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The New England Journal of Medicine | 1991

Sex Differences in the Management of Coronary Artery Disease

Richard M. Steingart; Milton Packer; Peggy Hamm; Mary Ellen Coglianese; Bernard J. Gersh; Edward M. Geltman; Josephine Sollano; Stanley Katz; Lem Moyé; Lofty L. Basta; Sandra J. Lewis; Stephen S. Gottlieb; Victoria Bernstein; Patricia McEwan; Kirk Jacobson; Edward J. Brown; Marrick L. Kukin; Niki Kantrowitz; Marc A. Pfeffer

BACKGROUND Despite the fact that coronary artery disease is the leading cause of death among women, previous studies have suggested that physicians are less likely to pursue an aggressive approach to coronary artery disease in women than in men. To define this issue further, we compared the care previously received by men and women who were enrolled in a large postinfarction intervention trial. METHODS We assessed the nature and severity of anginal symptoms and the use of antianginal and antiischemic interventions before enrollment in the 1842 men and 389 women with left ventricular ejection fractions less than or equal to 40 percent after an acute myocardial infarction who were randomized in the Survival and Ventricular Enlargement trial. RESULTS Before their index infarction, women were as likely as men to have had angina and to have been treated with antianginal drugs. However, despite reports by women of symptoms consistent with greater functional disability from angina, fewer women had undergone cardiac catheterization (15.4 percent of women vs. 27.3 percent of men, P less than 0.001) or coronary bypass surgery (5.9 percent of women vs. 12.7 percent of men, P less than 0.001). When these differences were adjusted for important covariates, men were still twice as likely to undergo an invasive cardiac procedure as women, but bypass surgery was performed with equal frequency among the men and women who did undergo cardiac catheterization. CONCLUSIONS Physicians pursue a less aggressive management approach to coronary disease in women than in men, despite greater cardiac disability in women.


Annals of Internal Medicine | 1998

Effect of pravastatin on cardiovascular events in older patients with myocardial infarction and cholesterol levels in the average range. Results of the Cholesterol and Recurrent Events (CARE) trial.

Sandra J. Lewis; Lemuel A. Moyé; Frank M. Sacks; David E. Johnstone; Gerald C. Timmis; Jayne Mitchell; Marian C. Limacher; Sherron Kell; Stephen P. Glasser; Jane Grant; Barry R. Davis; Marc A. Pfeffer; Eugene Braunwald

