LANDMARK TRIALS
Year : 2016 | Volume
: 5 | Issue : 3 | Page : 104--106
Recent trials in cardiology: Newer evidence in prevention of cardiovascular disease
Gagandeep Singh Wander
Department of Cardiology, Medanta - The Medicity, Gurgaon, Haryana, India
Correspondence Address:
Gagandeep Singh Wander
Department of Cardiology, Medanta - The Medicity, Sector 38, Gurgaon - 122 001, Haryana
India
How to cite this article:
Wander GS. Recent trials in cardiology: Newer evidence in prevention of cardiovascular disease.J Clin Prev Cardiol 2016;5:104-106
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How to cite this URL:
Wander GS. Recent trials in cardiology: Newer evidence in prevention of cardiovascular disease. J Clin Prev Cardiol [serial online] 2016 [cited 2023 Mar 29 ];5:104-106
Available from: https://www.jcpconline.org/text.asp?2016/5/3/104/191102 |
Full Text
Cardiovascular disease remains a leading cause of morbidity and mortality despite improvements in clinical outcomes. Prevention is the only effective strategy at the mass level as the elimination of health risk behaviors would make it possible to prevent as much as 80% of cardiovascular disease. Very recently, several studies have become available that have quantified the effect of various lifestyle-related aspects such as dietary fats, obesity, and attending religious service on the hard endpoint of total mortality. At the same time, a new study has evaluated the usefulness of mobile technology driven implementation of lifestyle changes in the short-term improvement of various health parameters. Finally, another study has assessed the impact of medication adherence on the long-term cardiovascular outcomes.
Association of Specific Dietary Fats with Total and Cause-specific Mortality
Wang DD, Li Y, Chiuve SE, Stampfer MJ, Manson JE, Rimm EB, et al. Association of specific dietary fats with total and cause-specific mortality. JAMA Intern Med 2016;176:1134-45.
Previous studies have shown distinct associations between specific dietary fat and cardiovascular disease. However, evidence on specific dietary fat and mortality is limited and not consistent. The study was done to examine the associations of specific dietary fats with total and cause-specific mortality in two large ongoing cohort studies.
This cohort study investigated 83,349 women from the Nurses' Health Study (July 1, 1980, to June 30, 2012) and 42,884 men from the Health Professionals Follow-up Study (February 1, 1986, to January 31, 2012) who were free of cardiovascular disease, cancer, and Types 1 and 2 diabetes at baseline. Dietary fat intake was assessed at baseline and updated periodically. Information on mortality was obtained from systematic searches of the vital records. Data were analyzed from September 2014 to March 2016. The main outcome was total and cause-specific mortality.
During 3,439,954 person-years of follow-up up to 32 years, 33,304 deaths were documented. The results were adjusted for known and suspected risk factors. Dietary total fat compared with total carbohydrates was inversely associated with total mortality (hazard ratio [HR] comparing extreme quintiles, 0.84; 95% confidence interval [CI], 0.81-0.88). The HRs of total mortality comparing extreme quintiles of specific dietary fats were 1.08 (95% CI, 1.03-1.14) for saturated fat, 0.81 (95% CI, 0.78-0.84) for polyunsaturated fatty acid (PUFA), 0.89 (95% CI, 0.84-0.94) for monounsaturated fatty acid (MUFA), and 1.13 (95% CI, 1.07-1.18) for trans-fat. Replacing 5% of energy from saturated fats with equivalent energy from PUFA and MUFA was associated with estimated reductions in total mortality of 27% (HR, 0.73; 95% CI, 0.70-0.77) and 13% (HR, 0.87; 95% CI, 0.82-0.93), respectively. The HR for total mortality comparing extreme quintiles of ω-6 PUFA intake was 0.85 (95% CI, 0.81-0.89; P < 0.001 for trend). Intake of ω-6 PUFA, especially linoleic acid, was inversely associated with mortality owing to most major causes, whereas marine ω-3 PUFA intake was associated with a modestly lower total mortality (HR comparing extreme quintiles, 0.96; 95% CI, 0.93-1.00; P = 0.002 for trend).
Perspective
The study found that higher intakes of PUFA and MUFA were associated with lower mortality, whereas higher intakes of saturated fatty acids and trans fatty acids were associated with increased mortality. These findings support current dietary recommendations to replace saturated fat and trans-fat with unsaturated fats.
Association of Religious Service Attendance with Mortality among Women
Li S, Stampfer MJ, Williams DR, Vander Weele TJ. Association of religious service attendance with mortality among women. JAMA Intern Med 2016;176:777-85.
Previous studies on the association between attendance at religious services and mortality had several limitations such as inadequate methods for reverse causation, inability to assess effects over time, and little information on mediators and cause-specific mortality. The present study was therefore done to evaluate associations between attendance at religious services and subsequent mortality in women.
