Abstract Background Many patients report adverse reactions to, and may not tolerate, statin therapy. These patients may be at increased risk for coronary heart disease (CHD) events and mortality. ...Objectives This study evaluated the risk for recurrent myocardial infarction (MI), CHD events, and all-cause mortality in Medicare beneficiaries with statin intolerance and in those with high adherence to statin therapy. Methods We studied 105,329 Medicare beneficiaries who began a moderate- or high-intensity statin dosage after hospitalization for MI between 2007 and 2013. Statin intolerance was defined as down-titrating statins and initiating ezetimibe therapy, switching from statins to ezetimibe monotherapy, having International Classification of Diseases, 9th revision, diagnostic codes for rhabdomyolysis or an antihyperlipidemic adverse event, followed by statin down-titration or discontinuation, or switching between ≥3 types of statins within 1 year after initiation. High statin adherence over the year following hospital discharge was defined as proportion of days covered ≥80%. Recurrent MI, CHD events (recurrent MI or a coronary revascularization procedure), and mortality were identified from 1 year after hospital discharge through December 2014. Results Overall, 1,741 patients (1.65%) had statin intolerance, and 55,567 patients (52.8%) had high statin adherence. Over a median of 1.9 to 2.3 years of follow-up, there were 4,450 recurrent MIs, 6,250 CHD events, and 14,311 deaths. Compared to beneficiaries with high statin adherence, statin intolerance was associated with a 36% higher rate of recurrent MI (41.1 vs. 30.1 per 1,000 person-years, respectively), a 43% higher rate of CHD events (62.5 vs. 43.8 per 1,000 person-years, respectively), and a 15% lower rate of all-cause mortality (79.9 vs. 94.2 per 1,000 person-years, respectively). The multivariate-adjusted hazard ratios (HR) comparing beneficiaries with statin intolerance versus those with high statin adherence were 1.50 (95% confidence interval CI: 1.30 to 1.73) for recurrent MI, 1.51 (95% CI: 1.34 to 1.70) for CHD events, and 0.96 (95% CI: 0.87 to 1.06) for all-cause mortality. Conclusions Statin intolerance was associated with an increased risk for recurrent MI and CHD events but not all-cause mortality.
Abstract
Objective
With growing availability of digital health data and technology, health-related studies are increasingly augmented or implemented using real world data (RWD). Recent federal ...initiatives promote the use of RWD to make clinical assertions that influence regulatory decision-making. Our objective was to determine whether traditional real world evidence (RWE) techniques in cardiovascular medicine achieve accuracy sufficient for credible clinical assertions, also known as “regulatory-grade” RWE.
Design
Retrospective observational study using electronic health records (EHR), 2010–2016.
Methods
A predefined set of clinical concepts was extracted from EHR structured (EHR-S) and unstructured (EHR-U) data using traditional query techniques and artificial intelligence (AI) technologies, respectively. Performance was evaluated against manually annotated cohorts using standard metrics. Accuracy was compared to pre-defined criteria for regulatory-grade. Differences in accuracy were compared using Chi-square test.
Results
The dataset included 10 840 clinical notes. Individual concept occurrence ranged from 194 for coronary artery bypass graft to 4502 for diabetes mellitus. In EHR-S, average recall and precision were 51.7% and 98.3%, respectively and 95.5% and 95.3% in EHR-U, respectively. For each clinical concept, EHR-S accuracy was below regulatory-grade, while EHR-U met or exceeded criteria, with the exception of medications.
Conclusions
Identifying an appropriate RWE approach is dependent on cohorts studied and accuracy required. In this study, recall varied greatly between EHR-S and EHR-U. Overall, EHR-S did not meet regulatory grade criteria, while EHR-U did. These results suggest that recall should be routinely measured in EHR-based studes intended for regulatory use. Furthermore, advanced data and technologies may be required to achieve regulatory grade results.