Three fourths of deaths from myocardial infarction occur in patients older than 65 years of age, making cardiovascular disease the leading cause of death in older persons [1, 2]. Older patients, despite their high risk for cardiovascular death, are less likely to receive cardioprotective medications or interventions [3-15] or to be enrolled in clinical trials that test potentially beneficial treatments [3]. Although much information is available on serum cholesterol as a predictor of coronary artery disease in younger patients, as well as on the benefits of reduction of serum cholesterol levels, the role of cholesterol in coronary artery disease in older patients is less clear. Elevated cholesterol levels do not strongly predict coronary events in older patients [16-23]; thus, the need for cholesterol screening and treatment in older persons has generated much divergent opinion [22-31]. Recent analysis of a cohort of older persons (mean age, 80 years) strongly suggested that concomitant disease or debilitation was associated with low blood cholesterol levels and was responsible for the reduced ability of serum cholesterol levels to predict the incidence of coronary events. After adjustment for low serum iron and albumin levels and exclusion of events in the first year of follow-up, serum cholesterol levels became a significant predictor of coronary death [32]. Without this adjustment, no such association was seen [32]. Almost all trials of cholesterol treatment have excluded patients who were 65 years of age or older. The National Cholesterol Education Panel guidelines [33] therefore extrapolated findings from the treatment of younger patients in their recommendations for treating older patients, noting the considerable potential for absolute risk reduction given the high incidence of cardiovascular events in older patients. More recently, researchers observed that simvastatin treatment of hypercholesterolemic patients with coronary artery disease reduced recurrent major coronary events in the subset of patients who were 65 to 70 years of age at study entry [34]. However, information is needed on the effect of lipid treatment in older patients who have had myocardial infarction and have average cholesterol levels; most patients who have had myocardial infarction have cholesterol values in the average, not elevated, range [35-37]. The Cholesterol and Recurrent Events (CARE) trial [38] investigated whether reducing average cholesterol levels by using pravastatin in patients who have had myocardial infarction would prevent recurrent cardiac events. It showed that in patients with average cholesterol levels, pravastatin therapy reduced the risk for coronary death or recurrent myocardial infarction by 24% (P = 0.003), reduced the risk for fatal and nonfatal myocardial infarction by 25% (P = 0.006), reduced the risk for coronary artery bypass grafting and angioplasty by 27% (P < 0.001), and reduced the risk for stroke by 31% (P = 0.03) [38]. It also reported that patients who were older than the median age of 59 years had a reduced rate of coronary death, nonfatal myocardial infarction, coronary artery bypass grafting, or percutaneous transluminal coronary angioplasty. Of the 4159 patients in the CARE trial, 1283 (31%) were 65 to 75 years of age at baseline; these patients are eligible for retirement health care (Medicare) benefits in the United States. We report on the effect of pravastatin on individual cardiovascular events in these older patients, including myocardial infarction, coronary artery bypass grafting, angioplasty, and stroke, as well as on overall hospitalization for cardiovascular disease. Methods Study Design and Patients The design and results of the CARE trial have been described in detail elsewhere [38, 39]. The study was a randomized, double-blind, placebo-controlled trial with a planned average follow-up of 5 years. Patients were recruited from 80 participating centers in the United States and Canada. Institutional review board approval was obtained for investigation of human participants. Patients were eligible if they had had an acute myocardial infarction 3 to 20 months before randomization; were 21 to 75 years of age; and had plasma total cholesterol levels less than 6.2 mmol/L (240 mg/dL), low-density lipoprotein (LDL) cholesterol levels of 3.0 to 4.5 mmol/L (115 to 174 mg/dL), and fasting triglyceride levels less than 4.0 mmol/L (350 mg/dL). The diagnosis of myocardial infarction was confirmed by the MI Confirmation Core Laboratory, which evaluated reports of changes in serum creatine kinase levels, electrocardiographic evidence, and clinical symptoms [38, 39]. Plasma lipids were measured at least 2 months after discharge from hospitalization for the index myocardial infarction. Women were required to be postmenopausal or surgically sterile. All participants received dietary counseling according to the National Cholesterol Education Program Step 1 guidelines. After the screening visits were completed, eligible patients returned for a randomization visit, during which they were assigned to receive either pravastatin (40 mg/d) or identically appearing placebo by means of a telephone call from a clinical center to the Data Coordinating Center. The patient was the unit of randomization, randomization was stratified within each clinical center, and the allocation schedule was generated by computer. The code for treatment assignment was maintained only at the Data Coordinating Center. The primary trial outcome was fatal coronary artery disease or confirmed nonfatal myocardial infarction. For the primary analysis of the treatment effects in subgroups, we used an expanded end point (death from coronary artery disease, nonfatal myocardial infarction, angioplasty, or coronary artery bypass grafting), called major coronary events. Statistical Analysis All analyses were done on an intention-to-treat basis. P values (all of which were two-sided) less than 0.05 were deemed statistically significant. Baseline characteristics in the two treatment groups were determined by using the standard z-test for continuous variables and chi-square tests for categorical variables [40]. All hypothesis testing and risk reductions (with their CIs) were assessed by using the Cox proportional-hazards model. Kaplan-Meier survival curves for the control and pravastatin groups were calculated [41]. The relative risk reduction was calculated as 1 the hazard ratio. The upper and lower bounds of the 95% CIs for the relative risk reductions were applied to the rates in the placebo group to compute the CI for absolute risk reduction, and these bounds were inverted to provide the CIs for the number of patients needed to treat to prevent an event. To determine whether imbalances in risk factors at baseline could have affected the estimates of risk reduction attributable to therapy, we performed subsidiary multivariate analyses that included the following covariates: age, sex, baseline lipid levels, smoking, diabetes, hypertension, and left ventricular ejection fraction. Potential clinical center effects were assessed by including 79 indicator variables to denote the 80 clinical centers in the Cox proportional-hazards analysis. We used SAS software, version 6.12 (SAS Institute, Cary, North Carolina), to execute all analyses. Role of the Study Sponsor The CARE trial was an investigator-initiated study proposed to and funded by Bristol-Myers Squibb. The data were collected and analyzed by and are now maintained at the Coordinating Center, University of Texas School of Public Health. The sponsor is entitled to comment on manuscripts before submission. The authors may consider these comments, but the rights to publication reside contractually with the investigators. The sponsor, a member of the Executive Committee of the trial, was contractually required to fund the study until its conclusion. The sponsor maintained information on adverse events and other trial data, as required by federal regulations. Results Screening and Exclusion before Randomization From a total of 11 207 patients identified from records in hospitals and ambulatory practices for possible inclusion in the CARE trial, 3244 (29%) were at least 65 years of age (hereafter referred to as older patients). Of these 3244 older patients, 1139 (35%) qualified for the trial. An additional 144 patients reached the age of 65 years between their screening date and randomization; thus, 1283 older patients were randomly assigned in the CARE trial. A similar percentage of the patients younger than 65 years of age (hereafter referred to as younger patients)-39% (3020 patients)-qualified for the trial. Older patients were less likely than younger patients to be ineligible because of elevated total cholesterol, LDL cholesterol, or triglyceride levels (8% and 12%, respectively). However, older patients were more likely than younger patients to be ineligible because criteria for myocardial infarction were not met (61% and 53%, respectively) (P < 0.05 for all comparisons). Baseline Characteristics The median follow-up was 5 years (25th and 75th percentiles, 4.3 and 5.4 years). The mean age of the older patients was 69 years at randomization (25th and 75th percentiles, 66 and 73 years) and 74 years at the end of the trial. Baseline coronary risk factors significantly differed between the two age groups (Table 1). Older patients more frequently were female (18% compared with 12% of younger patients), had hypertension (48% compared with 40%), and had diabetes (19% compared with 12%). In addition, they were more likely to have had a second previous myocardial infarction (21% compared with 15%) and less frequently were current smokers (12% compared with 24%), had ever smoked (70% compared with 81%), or had a family history of coronary artery disease (33% compared with 44%) (P < 0.05 for all comparisons). Table 1. Baseline Characteristics of Patients Younger Than 65 Years of Age and Those 65


