IMPORTANCE Despite extensive knowledge of hypertension treatment, the prevalence of uncontrolled hypertension is high and increasing in low-and middle-income countries.OBJECTIVE To test whether a community health worker-led multicomponent intervention would improve blood pressure (BP) control among low-income patients with hypertension.DESIGN, SETTING, AND PARTICIPANTS A cluster randomized trial was conducted in 18 centers for primary health care within a national public system providing free medications and health care to uninsured patients in Argentina. A total of 1432 low-income adult patients with uncontrolled hypertension were recruited between June 2013 and April 2015 and followed up to October 2016.INTERVENTIONS Nine centers (743 patients) were randomized to the multicomponent intervention, which included a community health worker-led home intervention (health coaching, home BP monitoring, and BP audit and feedback), a physician intervention, and a text-messaging intervention over 18 months. Nine centers (689 patients) were randomized to usual care. MAIN OUTCOMES AND MEASURESThe coprimary outcomes were the differences in systolic and diastolic BP changes from baseline to the end of follow-up of patients with hypertension. Secondary outcomes included the proportion of patients with controlled hypertension (BP <140/90 mm Hg). Three BP measurements were obtained at each of 2 baseline and 2 termination visits using a standard protocol, the means of which were used for analyses. RESULTSOf 1432 participants (mean age, 55.8 years [SD, 13.3]; 772 women [53.0%]), 1357 (94.8%) completed the trial. Baseline mean systolic BP was 151.7 mm Hg for the intervention group and 149.8 mm Hg for the usual care group; the mean diastolic BP was 92.2 mm Hg for the intervention group and 90.1 mm Hg for the usual care group. Systolic BP reduction from baseline to month 18 was 19.3 mm Hg (95% CI, 17.9-20.8 mm Hg) for the intervention group and 12.7 mm Hg (95% CI, 11.3-14.2 mm Hg) for the usual care group; the difference in the reduction was 6.6 mm Hg (95% CI, 4.6-8.6; P < .001). Diastolic BP decreased by 12.2 mm Hg (95% CI, 11.2-13.2 mm Hg) in the intervention group and 6.9 mm Hg (95% CI, 5.9-7.8 mm Hg) in the control group; the difference in the reduction was 5.4 mm Hg (95% CI, 4.0-6.8 mm Hg; P < .001). The proportion of patients with controlled hypertension increased from 17.0% at baseline to 72.9% at 18 months in the intervention group and from 17.6% to 52.2% in the usual care group; the difference in the increase was 20.6% (95% CI, 15.4%-25.9%; P < .001). No adverse events were reported.CONCLUSIONS AND RELEVANCE Low-income patients in Argentina with uncontrolled hypertension who participated in a community health worker-led multicomponent intervention experienced a greater decrease in systolic and diastolic BP than did patients who received usual care over 18 months. Further research is needed to assess generalizability and cost-effectiveness of this intervention and to understand which components may have contributed most to th...

Repositioning of the global epicentre of non-optimal cholesterol NCD Risk Factor Collaboration (NCD-RisC)* High blood cholesterol is typically considered a feature of wealthy western countries 1,2. However, dietary and behavioural determinants of blood cholesterol are changing rapidly throughout the world 3 and countries are using lipid-lowering medications at varying rates. These changes can have distinct effects on the levels of high-density lipoprotein (HDL) cholesterol and non-HDL cholesterol, which have different effects on human health 4,5. However, the trends of HDL and non-HDL cholesterol levels over time have not been previously reported in a global analysis. Here we pooled 1,127 population-based studies that measured blood lipids in 102.6 million individuals aged 18 years and older to estimate trends from 1980 to 2018 in mean total, non-HDL and HDL cholesterol levels for 200 countries. Globally, there was little change in total or non-HDL cholesterol from 1980 to 2018. This was a net effect of increases in low-and middle-income countries, especially in east and southeast Asia, and decreases in high-income western countries, especially those in northwestern Europe, and in central and eastern Europe. As a result, countries with the highest level of non-HDL cholesterol-which is a marker of cardiovascular riskchanged from those in western Europe such as Belgium,

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.