Abstract Background Data prior to 2011 suggest that a low percentage of patients hospitalized for acute coronary syndromes filled high-intensity statin prescriptions upon discharge. Black-box ...warnings, generic availability of atorvastatin, and updated guidelines may have resulted in a change in high-intensity statin use. Objectives The aim of this study was to examine trends and predictors of high-intensity statin use following hospital discharge for myocardial infarction (MI) between 2011 and 2014. Methods Secular trends in high-intensity statin use following hospital discharge for MI were analyzed among patients 19 to 64 years of age with commercial health insurance in the MarketScan database (n = 42,893) and 66 to 75 years of age with U.S. government health insurance through Medicare (n = 75,096). Patients filling statin prescriptions within 30 days of discharge were included. High-intensity statins included atorvastatin 40 or 80 mg and rosuvastatin 20 or 40 mg. Results The percentage of beneficiaries whose first statin prescriptions filled following hospital discharge for MI were for high-intensity doses increased from 33.5% in January through March 2011 to 71.7% in October through November 2014 in MarketScan and from 24.8% to 57.5% in Medicare. Increases in high-intensity statin use following hospital discharge occurred over this period among patients initiating treatment (30.6% to 72.0% in MarketScan and 21.1% to 58.8% in Medicare) and those taking low- or moderate-intensity statins prior to hospitalization (from 27.8% to 62.3% in MarketScan and from 12.6% to 45.1% in Medicare). In 2014, factors associated with filling high-intensity statin prescriptions included male sex, filling beta-blocker and antiplatelet agent prescriptions, and attending cardiac rehabilitation within 30 days following discharge. Conclusions The use of high-intensity statins following hospitalization for MI increased progressively from 2011 through 2014.
Historically, women have been less likely than men to receive guideline-recommended statin therapy for the secondary prevention of myocardial infarction (MI).
The authors examined contemporary sex ...differences in prescription fills for high-intensity statin therapy following an MI, overall and across population subgroups, and assessed whether sex differences were attenuated following recent efforts to reduce sex disparities in the use of cardiovascular disease preventive therapies.
The authors studied 16,898 (26% women) U.S. adults <65 years of age with commercial health insurance in the MarketScan database, and 71,358 (49% women) U.S. adults ≥66 years of age with government health insurance through Medicare who filled statin prescriptions within 30 days after hospital discharge for MI in 2014 to 2015. The authors calculated adjusted women-to-men risk ratios and 95% confidence intervals (CIs) for filling a high-intensity statin prescription (i.e., atorvastatin 40 to 80 mg, and rosuvastatin 20 to 40 mg) following hospital discharge for MI.
In 2014 to 2015, 56% of men and 47% of women filled a high-intensity statin following hospital discharge for MI. Adjusted risk ratios for filling a high-intensity statin comparing women with men were 0.91 (95% CI: 0.90 to 0.92) in the total population, 0.91 (95% CI: 0.89 to 0.92) among those with no prior statin use, and 0.87 (95% CI: 0.85 to 0.90) and 0.98 (95% CI: 0.97 to 1.00) for those taking low/moderate-intensity and high-intensity statins prior to their MI, respectively. Women were less likely than men to fill high-intensity statins within all subgroups analyzed, and the disparity was largest in the youngest and oldest adults and for those without prevalent comorbid conditions.
Despite recent efforts to reduce sex differences in guideline-recommended therapy, women continue to be less likely than men to fill a prescription for high-intensity statins following hospitalization for MI.
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Objective:
There is recent interest in characterizing the subset of obese (OB) individuals who have healthy metabolic profiles yet only two studies have examined this group prospectively but not in ...racially diverse populations.
Design and Methods:
We analyzed factors associated with the prevalence and incidence of metabolic syndrome (MetSyn) among individuals grouped by BMI categories in a multi‐center, community‐based cohort of 14,663 African‐American and white men and women aged 45‐64 years at recruitment in 1987‐1989, the Atherosclerosis Risk in Communities (ARIC) Study. Logistic and proportional hazards regression were utilized to estimate odds ratios (ORs) for the prevalence and hazard ratios (HRs) for incidence of MetSyn with 95% confidence intervals (CIs).
Results:
At visit 1, MetSyn was positively associated with age, female gender, African‐American race, and inversely related to education, associations being more pronounced among normal weight (NW) subjects. Among those without MetSyn at visit 1, OB subjects were more likely to develop MetSyn compared with NW (HR (95% CI): 4.53 (4.09‐5.01)). Several factors were associated with incident MetSyn among NW, including older age (per year: 1.05 (1.03‐1.06)), female gender (vs. male: 1.29 (1.10‐1.52)), heavy alcohol intake (vs. never: 0.75 (0.59‐0.94)), and physical activity (tertile 3 vs. tertile 1: 0.71 (0.58‐0.86)) but not OB. Weight gain (>5%) was also more highly associated with MetSyn in NW (1.61 (1.28‐2.02)) compared with OB (1.01 (0.85‐1.20)).
