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Background The use of aspirin in the primary prevention of cardiovascular events remains controversial. We aimed to assess the efficacy and safety of aspirin versus placebo in patients with a moderate estimated risk of a first cardiovascular event. Methods ARRIVE is a randomised, double-blind, placebo-controlled, multicentre study done in seven countries. Eligible patients were aged 55 years (men) or 60 years (women) and older and had an average cardiovascular risk, deemed to be moderate on the basis of the number of specific risk factors. We excluded patients at high risk of gastrointestinal bleeding or other bleeding, or diabetes. Patients were randomly assigned (1:1) with a computer-generated randomisation code to receive enteric-coated aspirin tablets (100 mg) or placebo tablets, once daily. Patients, investigators, and others involved in treatment or data analysis were masked to treatment allocation. The primary efficacy endpoint was a composite outcome of time to first occurrence of cardiovascular death, myocardial infarction, unstable angina, stroke, or transient ischaemic attack. Safety endpoints were haemorrhagic events and incidence of other adverse events, and were analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00501059. Findings Between July 5, 2007, and Nov 15, 2016, 12 546 patients were enrolled and randomly assigned to receive aspirin (n=6270) or placebo (n=6276) at 501 study sites. Median follow-up was 60 months. In the intention-to-treat analysis, the primary endpoint occurred in 269 (4·29%) patients in the aspirin group versus 281 (4·48%) patients in the placebo group (hazard ratio [HR] 0·96; 95% CI 0·81–1·13; p=0·6038). Gastrointestinal bleeding events (mostly mild) occurred in 61 (0·97%) patients in the aspirin group versus 29 (0·46%) in the placebo group (HR 2·11; 95% CI 1·36–3·28; p=0·0007). The overall incidence rate of serious adverse events was similar in both treatment groups (n=1266 [20·19%] in the aspirin group vs n=1311 [20·89%] in the placebo group. The overall incidence of adverse events was similar in both treatment groups (n=5142 [82·01%] vs n=5129 [81·72%] in the placebo group). The overall incidence of treatment-related adverse events was low (n=1050 [16·75%] vs n=850 [13·54%] in the placebo group; p<0·0001). There were 321 documented deaths in the intention-to-treat population (n=160 [2·55%] vs n=161 [2·57%] of 6276 patients in the placebo group). Interpretation The event rate was much lower than expected, which is probably reflective of contemporary risk management strategies, making the study more representative of a low-risk population. The role of aspirin in primary prevention among patients at moderate risk could therefore not be addressed. Nonetheless, the findings with respect to aspirin's effects are consistent with those observed in the previously published low-risk primary prevention studies. [ABSTRACT FROM AUTHOR]

The 5-year risk of death after onset of heart failure (HF) is about 50%. Although previous studies have shown beneficial effects of light-to-moderate alcohol consumption and risk of cardiovascular diseases and mortality, it is unclear whether moderate alcohol consumption is associated with a lower risk of death in subjects with HF. We investigated whether alcohol consumption and type of alcohol preference are associated with the risk of total mortality in 449 US male physicians with prevalent HF. Alcohol consumption was assessed through food frequency questionnaire, and mortality was ascertained through annual follow-up questionnaires and adjudicated by an Endpoint Committee. The mean age of subjects was 75.7 ± 8.2 years with an average follow-up of 7 years. We found evidence of a J-shaped relation between alcohol consumption and mortality (hazard ratio [95% confidence interval] 1.00 [reference], 0.85 [0.61 to 1.20], 0.60 [0.40 to 0.88], and 0.71 [0.42 to 1.21] for alcohol intake of none, <1 drink/day, 1 to 2 drinks/day, and 3+ drinks/day, respectively [p for quadratic trend [ 0.058]). There was no relation between beverage preference (beer, wine, or liquor) and mortality. In conclusion, our data showed a J-shaped association between alcohol intake and mortality in patients with HF. [ABSTRACT FROM AUTHOR]

An introduction is presented in which the editor discusses various articles within the issue on topics including risk factors of cardiovascular disease, use of coronary artery calcium as risk markers and reclassification methods in risk prediction.