Attendance at religious services was assessed from the first questionnaire in 1992 through June 2012 by a self-reported question asked of 74,534 women in the Nurses' Health Study who were free of cardiovascular disease and cancer at baseline. Data analysis was conducted from the return of the 1996 questionnaire through June 2012. Adjustments were made for a wide range of demographic covariates, lifestyle factors, and medical history measured repeatedly during the follow-up.
Among the 74,534 women participants, there were 13,537 deaths, including 2721 owing to cardiovascular disease and 4479 owing to cancers. After multivariable adjustment for major lifestyle factors, risk factors, and attendance at religious services in 1992, attending a religious service more than once per week was associated with 33% lower all-cause mortality compared with women who had never attended religious services (HR, 0.67; 95% CI, 0.62-0.71; P < 0.001 for trend). As compared to women who attended religious services more than once per week with those who never attend, the HR for cardiovascular mortality was 0.73 (95% CI, 0.62-0.85; P < 0.001 for trend) and for cancer mortality was 0.79 (95% CI, 0.70-0.89; P < 0.001 for trend). Results were robust in sensitivity analysis. Depressive symptoms, smoking, social support, and optimism were potentially important mediators although the overall proportion of the association between attendance at religious services and mortality was moderate (e.g. social support explained 23% of the effect [P = 0.003], depressive symptoms explained 11% [P < 0.001], smoking explained 22% [P < 0.001], and optimism explained 9% [P < 0.001]).
Perspective
Frequent attendance at religious services was associated with significantly lower risk of all-cause, cardiovascular, and cancer mortality among women. Religion and spirituality may be an underappreciated resource that physicians could explore with their patients as appropriate.
Body-mass Index and All-cause Mortality: Individual-participant Data Meta-analysis of 239 Prospective Studies in Four Continents
Global BMI Mortality Collaboration. Body-mass index and all-cause mortality: Individual-participant-data meta-analysis of 239 prospective studies in four continents. Lancet 2016;388:776-86.
As overweight and obesity are increasing worldwide, the study was conducted to help assess their relevance to mortality in different populations. Individual participant data meta-analyses of prospective studies of body mass index (BMI) were done. To limit confounding and reverse causality, the study was restricted to never-smokers and excluding preexisting disease and the first 5 years of follow-up.
Of the 10,625,411 participants in Asia, Australia and New Zealand, Europe, and North America from 239 prospective studies (median follow-up 13.7 years, interquartile range 11.4-14.7), 3,951,455 people in 189 studies were never-smokers, without chronic diseases at recruitment and who survived 5 years. Among these patients 385,879 died. The primary analyses were made of these deaths. Age- and sex-adjusted HRs relative to BMI 22.5-<25·0 kg/m² were studied.
All-cause mortality was minimal at BMI 20.0-25.0 kg/m² (HR 1.00, 95% CI 0.98-1.02 for BMI 20.0-<22.5 kg/m²; 1.00, 0.99-1.01 for BMI 22.5-<25.0 kg/m²). It increased significantly both just below this range (1.13, 1.09-1.17 for BMI 18.5-<20.0 kg/m²; 1.51, 1.43-1.59 for BMI 15.0-<18.5) and throughout the overweight range (1.07, 1.07-1.08 for BMI 25.0-<27.5 kg/m²; 1.20, 1.18-1.22 for BMI 27.5-<30.0 kg/m²). The HR for obesity Grade 1 (BMI 30.0-<35.0 kg/m²) was 1.45, 95% CI 1.41-1.48; the HR for obesity Grade 2 (35.0-<40.0 kg/m²) was 1.94, 1.87-2.01; and the HR for obesity Grade 3 (40.0-<60.0 kg/m²) was 2.76, 2.60-2.92. For BMI over 25.0 kg/m², mortality increased approximately log-linearly with BMI. The HR per 5 kg/m² units higher BMI was 1.39 in Europe, 1.29 in North America, 1.39 in East Asia, and 1.31 in Australia and New Zealand. This HR per 5 kg/m² units higher BMI (for BMI over 25 kg/m²) was greater in younger than older people (1.52 for BMI measured at 35-49 years vs. 1.21 for BMI measured at 70-89 years; P heterogeneity <0.0001) greater in men than women (1.51 vs. 1.30; P heterogeneity <0.0001).
Perspective
The associations of both overweight and obesity with higher all-cause mortality were broadly consistent in four continents. This finding supports strategies to combat the entire spectrum of excess adiposity in different populations.
