EZE/SIMVA and 02% for SIMVA; P = NS). CONCLUSION: The EZE/SIMVA tablet was a highly effective and well-tolerated LDL-C-lowering therapy in this study of patients with primary hypercholesterolemia.