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BACKGROUND Adherence to study medications is crucial to evaluating treatment effects in clinical trials. To assess whether in the SPRINT trial, adherence and cardiovascular outcomes are associated regardless of intervention assignment. METHODS This study included 9,361 participants aged ≥50 years, recruited from 102 clinics. Participants were randomized to a Standard Treatment Group (targeted systolic blood pressure [SBP] <140 mm Hg) or an Intensive Treatment Group (targeted SBP <120 mm Hg) and followed for incident cardiovascular events until the study was halted early for benefit. The 8-item Morisky Medication Adherence Scale (MMAS-8) was administered at baseline, and at the 12- and 48-month (or close out) visit. RESULTS Adjusting for covariates, there was no association between the baseline 8-item MMAS-8 and the likelihood of the primary composite endpoint, any of the secondary endpoints, or blood pressure (BP) control. Low adherence was associated with a higher body mass index, SBP, diastolic BP, and Patient Health Questionnaire, and high adherence was associated with a higher Montreal Cognitive Assessment. There was no difference in the MMAS-8 over time by treatment arm assignment. For the primary outcome (a composite of myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes), baseline odds ratios (95% confidence intervals) for the Low vs. Medium and vs. High; and, for Medium vs. High MMAS-8 were 1.02 (0.82–1.28), 1.07 (0.85–1.34), and 1.05 (0.88–1.250). CONCLUSIONS In SPRINT, medication adherence as measured using the MMAS-8 was not associated with outcomes or BP control. [ABSTRACT FROM AUTHOR]

Objective: To examine the effects of an intensive lifestyle intervention (ILI) on cardiovascular disease (CVD), the Action for Health in Diabetes (Look AHEAD) trial randomized 5,145 participants with type 2 diabetes and overweight/obesity to a ILI or diabetes support and education. Although the primary outcome did not differ between the groups, there was suggestive evidence of heterogeneity for prespecified baseline CVD history subgroups (interaction P = 0.063). Event rates were higher in the ILI group among those with a CVD history (hazard ratio 1.13 [95% CI: 0.90-1.41]) and lower among those without CVD (hazard ratio 0.86 [95% CI: 0.72-1.02]).Methods: This study conducted post hoc analyses of the rates of the primary composite outcome and components, adjudicated cardiovascular death, nonfatal myocardial infarction (MI), stroke, and hospitalization for angina, as well as three secondary composite cardiovascular outcomes.Results: Interaction P values for the primary and two secondary composites were similar (0.060-0.064). Of components, the interaction was significant for nonfatal MI (P = 0.035). This interaction was not due to confounding by baseline variables, different intervention responses for weight loss and physical fitness, or hypoglycemic events. In those with a CVD history, statin use was high and similar by group. In those without a CVD history, low-density lipoprotein cholesterol levels were higher (P = 0.003) and statin use was lower (P ≤ 0.001) in the ILI group.Conclusions: Intervention response heterogeneity was significant for nonfatal MI. Response heterogeneity may need consideration in a CVD-outcome trial design. [ABSTRACT FROM AUTHOR]

BACKGROUND Left ventricular hypertrophy assessed by electrocardiography (ECG-LVH) is a marker of subclinical cardiac damage and a strong predictor of cardiovascular disease (CVD) events. The prevalence of ECG-LVH is increased in obesity and type 2 diabetes; however, there are no data on the long-term effects of weight loss on ECG-LVH. The purpose of this study was to determine whether an intensive lifestyle intervention (ILI) reduces ECG-LVH in overweight and obese adults with type 2 diabetes. METHODS Data from 4,790 Look AHEAD participants (mean age: 58.8 ± 6.8 years, 63.2% White) who were randomized to a 10-year ILI (n = 2,406) or diabetes support and education (DSE, n = 2,384) were included. ECG-LVH defined by Cornell voltage criteria was assessed every 2 years. Longitudinal logistic regression analysis with generalized estimation equations and linear mixed models were used to compare the prevalence of ECG-LVH and changes in absolute Cornell voltage over time between intervention groups, with tests of interactions by sex, race/ethnicity, and baseline CVD status. RESULTS The prevalence of ECG-LVH at baseline was 5.2% in the DSE group and 5.0% in the ILI group (P = 0.74). Over a median 9.5 years of follow-up, prevalent ECG-LVH increased similarly in both groups (odds ratio: 1.02, 95% confidence interval: 0.83–1.25; group × time interaction, P = 0.49). Increases in Cornell voltage during follow-up were also similar between intervention groups (group × time interaction, P = 0.57). Intervention effects were generally similar between subgroups of interest. CONCLUSIONS The Look AHEAD long-term lifestyle intervention does not significantly lower ECG-LVH in overweight and obese adults with type 2 diabetes. CLINICAL TRIALS REGISTRATION Trial Number NCT00017953 (ClinicalTrials.gov) [ABSTRACT FROM AUTHOR]