Conclusions:
We conclude that lifestyle factors may play a stronger role in the development of MetSyn in NW individuals compared with OB and that metabolically healthy obesity may not be a stable condition.
There is recent interest in characterizing the subset of obese (OB) individuals who have healthy metabolic profiles yet only two studies have examined this group prospectively but not in racially ...diverse populations. We analyzed factors associated with the prevalence and incidence of metabolic syndrome (MetSyn) among individuals grouped by BMI categories in a multi-center, community-based cohort of 14,663 African-American and white men and women aged 45-64 years at recruitment in 1987-1989, the Atherosclerosis Risk in Communities (ARIC) Study. Logistic and proportional hazards regression were utilized to estimate odds ratios (ORs) for the prevalence and hazard ratios (HRs) for incidence of MetSyn with 95% confidence intervals (CIs). At visit 1, MetSyn was positively associated with age, female gender, African-American race, and inversely related to education, associations being more pronounced among normal weight (NW) subjects. Among those without MetSyn at visit 1, OB subjects were more likely to develop MetSyn compared with NW (HR (95% CI): 4.53 (4.09-5.01)). Several factors were associated with incident MetSyn among NW, including older age (per year: 1.05 (1.03-1.06)), female gender (vs. male: 1.29 (1.10-1.52)), heavy alcohol intake (vs. never: 0.75 (0.59-0.94)), and physical activity (tertile 3 vs. tertile 1: 0.71 (0.58-0.86)) but not OB. Weight gain (>5%) was also more highly associated with MetSyn in NW (1.61 (1.28-2.02)) compared with OB (1.01 (0.85-1.20)). We conclude that lifestyle factors may play a stronger role in the development of MetSyn in NW individuals compared with OB and that metabolically healthy obesity may not be a stable condition.
Background Prior studies suggest that persistence with and adherence to statin therapy is low. Interventions to improve statin persistence and adherence have been developed over the past decade. ...Methods and Results This was a retrospective cohort study of adults aged ≥21 y with commercial or government health insurance in the MarketScan (Truven Health Analytics) and Medicare databases who initiated statins in 2007-2014 and (1) started treatment after a myocardial infarction (n=201 573), (2) had diabetes mellitus but without coronary heart disease (CHD; n=610 049), or (3) did not have CHD or diabetes mellitus (n=2 244 868). Persistence with (ie, not discontinuing treatment) and high adherence to statin therapy were assessed using pharmacy fills in the year following treatment initiation. In 2007 and 2014, the proportions of patients persistent with statin therapy were 78.1% and 79.1%, respectively, among those initiating treatment following myocardial infarction; 66.5% and 67.3%, respectively, for those with diabetes mellitus but without CHD; and 64.3% and 63.9%, respectively, for those without CHD or diabetes mellitus. Between 2007 and 2014, high adherence to statin therapy increased from 57.9% to 63.8% among patients initiating treatment following myocardial infarction and from 34.9% to 37.6% among those with diabetes mellitus but without CHD (each P
<0.001). Among patients without CHD or diabetes mellitus, high adherence did not improve between 2007 (35.7%) and 2014 (36.8%; P
=0.14). In 2014, statin adherence was lower among younger, black, and Hispanic patients versus white patients and those initiating a high-intensity statin dosage. Statin adherence was higher among men and patients with cardiologist care following treatment initiation. Conclusions Persistence with and adherence to statin therapy remain low, particularly among those without CHD.
The FTO gene harbors the strongest known susceptibility locus for obesity. While many individual studies have suggested that physical activity (PA) may attenuate the effect of FTO on obesity risk, ...other studies have not been able to confirm this interaction. To confirm or refute unambiguously whether PA attenuates the association of FTO with obesity risk, we meta-analyzed data from 45 studies of adults (n = 218,166) and nine studies of children and adolescents (n = 19,268).
