Biomedical subjects
Publications and source records attributed to Allen J Taylor.
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CONTEXT: Poor medication adherence diminishes the health benefits of pharmacotherapies. Elderly patients with coronary risk factors frequently require treatment with multiple medications, placing them at increased risk for nonadherence. OBJECTIVE: To test the efficacy of a comprehensive pharmacy care program to improve medication adherence and its associated effects on blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C). DESIGN, SETTING, AND PATIENTS: A multiphase, prospective study with an observational phase and a randomized controlled trial conducted at the Walter Reed Army Medical Center of 200 community-based patients aged 65 years or older taking at least 4 chronic medications. The study was conducted from June 2004 to August 2006. INTERVENTION: After a 2-month run-in phase (measurement of baseline adherence, BP, and LDL-C), patients entered a 6-month intervention phase (standardized medication education, regular follow-up by pharmacists, and medications dispensed in time-specific packs). Following the intervention phase, patients were randomized to continued pharmacy care vs usual care for an additional 6 months. MAIN OUTCOME MEASURES: Primary end point of the observation phase was change in the proportion of pills taken vs baseline; secondary end points were the associated changes in BP and LDL-C. Primary end point of the randomization phase was the between-group comparison of medication persistence. RESULTS: A total of 200 elderly patients (77.1% men; mean [SD] age, 78 [8.3] years), taking a mean (SD) of 9 (3) chronic medications were enrolled. Coronary risk factors included drug-treated hypertension in 184 patients (91.5%) and drug-treated hyperlipidemia in 162 (80.6%). Mean (SD) baseline medication adherence was 61.2% (13.5%). After 6 months of intervention, medication adherence increased to 96.9% (5.2%; P<.001) and was associated with significant improvements in systolic BP (133.2 [14.9] to 129.9 [16.0] mm Hg; P = .02) and LDL-C (91.7 [26.1] to 86.8 [23.4] mg/dL; P = .001). Six months after randomization, the persistence of medication adherence decreased to 69.1% (16.4%) among those patients assigned to usual care, whereas it was sustained at 95.5% (7.7%) in pharmacy care (P<.001). This was associated with significant reductions in systolic BP in the pharmacy care group (-6.9 mm Hg; 95% CI, -10.7 to -3.1 mm Hg) vs the usual care group (-1.0 mm Hg; 95% CI, -5.9 to 3.9 mm Hg; P = .04), but no significant between-group differences in LDL-C levels or reductions. CONCLUSIONS: A pharmacy care program led to increases in medication adherence, medication persistence, and clinically meaningful reductions in BP, whereas discontinuation of the program was associated with decreased medication adherence and persistence. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00393419
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BACKGROUND: Ultralow-fat diets are known to reduce high-density lipoprotein cholesterol (HDL-C) levels. In the setting of a multicomponent lifestyle intervention program, relationships between exercise variables and HDL-C levels were examined to determine whether exercise moderates this dietary effect on serum lipids and apolipoproteins. METHODS: We performed a 3-month, prospective, nonrandomized lifestyle intervention study (< or = 10% dietary fat; aerobic exercise [180 min/wk], group support, and yoga [60 min/day]) in 120 subjects with or at risk for coronary artery disease. RESULTS: After 3 months, dietary fat intake was reduced to 8.7% +/- 2.6% of total intake and the median weekly exercise time was 194 minutes. High-density lipoprotein cholesterol levels decreased by 8.3 +/- 11.3 mg/dL (P < .001), and triglyceride levels increased by 17.6 +/- 102.7 mg/dL (P = .026). A small dense low-density lipoprotein cholesterol (LDL-C) phenotype emerged indicated by a 13.8% LDL-C reduction accompanied by only a 2.3% reduction in apolipoprotein B levels (P = .064). Among subjects with exercise amounts less than those of the group median, HDL-C reductions were greater in those with more than (-13.5 +/- 16.0 mg/dL) versus less than (-2.5 +/- 7.5 mg/dL) the median reductions in fat intake (P = .026). Even among subjects who exercised > 194 min/wk, HDL-C was reduced compared with baseline (-7.4 +/- 7.9 mg/dL, P < .001). CONCLUSIONS: An ultralow-fat diet as a component of a comprehensive lifestyle intervention induces reductions in HDL-C and the emergence of a dyslipidemic lipid profile. Aerobic exercise only partially mitigates this effect.
BACKGROUND: Patients with diabetes mellitus (DM) are at increased risk of contrast-associated nephropathy irrespective of their baseline creatinine (Cr). We tested the efficacy of N-acetylcysteine (NAC) relative to hydration in unselected patients (irrespective of baseline Cr) with DM. METHODS: We conducted a randomized open-label study comparing hydration alone (combined oral and rapid intravenous hydration, n = 69) to NAC plus hydration (similar hydration protocol plus NAC 600 mg BID x 4 doses, n = 68) in diabetic patients (mean age 65 +/- 10 years, 65% men) undergoing elective coronary angiography. The primary end point was the mean change in serum Cr measured up to 96 hours postangiography. RESULTS: Baseline Cr was 1.14 +/- 0.43 mg/dL (Cr > or = 1.3 mg/dL in 37 subjects). Baseline characteristics including blood urea nitrogen, Cr, and contrast volume were similar between the 2 groups. The mean Cr change in the NAC group was 0.14 +/- 0.47 versus 0.08 +/- 0.11 mg/dL in the hydration only group (P = NS). Contrast-associated nephropathy, defined as a > or = 0.5 mg/dL increase in Cr, was significantly more common in the NAC group, 9.2% versus 1.4%, P = .043. Similar results were found in the subgroup of participants with either an increased baseline serum Cr (> or = 1.3 mg/dL) or in those receiving high contrast volumes (> 100 mL). CONCLUSIONS: N-Acetylcysteine provides no benefit over an aggressive hydration protocol in patients with DM undergoing coronary angiography.