Background: Associations between anthropometry and head and neck cancer (HNC) risk are inconsistent. We aimed to evaluate these associations while minimizing biases found in previous studies. Methods: We pooled data from 1 941 300 participants, including 3760 cases, in 20 cohort studies and used multivariable-adjusted Cox proportional hazard regression models to estimate hazard ratios (HR) and 95% confidence intervals (CI) for the association of anthropometric measures with HNC risk overall and stratified by smoking status. Results: Greater waist circumference (per 5cm: HR=1.04, 95% CI 1.03-1.05, P-value for trend=<0.0001) and waist-to-hip ratio (per 0.1 unit: HR=1.07, 95% CI 1.05-1.09, P-value for trend=<0.0001), adjusted for body mass index (BMI), were associated with higher risk and did not vary by smoking status (P-value for heterogeneity=0.85 and 0.44, respectively). Associations with BMI (P-value for interaction=<0.0001) varied by smoking status. Larger BMI was associated with higher HNC risk in never smokers (per 5 kg/m2: HR=1.15, 95% CI 1.06-1.24, P-value for trend=0.0006), but not in former smokers (per 5 kg/m2: HR=0.99, 95% CI 0.93-1.06, P-value for trend=0.79) or current smokers (per 5 kg/m2: HR=0.76, 95% CI 0.71-0.82, P-value for trend=<0.0001). Larger hip circumference was not associated with a higher HNC risk. Greater height (per 5cm) was associated with higher risk of HNC in never and former smokers, but not in current smokers. Conclusions: Waist circumference and waist-to-hip ratio were associated positively with HNC risk regardless of smoking status, whereas a positive association with BMI was only found in never smokers. [ABSTRACT FROM AUTHOR]

Objectives To examine the specificity of dementia coding in large populations. Design Retrospective cohort and chart review study of dementia diagnosis. Setting U. S. Department of Veterans Affairs ( VA) New England healthcare system. Participants Veterans aged 50 and older given outpatient visit codes for dementia between January 1, 2000, and December 31, 2009. Measurements The frequency of the code 'dementia not otherwise specified ( DNOS)' as a first and final diagnosis was determined. DNOS use was examined according to provider type and geographic location. The medical records of 100 individuals with unspecified dementia were reviewed to determine their underlying diagnoses and describe their examination. Results Twenty-two thousand fifty veterans diagnosed with dementia were identified over 10 years of follow-up. One-third of all cases had no specific dementia code (n = 6,659). DNOS was the most commonly used code as a first dementia diagnosis (42.5%) and was second only to Alzheimer's type dementia (35.8%) as a final diagnosis. Individuals who saw geriatricians and neurologists were most likely to have a specific dementia diagnosis, and DNOS use was lowest in centers with the most dementia specialists. Only 12% of primary care physicians performed cognitive testing the first time they used the DNOS code, compared with 98% of specialists. Nearly half of individuals with a persistent diagnosis of DNOS met criteria for a specific dementia. Conclusion Substantial overuse was found of nonspecific dementia codes in the VA New England healthcare system, leading to an underestimation of the prevalence of Alzheimer's disease and other dementias. System-based changes in dementia coding and greater access to dementia specialists may help improve diagnostic specificity. [ABSTRACT FROM AUTHOR]

Lycopene is a major carotenoid with potent antioxidant properties that may provide protection against the development of type 2 diabetes mellitus (DM). In this study we examined the association between baseline dietary intakes of lycopene, lycopene-containing foods, and the subsequent development of type 2 DM in a large prospective cohort study. We analyzed a total of 35,783 women from the United States, aged > or =45 y and free from self-reported cardiovascular disease, cancer, and DM at baseline. Intakes of lycopene and total and individual tomato-based food products were assessed by a 131-item-validated semiquantitative food-frequency questionnaire. During a median follow-up of 10.2 y, 1544 cases of incident type 2 DM were documented. After adjusting for age, total energy intake, randomized treatment assignment, body mass index, and other known DM risk factors, the multivariate-adjusted relative risks and 95% CI of type 2 DM across increasing quintiles of dietary lycopene, were 1.00 (baseline), 1.10 (0.94-1.29), 1.10 (0.94-1.29), and 1.07 (0.91-1.26) (P linear trend = 0.56). Compared with women who consumed <1.5 servings/wk total tomato-based food products, women who consumed 1.5 to <4, 4 to <7, 7 to <10, and > or =10 servings/wk had multivariate relative risks (95% CI) of 1.03 (0.88-1.20), 1.02 (0.87-1.20), 1.09 (0.89-1.33), and 1.04 (0.80-1.36), respectively (P linear trend = 0.54). The associations for individual tomato-based food products were similar to the results for the combination of all tomato products. Our study found little evidence for an association between dietary intake of lycopene or lycopene-containing foods and the risk of type 2 DM. [ABSTRACT FROM AUTHOR]