All studies identified to have data on the FTO rs9939609 variant (or any proxy r(2)>0.8) and PA were invited to participate, regardless of ethnicity or age of the participants. PA was standardized by categorizing it into a dichotomous variable (physically inactive versus active) in each study. Overall, 25% of adults and 13% of children were categorized as inactive. Interaction analyses were performed within each study by including the FTO×PA interaction term in an additive model, adjusting for age and sex. Subsequently, random effects meta-analysis was used to pool the interaction terms. In adults, the minor (A-) allele of rs9939609 increased the odds of obesity by 1.23-fold/allele (95% CI 1.20-1.26), but PA attenuated this effect (p(interaction) = 0.001). More specifically, the minor allele of rs9939609 increased the odds of obesity less in the physically active group (odds ratio = 1.22/allele, 95% CI 1.19-1.25) than in the inactive group (odds ratio = 1.30/allele, 95% CI 1.24-1.36). No such interaction was found in children and adolescents.
The association of the FTO risk allele with the odds of obesity is attenuated by 27% in physically active adults, highlighting the importance of PA in particular in those genetically predisposed to obesity.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
China has recently undergone rapid social and economic change. Increases in urbanization have led to equally rapid shifts toward more sedentary occupations through the acquisition of new technology ...and transitions away from a mostly agricultural economy. Our purpose was to utilize a detailed measure of urbanicity comprising 10 dimensions of urban services and infrastructure to examine its effects on the occupational physical activity patterns of Chinese adults. Longitudinal data were from individuals aged 18–55 from the years 1991–1997 of the China Health and Nutrition Survey (
N=4376 men and 4384 women). Logistic multilevel regression analyses indicated that men had 68% greater odds, and women had 51% greater odds, of light versus heavy occupational activity given the mean change in urbanization over the 6-year period. Further, simulations showed that light occupational activity increased linearly with increasing urbanization. After controlling for individual-level predictors, community-level urbanization explained 54% and 40% of the variance in occupational activity for men and women, respectively. This study provides empirical evidence of the reduction in intensity of occupational activity with modernization. It is likely that urbanization will continue unabated in China and this is liable to lead to further transitions in the labor market resulting in additional reductions in work-related activity. Because occupational activity remains the major source of energy expenditure for adults, unless alternative forms are widely adopted, the Chinese population is at risk of dramatic increases in the numbers of overweight and obese individuals.
Peripheral artery disease (PAD) is associated with increased risk for atherosclerotic cardiovascular disease (ASCVD) events.
The goal of this study was to compare the risk for ASCVD events and the ...use of statins among patients with PAD versus those with coronary heart disease (CHD) or cerebrovascular disease.
The authors conducted a retrospective cohort study of adults age ≥19 years with commercial or Medicare health insurance who had a history of PAD, CHD, or cerebrovascular disease on December 31, 2014. Patients were followed for ASCVD events comprising CHD, cerebrovascular disease, and PAD events until December 31, 2017.
Among 943,232 patients included in the analysis, the age-standardized ASCVD event rate per 1,000 person-years for those with a history of 1, 2, and 3 conditions including PAD, CHD, and cerebrovascular disease was 40.8 (95% confidence interval CI: 40.3 to 41.3), 68.9 (95% CI: 67.9 to 70.0), and 119.5 (95% CI: 117.0 to 122.0), respectively. The ASCVD event rate among patients with PAD only, CHD only, and cerebrovascular disease only was 34.7 (95% CI: 33.2 to 36.2), 42.2 (95% CI: 41.5 to 42.8), and 38.9 (95% CI: 37.6 to 40.1), respectively. Among patients with PAD and CHD, with PAD and cerebrovascular disease, and with CHD and cerebrovascular disease, the ASCVD event rate was 72.8 (95% CI: 71.0 to 74.7), 63.9 (95% CI: 60.6 to 67.4), and 67.9 (95% CI: 66.4 to 69.3), respectively. Statin use was lower in patients with PAD only (33.9%) versus those with cerebrovascular disease only (43.0%) or CHD only (51.7%).
Despite having high risk for ASCVD events, patients with PAD were less likely to be taking a statin versus those with CHD or cerebrovascular disease. ASCVD risk-reduction interventions including statin therapy in patients with PAD are warranted.
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