International Mobile-health Intervention on Physical Activity, Sitting, and Weight: The Stepathlon Cardiovascular Health Study
Ganesan AN, Louise J, Horsfall M, Bilsborough SA, Hendriks J, McGavigan AD, et al. International mobile-health intervention on physical activity, sitting, and weight: The Stepathlon Cardiovascular Health Study. J Am Coll Cardiol 2016;67:2453-63.
Although proof-of-concept for mobile health (mHealth) lifestyle programs targeting physical inactivity and overweight/obesity has been established in randomized trials, the feasibility and effect of a globally distributed, large-scale, mass-participation mHealth implementation have not been investigated. The purpose of this study was to determine the effect of Stepathlon, an international, low-cost, mass-participation mHealth intervention, on physical activity, sitting, and weight.
The investigators prospectively collected cohort data from participants completing Stepathlon (an annual 100-day global event) in 2012, 2013, and 2014. Participants were organized in worksite-based teams, issued pedometers, and encouraged to increase daily steps and physical activity as a part of the team-based race. The program was conducted through an interactive multiplatform application available on mobile devices and the internet.
A total of 69,219 participants participated (481 employers, 1481 cities, 64 countries, all populated continents, age 36 ± 9 years, 23.9% female, 8.0% high-income countries, and 92.0% lower-middle income countries). After Stepathlon completion, participants recorded improved step count (+3519 steps/day; 95% CI: 3484-3553 steps/day; P < 0.0001), exercise days (+0.89 days; 95% CI: 0.87-0.92 days; P < 0.0001), sitting duration (−0.74 h; 95% CI: −0.78-−0.71 h; P < 0.0001), and weight (−1.45 kg; 95% CI: −1.53-−1.38 kg; P < 0.0001). Improvements occurred in women and men, in all geographic regions, and in both high and lower-middle income countries, and the results were reproduced in 2012, 2013, and 2014 cohorts. Predictors of weight loss included step increase, sitting duration decrease, and increase in exercise days (all P < 0.0001).
Perspective
The mHealth implementation of a low-cost lifestyle intervention is associated with short-term, reproducible, large-scale improvements in physical activity, sitting, and weight.
Assessing the impact of medication adherence on long-term cardiovascular outcomes
Bansilal S, Castellano JM, Garrido E, Wei HG, Freeman A, Spettell C, et al. Assessing the impact of medication adherence on long-term cardiovascular outcomes. J Am Coll Cardiol 2016;68:789-801.
It is known that guideline-recommended therapies reduce the major adverse cardiovascular events (MACE) in patients after myocardial infarction (MI) or those with atherosclerotic disease (ATH). However, the adherence to treatment is poor with <50% patients adherent at 2 years. The study was designed to determine the association between medication adherence levels and long-term MACE in these patients.
The investigators queried the claims database of a large health insurer for patients hospitalized for MI or with ATH. The primary outcome measure was a composite of all-cause death, MI, stroke, or coronary revascularization. Using a proportion of days covered for statins and angiotensin-converting enzyme inhibitors, patients were stratified as fully adherent (≥80%), partially adherent (≥40%-≤79%), or nonadherent (<40%). Per-patient annual direct medical (ADM) costs were estimated. The medication adherence assessment period was 6 months for the post-MI cohort and 12 months for the atherosclerosis cohort.
Data for 4015 post-MI patients and 12,976 patients with ATH were analyzed. At 2 years, in the post-MI cohort, the fully adherent group had a significantly lower rate of MACE than the nonadherent (18.9% vs. 26.3%; HR: 0.73; P = 0.0004) and partially adherent (18.9% vs. 24.7%; HR: 0.81; P ¼ 0.02) groups. The results revealed that by being fully adherent, the risk of MACE was reduced by >25% compared with nonadherence and by at least 20% compared with partial adherence. Moreover, to accrue benefit required a very high level of adherence (>80%) in the acute phase in post-MI patients. The fully adherent group had reduced per-patient ADM costs for MI hospitalizations of $369 and $440 compared with the partially adherent and nonadherent groups, respectively.
In the ATH cohort, the fully adherent group had a significantly lower rate of MACE than the nonadherent (8.42% vs. 17.17%; HR: 0.56; P < 0.0001) and the partially adherent (8.42% vs. 12.18%; HR: 0.76; P < 0.0001) groups at 2 years. However, the results suggested that partial adherence (>40% long-term adherence) in the more chronic atherosclerosis model was also associated with significantly reduced MACE rate than nonadherence. The fully adherent group had reduced per-patient ADM costs for MI hospitalizations of $371 and $907 compared with the partially adherent and nonadherent groups.
Perspective
Full adherence to guideline-recommended therapies is associated with a lower rate of MACE and cost savings, with a threshold effect at >80% adherence in the post-MI population. At least a 40% level of long-term adherence needs to be maintained to continue to accrue benefit. Novel approaches to improve adherence may significantly reduce cardiovascular events.
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