Journal of the American College of Cardiology | 2002

Right ventricular dysfunction and risk of heart failure and mortality after myocardial infarction.

Leonardo A. M. Zornoff; Hicham Skali; Marc A. Pfeffer; Martin St. John Sutton; Jean L. Rouleau; Gervasio A. Lamas; Ted Plappert; Jacques R. Rouleau; Lemuel A. Moyé; Sandra J. Lewis; Eugene Braunwald; Scott D. Solomon

OBJECTIVES The aim of this study was to determine the prognostic value of right ventricular (RV) function in patients after a myocardial infarction (MI). BACKGROUND Right ventricular function has been shown to predict exercise capacity, autonomic imbalance and survival in patients with advanced heart failure (HF). METHODS Two-dimensional echocardiograms were obtained in 416 patients with left ventricular (LV) dysfunction (ejection fraction [LVEF] < or = 40%) from the Survival And Ventricular Enlargement (SAVE) echocardiographic substudy (mean 11.1 +/- 3.2 days post infarction). Right ventricular function from the apical four-chamber view, assessed as the percent change in the cavity area from end diastole to end systole (fractional area change [FAC]), was related to clinical outcome. RESULTS Right ventricular function correlated only weakly with the LVEF (r = 0.12, p = 0.013). On univariate analyses, the RV FAC was a predictor of mortality, cardiovascular mortality and HF (p < 0.0001 for all) but not recurrent MI. After adjusting for age, gender, diabetes mellitus, hypertension, previous MI, LVEF, infarct size, cigarette smoking and treatment assignment, RV function remained an independent predictor of total mortality, cardiovascular mortality and HF. Each 5% decrease in the RV FAC was associated with a 16% increased odds of cardiovascular mortality (95% confidence interval 4.3% to 29.2%; p = 0.006). CONCLUSIONS Right ventricular function is an independent predictor of death and the development of HF in patients with LV dysfunction after MI.