IntroductionHypercholesterolaemia is estimated to cause 2.6 million deaths annually and one-third of the cases of ischaemic heart disease. In Argentina, the prevalence of hypercholesterolaemia increased between 2005 and 2013 from 27.9% to 29.8%. Only one out of four subjects with a self-reported diagnosis of coronary heart disease is taking statins. Since 2014, statins (simvastatin 20 mg) are part of the package of drugs provided free-of-charge for patients according to cardiovascular disease (CVD) risk stratification. The goal of this study is to test whether a complex intervention targeting physicians and pharmacist assistants improves treatment and control of hypercholesterolaemia among patients with moderate-to-high cardiovascular risk in Argentina.Methods and analysisThis is a cluster trial of 350 patients from 10 public primary care centres in Argentina to be randomised to either the intervention or usual care. The study is designed to have 90% statistical power to detect a 0.7 mmol/L reduction in low-density lipoproteins cholesterol from baseline to 12 months. The physician education programme consists of a 2-day initial intensive training and certification workshop followed by educational outreach visits (EOVs) conducted at 3, 6 and 9 months from the outset of the study. An on-site training to pharmacist assistants during the first EOV is performed at each intervention clinic. In addition, two intervention support tools are used: an app installed in physician's smartphones to serve as a decision aid to improve prescription of statins according to patient's CVD risk and a web-based platform tailored to send individualised SMS messages to patients.Ethics and disseminationEthical approval was obtained from an independent ethics committee. Results of this study will be presented to the Ministry of Health of Argentina for potential dissemination and scale-up of the intervention programme to the entire national public primary care network in Argentina.Trial registration numberNCT02380911.

BackgroundHarmful effects of long-term exposure to moderately elevated low-density lipoprotein (LDL)-cholesterol and blood pressure on coronary heart disease (CHD) have not been rigorously examined. We estimated the risk of CHD under long-term exposure to moderately elevated LDL-cholesterol and blood pressure compared with the risk under shorter exposures to higher levels of the same risk factors.MethodsObservational study using data from 2,714 adults in Framingham Offspring Study who were free of existing cardiovascular disease and aged <70 years at baseline (1987–1991). We used the parametric g-formula to estimate 16-year CHD risk under different levels and durations of exposure to LDL-cholesterol (low: <130 mg/dL, moderate: 130 to <160 mg/dL, high 160 to <190 mg/dL, and very high: ≥190 mg/dL) and systolic blood pressure (low: <120 mmHg, prehypertension: 120 to <140 mmHg, stage 1 hypertension: 140 to <160 mmHg, and stage 2 hypertension: ≥160 mmHg).ResultsThe estimated 16-year CHD risk under exposure to low LDL was 8.2% (95% CI = 7.0–9.6). The 16-year CHD risk under exposure to moderate LDL was 8.9% (7.8–10.1) which was similar to CHD risk under 8 years of low LDL followed by 8 years of high LDL at 9.0% (7.7–10.3); and 12 years of low LDL followed by 4 years of very high LDL at 8.8% (7.6–10.1). The results for blood pressure were similar.ConclusionsLong-term exposure to moderate levels of LDL-cholesterol and blood pressure had a similar impact on CHD risk as shorter exposures to levels considered ‘high’ per clinical guidelines.

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Background: Hypertension is a major risk factor for cardiovascular disease (CVD). Despite advances in hypertension prevention and treatment, the proportion of patients who are aware, treated and controlled is low, particularly in lowincome and middle-income countries (LMICs). We will evaluate an adapted version of a multilevel and multicomponent hypertension control program in Guatemala, previously proven effective and feasible in Argentina. The program components are: protocol-based hypertension treatment using a standardized algorithm; team-based collaborative care; health provider education; health coaching sessions; home blood pressure monitoring; blood pressure audit; and feedback. Methods: Using a hybrid type 2 effectiveness-implementation design, we will evaluate clinical and implementation outcomes of the multicomponent program in Guatemala over an 18-month period. Through a cluster randomized trial, we will randomly assign 18 health districts to the intervention arm and 18 to enhanced usual care across five departments, enrolling 44 participants per health district and 1584 participants in total. The clinical outcomes are (1) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the intervention and control groups at 18 months and (2) the net change in systolic and diastolic blood pressure from baseline to 18 months. The context-enhanced Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM)/Practical Robust Implementation and Sustainability Model (PRISM) framework will guide the evaluation of the implementation at the level of the patient, provider, and health system. Using a mixed-methods approach, we will evaluate the following implementation outcomes:

The effects of interventions on multiple lifestyle and metabolic risk factors, initiated in midlife or later in a healthy population, on the long-term risk of first-ever stroke is not known. A particular methodological challenge in observational studies is to estimate the unbiased effect of a time-varying exposure in presence of time-varying confounders, if those confounders are affected by prior exposure. In such cases, the parametric g-formula can be applied to estimate an unbiased effect. We applied the parametric g-formula to estimate the 18-years (1994-2012) cumulative stroke risk under different scenarios of hypothetical interventions on levels of blood pressure, cholesterol, weight, physical activity, smoking and alcohol intake; and compared these to the observed scenario, to calculate the population risk ratios and risk differences. Among 14,796 eligible participants in the prospective, population-based Tromsø study (baseline mean age 46.1 years, 51% women), the observed 18-years stroke risk was 5.9%. A feasible joint hypothetical intervention on six lifestyle and metabolic risk factors would reduce the 18-year stroke risk by 32% (95% confidence interval 16, 44). A combination of more intensive interventions reduced the estimated 18-years stroke risk by 64% (95% confidence interval 40, 80). Blood pressure reduction and quitting smoking significantly reduced the risk when applied separately.