It is unclear whether metabolic syndrome (MetS) is associated with atrial fibrillation (AF) in an older population with greater cardiovascular risk, including those with chronic kidney disease. The authors investigated the association between MetS and AF in participants in SPRINT (Systolic Blood Pressure Intervention Trial). MetS was defined based on the Modified Third National Cholesterol Education Program. The baseline prevalence rate for MetS was 55%, while 8.2% of the participants had AF. In multivariate regression analyses, AF was not associated with presence of MetS in either chronic kidney disease or non-chronic kidney disease subgroups. Age, race, history of cardiovascular diseases, decreased triglycerides, decreased pulse pressure, and albuminuria remained significantly associated with AF risk. In contrast to the general population, MetS was not associated with AF in the older population with increased cardiovascular risk studied in SPRINT. [ABSTRACT FROM AUTHOR]

Background: The association between perceived stress and atrial fibrillation (AF) remains unclear.Purpose: The aim of this study was to examine the association between perceived stress and AF.Methods: A total of 25,530 participants (mean age 65 ± 9.4 years; 54 % women; 41 % blacks) from the REasons for Geographic And Racial Differences in Stroke (REGARDS) study were included in this analysis. Logistic regression was used to compute odds ratios (OR) and 95 % confidence intervals (CI) for the association between the short version of the Cohen Perceived Stress Scale and AF.Results: In a multivariable analysis adjusted for demographics, cardiovascular risk factors, and potential confounders, the prevalence of AF was found to increase with higher levels of stress (none: OR = 1.0, referent; low stress: OR = 1.12, 95 % CI = 0.98, 1.27; moderate stress OR = 1.27, 95 % CI = 1.11, 1.47; high stress: OR = 1.60, 95 % CI = 1.39, 1.84).Conclusion: Increasing levels of perceived stress are associated with prevalent AF in REGARDS. [ABSTRACT FROM AUTHOR]

BACKGROUND Pulse pressure (PP) is a potential risk factor of stroke. The relationship of incident stroke with systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and PP was examined. METHODS Data were from the REasons for Geographic And Racial Differences in Stroke national cohort study of 30,239 black and white participants aged ≥45 years, enrolled between 2003 and 2007. PP (SBP-DBP) and MAP (MAP = DBP + 1/3*PP) were calculated. Telephone followup occurred every six months for self or proxy-reported suspected stroke events, confirmed using expert adjudication. Cox-proportional hazards models examined the association of incident stroke for the different BP measurements with multivariable adjustment for sociodemographic and clinical risk factors including gender and race. RESULTS Men and women without prevalent stroke at baseline were analyzed (n = 25,462). During follow-up (mean 6.3 ± 2.3 years, maximum 10 years), 916 strokes occurred. Unadjusted PP (hazard ratio [HR] = 1.30; 95% confidence interval [CI] 1.24-1.35), SBP (HR = 1.22; 95% CI 1.18-1.32), MAP (HR = 1.24; 95% CI 1.16-1.32), and DBP (HR = 1.09; 95% CI 1.01-1.17) were associated with stroke risk; however, after adjustment for SBP and other risk factors, the association with PP was attenuated (HR = 0.98; 95% CI 0.90-1.07), whereas SBP persisted as a predictor (HR = 1.14; 95% CI 1.06-1.23). These associations were consistent across age (younger vs. older >70 years) and race (black vs. white). CONCLUSIONS PP is positively associated with incident stroke, but not independently from SBP; and, there were no significant gender, racial, or regional differences in that association. [ABSTRACT FROM AUTHOR]