Journal of the American College of Cardiology | 1998

Effect of pravastatin on cardiovascular events in women after myocardial infarction: the Cholesterol and Recurrent Events (CARE) trial

Sandra J. Lewis; Frank M. Sacks; Jayne Mitchell; Cara East; Stephen P. Glasser; Sheren Kell; Rebecca Letterer; Marian C. Limacher; Lemuel A. Moyé; Jean L. Rouleau; Marc A. Pfeffer; Eugene Braunwald

OBJECTIVES We sought to determine the effect of pravastatin on recurrent cardiovascular events in women with average cholesterol levels after myocardial infarction (MI). BACKGROUND Little information is available on the effectiveness of lipid lowering in secondary prevention of coronary heart disease (CHD) in women; in particular, those with CHD and average cholesterol levels. METHODS In the Cholesterol and Recurrent Events (CARE) trial, 576 postmenopausal women, between 3 and 20 months after MI, with a total cholesterol level <240 mg/dl and a low density lipoprotein cholesterol level 115 to 174 mg/dl, were randomized to receive pravastatin 40 mg/day or matching placebo for a median follow-up period of 5 years. The main outcome measures were combined coronary events (coronary death, nonfatal MI, percutaneous transluminal coronary angioplasty [PTCA] or coronary artery bypass graft surgery [CABG]), the primary trial end point (coronary death or nonfatal MI) and stroke. RESULTS Women treated with pravastatin had a risk reduction of 43% for the primary end point (p = 0.035), 46% for combined coronary events (p = 0.001), 48% for PTCA (p = 0.025), 40% for CABG (p = 0.14) and 56% for stroke (p = 0.07). The 3,583 men in the CARE trial also showed a reduction in risk, but the magnitude tended to be less. Pravastatin improved plasma lipids similarly in men and women. There were no differences in risk of coronary events in the placebo group between men and women. Minor differences between men and women were present in baseline characteristics and treatment for MI, in general, conferring a higher risk status and a lower incidence of CABG in the women. CONCLUSIONS Pravastatin led to significant early reduction of a wide range of cardiovascular events in post-MI women with average cholesterol levels.


Circulation | 2007

Effect of High-Dose Atorvastatin on Hospitalizations for Heart Failure Subgroup Analysis of the Treating to New Targets (TNT) Study

Kiran K. Khush; David D. Waters; Vera Bittner; Prakash Deedwania; John J. P. Kastelein; Sandra J. Lewis; Nanette K. Wenger

Background— Statins reduce the rate of major cardiovascular events in high-risk patients, but their potential benefit as treatment for heart failure (HF) is less clear. Methods and Results— Patients (n=10 001) with stable coronary disease were randomized to treatment with atorvastatin 80 or 10 mg/d and followed up for a median of 4.9 years. A history of HF was present in 7.8% of patients. A known ejection fraction <30% and advanced HF were exclusion criteria for the study. A predefined secondary end point of the study was hospitalization for HF. The incidence of hospitalization for HF was 2.4% in the 80-mg arm and 3.3% in the 10-mg arm (hazard ratio, 0.74; 95% confidence interval, 0.59 to 0.94; P=0.0116). The treatment effect of the higher dose was more marked in patients with a history of HF: 17.3% versus 10.6% in the 10- and 80-mg arms, respectively (hazard ratio, 0.59; 95% confidence interval, 0.4 to 0.88; P=0.009). Among patients without a history of HF, the rates of hospitalization for HF were much lower: 1.8% in the 80-mg group and 2.0% in the 10-mg group (hazard ratio, 0.87; 95% confidence interval, 0.64 to 1.16; P=0.34). Only one third of patients hospitalized for HF had evidence of preceding angina or myocardial infarction during the study period. Blood pressure was almost identical during follow-up in the treatment groups. Conclusions— Compared with a lower dose, intensive treatment with atorvastatin in patients with stable coronary disease significantly reduces hospitalizations for HF. In a post hoc analysis, this benefit was observed only in patients with a history of HF. The mechanism accounting for this benefit is unlikely to be due primarily to a reduction in interim coronary events or differences in blood pressure.


Annals of Internal Medicine | 2007

Outcomes of Using High- or Low-Dose Atorvastatin in Patients 65 Years of Age or Older with Stable Coronary Heart Disease

Nanette K. Wenger; Sandra J. Lewis; David M. Herrington; Vera Bittner; Francine K. Welty

Context Data on the benefits of intensive lipid-lowering treatment for elderly persons with heart disease are sparse. Contribution This secondary analysis of a trial examined outcomes of 3809 adults 65 years of age or older with coronary heart disease who were randomly assigned to receive atorvastatin, 80 or 10 mg/d. Patients achieved average low-density lipoprotein cholesterol levels of approximately 1.81 mmol/L (70 mg/dL) and 2.59 mmol/L (100 mg/dL), respectively. Fewer patients who received 80 mg of atorvastatin had major fatal or nonfatal cardiovascular events than did those who received 10 mg of atorvastatin (10.3% vs. 12.6%). Caution The researchers could not determine whether benefits were due to the higher statin dose, lower achieved cholesterol levels, or both factors. The Editors The age profile of the population in most industrialized countries is changing as life expectancy increases. Because cardiovascular risk increases steadily with age, this demographic transition is associated with an increase in the burden of chronic cardiovascular disease (CVD), including coronary heart disease (CHD) and stroke (1). Subgroup analyses from large, randomized, placebo-controlled clinical trials (24) demonstrated that decreasing low-density lipoprotein (LDL) cholesterol levels with statin therapy statistically significantly reduced the risk for CHD in older persons. On the basis of these early trial data, the Third Report of the National Cholesterol Education Program Adult Treatment Panel (5) recommended that persons older than 65 years of age should not be denied the benefits of lipid-lowering therapy. Since publication of the panels report, results of the Heart Protection Study (6) and PROSPER (Prospective Study of Pravastatin in the Elderly at Risk) (7) further support the efficacy and safety of statin treatment in older persons. The outcomes of these 2 studies, along with previous evidence, led the National Cholesterol Education Program to conclude that these data provide a strong justification for intensive LDL cholesterollowering therapy in high-risk older persons with established CVD (8). Recent secondary prevention guidelines from the American Heart Association (AHA) and the American College of Cardiology (ACC) state that it is reasonable to reduce LDL cholesterol levels to less than 1.8 mmol/L (<70 mg/dL) in any patient with established CHD (9). In the ACC and AHA guidelines (10), the writing group acknowledged that elderly patients were underrepresented in many clinical trials and urged physicians and patients to participate in trials that will provide additional evidence for therapeutic strategies in elderly patients. In the TNT (Treating to New Targets) study, intensive lipid-lowering treatment with 80 mg of atorvastatin in patients with stable CHD provided clinically significant benefit beyond treatment with 10 mg of atorvastatin (11). Our prespecified secondary analysis reports data from the TNT study on the efficacy and safety of high-dose atorvastatin treatment in patients 65 years of age or older. Methods Study Design and Patients Details of the TNT study design and outcome measures are published elsewhere (11, 12). After a washout phase, men and women 35 to 75 years of age with established CHD, LDL cholesterol levels between 3.4 and 6.5 mmol/L (130 and 250 mg/dL), and triglyceride levels less than 6.8 mmol/L (<600 mg/dL) were eligible to enter an 8-week, open-label, run-in period with atorvastatin, 10 mg/d. At the end of the run-in phase, 10001 patients with LDL cholesterol levels less than 3.4 mmol/L (<130 mg/dL) were randomly assigned to receive double-blind therapy with atorvastatin, 10 or 80 mg/d. The time of randomization was used as the baseline, and patients were followed for a median of 4.9 years. The primary study outcome was the time to the first occurrence of a major cardiovascular event, defined as death due to CHD, nonfatal nonprocedure-related myocardial infarction, resuscitated cardiac arrest, and fatal or nonfatal stroke. The prespecified secondary outcomes were a major coronary event, a cerebrovascular event, peripheral arterial disease, hospitalization with a primary diagnosis of congestive heart failure, death from any cause, any cardiovascular event, and any coronary event. An independent end point committee that was blinded to treatment assignment adjudicated all primary and secondary outcomes. Statistical Analysis We tested the statistical significance of treatment effect on end points by using the log-rank test. We calculated hazard ratios with 95% CIs from a Cox regression model that we present where appropriate. We performed homogeneity tests for treatment interaction with age by using a Cox proportional hazards model to determine whether the treatment effects observed in patients 65 years of age or older differed from those in patients younger than 65 years. Role of the Funding Source The TNT study was funded by Pfizer. The steering committee developed the protocol in collaboration with the funding source and was responsible for the final version. ICON Clinical Research, North Wales, Pennsylvania, managed all data. ICON and Pfizer provided site monitoring throughout the study. The data were analyzed by the funding source according to the statistical analysis plan approved by the steering committee. The steering committee had unrestricted, request-based access to the study data, which were retained by the funding source, and developed the article independently without constraints from the sponsor. Results Sample Of 10001 patients randomly assigned in the overall TNT study cohort, 3809 (38%) were 65 years of age or older (1872 received 10 mg of atorvastatin and 1937 received 80 mg). Baseline characteristics and LDL, high-density lipoprotein, and total cholesterol and triglyceride levels were similar between the 2 treatment groups (Table 1). The mean age of the older cohort was 69.9 years. In this group, 2033 patients were 65 to 69 years of age (1000 received 10 mg of atorvastatin and 1033 received 80 mg) and 1776 patients were 70 years of age or older (872 received 10 mg and 904 received 80 mg). The demographic and cardiovascular profiles of patients age 70 years or older were similar to those of the total elderly cohort, including lipid values and previous CVD at baseline. Table 1. Baseline Characteristics of Patients* Lipid Values During the open-label period, LDL cholesterol levels among patients 65 years of age or older decreased from 4.2 mmol/L (163 mg/dL) to 2.5 mmol/L (96 mg/dL). At week 12, mean LDL cholesterol levels were 1.9 mmol/L (72 mg/dL) among those who received 80 mg of atorvastatin and 2.5 mmol/L (97 mg/dL) among those who received 10 mg. Levels of LDL cholesterol in both groups remained stable for the duration of the study. Total cholesterol and triglyceride levels decreased from baseline to week 12 in patients who received 80 mg of atorvastatin and were maintained at this reduced level for the duration of the study. High-density lipoprotein cholesterol levels changed little from baseline levels: At study end, levels had increased by 0.3% for patients who received 10 mg and 0.17% for patients who received 80 mg. Figure 1 shows postrandomization LDL cholesterol and triglyceride levels among patients 65 years of age or older. Figure 1. Mean low-density lipoprotein ( LDL ) cholesterol levels ( top ) and mean triglyceride levels ( bottom ) among patients 65 years of age or older. To convert LDL cholesterol values to mg/dL, divide by 0.02586. To convert triglyceride values to mg/dL, divide by 0.01129. Efficacy Outcomes among Older Patients Among patients 65 years of age or older, a primary event occurred in 199 patients (10.3%) who received 80 mg of atorvastatin and 235 patients (12.6%) who received 10 mg. This is a 2.3% absolute reduction in the rate of major cardiovascular events and a 19% relative reduction in risk in favor of the high-dose group (hazard ratio, 0.81 [95% CI, 0.67 to 0.98]; P= 0.032) (Table 2). After adjustment for well-established risk factors (sex, race, smoking status, history of diabetes, and history of hypertension), the risk reductions associated with 80 mg were similar to the unadjusted results (hazard ratio, 0.81 [CI, 0.67 to 0.98]; P= 0.032). The number needed to treat for benefit for 80 mg versus 10 mg was 35. This value is the number of patients who need to be treated to prevent 1 cardiovascular event over 4.9 years. Table 2. Estimated Hazard Ratios for Individual Components of the Primary Outcome among Patients 65 Years of Age or Older* Table 2 shows the incidence of each component of the primary composite outcome among older patients. Rates of death due to CHD, nonfatal nonprocedure-related myocardial infarction, and fatal and nonfatal stroke (ischemic, embolic, hemorrhagic, or unknown origin) were lower in the 80-mg group than in the 10-mg group. For each individual component, however, the difference was not statistically significant. Eight patients (0.4%) who received 80 mg and 15 patients (0.8%) who received 10 mg had hemorrhagic stroke, which caused 3 deaths in each group. The risk for any cardiovascular event (P< 0.001), a major coronary event (P= 0.128), any coronary event (P< 0.001), a cerebrovascular event (P= 0.010), and hospitalization for congestive heart failure (P= 0.008) was lower in the 80-mg group than in the 10-mg group. The 2 groups did not statistically significantly differ for all-cause mortality and for rates of death due to cardiovascular and noncardiovascular causes. The rate of death due to cardiovascular causes was lower in the 80-mg group than in the 10-mg group (78 patients [4.0%] vs. 83 patients [4.4%]; hazard ratio, 0.91 [CI, 0.67 to 1.24]; P= 0.55). However, more patients in the 80-mg group than the 10-mg group died of noncardiovascular causes (98 patients [5.1%] vs. 76 patients [4.1%]; hazard ratio, 1.26 [CI, 0.93 to 1.70]; P= 0.129). These hazard ratios are consistent with those in the overall


BMC Public Health | 2007

Prevalence of self-reported diagnosis of diabetes mellitus and associated risk factors in a national survey in the US population: SHIELD (Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes)

Harold E. Bays; Debbra D. Bazata; Nathaniel G. Clark; James R. Gavin; Andrew J. Green; Sandra J. Lewis; Michael L. Reed; Walter F. Stewart; Richard H. Chapman; Kathleen M. Fox; Susan Grandy

BackgroundStudies derived from continuous national surveys have shown that the prevalence of diagnosed diabetes mellitus in the US is increasing. This study estimated the prevalence in 2004 of self-reported diagnosis of diabetes and other conditions in a community-based population, using data from the Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes (SHIELD).MethodsThe initial screening questionnaire was mailed in 2004 to a stratified random sample of 200,000 households in the US, to identify individuals, age ≥ 18 years of age, with diabetes or risk factors associated with diabetes. Follow-up disease impact questionnaires were then mailed to a representative, stratified random sample of individuals (n = 22,001) in each subgroup of interest (those with diabetes or different numbers of risk factors for diabetes). Estimated national prevalence of diabetes and other conditions was calculated, and compared to prevalence estimates from the National Health and Nutrition Examination Survey (NHANES) 1999–2002.ResultsResponse rates were 63.7% for the screening, and 71.8% for the follow-up baseline survey. The SHIELD screening survey found overall prevalence of self-reported diagnosis of diabetes (either type 1 or type 2) was 8.2%, with increased prevalence with increasing age and decreasing income. In logistic regression modeling, individuals were more likely to be diagnosed with type 2 diabetes if they had abdominal obesity (odds ratio [OR] = 3.50; p < 0.0001), BMI ≥28 kg/m2 (OR = 4.04; p < 0.0001), or had been diagnosed with dyslipidemia (OR = 3.95; p < 0.0001), hypertension (OR = 4.82; p < 0.0001), or with cardiovascular disease (OR = 3.38; p < 0.0001).ConclusionThe SHIELD design allowed for a very large, community-based sample with broad demographic representation of the population of interest. When comparing results from the SHIELD screening survey (self-report only) to those from NHANES 1999–2002 (self-report, clinical and laboratory evaluations), the prevalence of diabetes was similar. SHIELD allows the identification of respondents with and without a current diagnosis of the illness of interest, and potential longitudinal evaluation of risk factors for future diagnosis of that illness.


The American Journal of Medicine | 2009

Prevention and Treatment of Atherosclerosis: A Practitioner's Guide for 2008

Sandra J. Lewis

Atherosclerosis causes nearly 75% of cardiovascular-related deaths and is found in 80% to 90% of adults >/=30 years old in the United States. Successful treatment minimizes lifetime chances of cardiovascular events, morbidity, and mortality. Risk factors for atherosclerosis should be monitored, beginning in childhood, even in asymptomatic patients. Modifiable factors (e.g., blood pressure, smoking, serum lipids) and nonmodifiable factors (e.g., age, family history) are important in the overall assessment. Clinicians and patients can partner to produce an individualized treatment plan by choosing from a variety of standard approaches. In some patients, improved dietary choices, increased exercise, and smoking cessation will reduce risk to an acceptable degree. To lower risk further, lipid-lowering pharmacotherapy and antihypertensive medication may be combined with these lifestyle improvements. For most of these patients, reducing low-density lipoprotein cholesterol is the most important lipid-lowering goal, and it is best achieved with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin). Some patients may benefit from adjunctive therapies that have proven effects (e.g., niacin, fibrates, plant stanols/sterols, omega-3 fatty acids). Antihypertensive regimens may involve stepwise adjustments of multiple medications. Good clinical judgment and communication of expectations and goals are critical for effective management of atherosclerosis.


Heart | 2007

Beneficial effects of aggressive low-density lipoprotein cholesterol lowering in women with stable coronary heart disease in the Treating to New Targets (TNT) study

Nanette K. Wenger; Sandra J. Lewis; Francine K. Welty; David M. Herrington; Vera Bittner

Objective: To examine by secondary analysis of the Treating to New Targets (TNT) study whether the benefits of intensive versus standard levels of lipid lowering are equally applicable to women. Methods: A total of 10 001 patients (1902 women) with stable coronary heart disease (CHD) were randomised to double-blind treatment with atorvastatin 10 or 80 mg/day for a median follow-up of 4.9 years. Results: In women and men, intensive treatment with atorvastatin 80 mg significantly reduced the rate of major cardiovascular events compared with atorvastatin 10 mg. Among women, the relative and absolute reductions were 27% and 2.7%, respectively (hazard ratio (HR) = 0.73, 95% confidence interval (CI) 0.54 to 1.00, p = 0.049). In men, the corresponding rate reductions were 21% and 2.2% (HR = 0.79, 95% CI 0.69 to 0.91, p = 0.001). The number needed to treat value (to prevent one cardiovascular event over 4.9 years compared with patients treated with atorvastatin 10 mg) for atorvastatin 80 mg was 29 for women and 30 for men. Rates of death of non-cardiovascular origin in the atorvastatin 80 mg and atorvastatin 10 mg were 3.6% and 1.6%, respectively (p = 0.004) among women, and 2.8% and 3.1% (p = 0.47) among men. Conclusion: Intensive lipid-lowering treatment with atorvastatin 80 mg produced significant reductions in relative risk for major cardiovascular events compared with atorvastatin 10 mg in both women and men with stable CHD.


International Journal of Clinical Practice | 2008

Self‐reported prevalence and awareness of metabolic syndrome: findings from SHIELD

Sandra J. Lewis; H. W. Rodbard; Kathleen M. Fox; Susan Grandy

Purpose:  This study assessed awareness of metabolic syndrome and evaluated health knowledge, attitudes and behaviours of respondents at risk.

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Vera Bittner

University of Alabama at Birmingham

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Francine K. Welty

Beth Israel Deaconess Medical Center

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Marc A. Pfeffer

Brigham and Women's Hospital

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Eugene Braunwald

Brigham and Women's Hospital

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