Carotid intima-media thickness (CIMT) testing is recognized as a valid method for the noninvasive assessment of atherosclerosis. In addition to its association with known cardiovascular risk factors and both prevalent and incident coronary heart disease, the rate of CIMT progression is directly related to the risk for future cardiovascular events. Subsequently, CIMT has been a valuable research tool in clinical trials in the assessment of therapeutic agents directed against atherosclerosis. An overview of CIMT testing including its precise measurement, establishment as a surrogate for atherosclerosis by epidemiologic trials, role in clinical trials, and potential applications in both primary and secondary coronary heart disease prevention is presented.
INTRODUCTION: Military operations may represent a high-risk environment for venous thromboembolism (VTE). We sought to identify and describe cases of venous thromboembolism among US military personnel serving in Southwest Asia, and estimate relative disease rates compared to non-deployed personnel. MATERIALS AND METHODS: Retrospective review of imaging archives, hospital discharge codes, case logs and autopsy records for the diagnosis of deep vein thrombosis or pulmonary embolism occurring from 1 March 2003 through 29 February 2004 among U.S. military personnel deployed to Southwest Asia. Rates of disease in deployed and non-deployed active-duty soldiers were estimated using personnel data and deployment experience obtained from automated rosters. RESULTS: Forty cases of venous thromboembolism were identified. The case-fatality rate was 16% (3/19) among those with pulmonary embolism. Antecedent trauma followed by prolonged air evacuation was present in 55% (22/40). Compared to trauma-associated cases, non-trauma cases were more commonly over 40 years old (44% vs. 5%; p<0.05), assigned to a transportation or quartermaster company (56% vs. 14%; p<0.05), or had a history of remote venous thromboembolism (31% vs. 0%; p<0.05). The overall incidence among deployed active-duty soldiers was 22.1/100,000 person-years. Compared to non-deployed active-duty soldiers, the age-adjusted incidence rate ratio was 1.06 (CI(0.95) 0.68-1.67). CONCLUSIONS: VTE rates among deployed soldiers are relatively low compared to the general population, and are comparable to non-deployed soldiers. Fatalities from PE are not uncommon, and vigilance among clinicians remains warranted. Trauma followed by prolonged air evacuation or ground transport during military operations may represent unique interactive risk factors for venous thromboembolism.
BACKGROUND: Whether the previously reported underutilization of standard-of-care medications in the management of patients with acute myocardial infarction (AMI) persists in more recent years or differs by ward of admission has not been reported. METHODS: We performed a retrospective cross-sectional study of patients hospitalized with a discharge diagnosis of incident AMI to a Department of Defense hospital (Walter Reed Army Medical Center, Washington, DC) from 2001 through 2004. Use of beta-blockers and aspirin at the time of discharge after AMI was assessed according to Modification of Diet in Renal Disease (MDRD) estimated glomerular filtration rate (eGFR) in milliliters per minute per 1.73 m2, stratified by admission to the coronary care unit (CCU) versus other wards. Adjusted odds ratios for discharge beta-blocker and aspirin therapy were calculated by using logistic regression. RESULTS: Among 431 patients, overall discharge use of beta-blockers was 86.8%, and aspirin, 86.8%, both significantly greater after CCU admission than admission to other wards (93%, aspirin use; 91.7%, beta-blocker use; P < 0.001 and P < 0.001). In logistic regression, CCU admission was the only independent factor associated with either beta-blocker or aspirin use; MDRD eGFR was not associated significantly with beta-blocker and aspirin use regardless of admission to the CCU or non-CCU. CONCLUSION: Future studies of disparities in use of standard-of-care medications after AMI according to renal function should account for the primary site of admission, particularly CCU versus others. In addition, legitimate contraindications to the use of beta-blockers and aspirin may be subtle, including appropriate end-of-life decisions.
The authors examined the relationship between calcified coronary atherosclerosis and an array of cardiovascular risk factors in sequential logistic models to determine the extent to which these markers overlap in their identification of patients at risk for developing coronary heart disease. The prevalence of coronary artery calcium using electron beam computed tomography was 19.4% in this cross-sectional study of a prospective, consecutive, screening cohort of 1999 healthy United States Army personnel (aged 39-50 years). The proportion of the total variance of coronary artery calcium explained by sequential logistic models incorporating conventional, emerging, hereditary, lifestyle, and psychosocial cardiovascular risk variables increased progressively from 9.7% to 14.5%. The best-fit logistic model for the prediction of coronary artery calcium identified age, male gender, Framingham risk score, total cholesterol, high-density lipoprotein cholesterol, triglycerides, smoking, a family history of coronary heart disease, white race, physical inactivity, and lower depression scores as significant independent correlates of coronary artery calcium. These data indicate that the explanatory power of models for atherosclerosis can be significantly improved with the use of emerging, heredity, lifestyle, and psychosocial factors. The large residual variance, however, supports the potential of atherosclerosis imaging to incrementally and independently identify coronary heart disease risk.
Numerous studies have evaluated the association between antioxidants and coronary atherosclerosis but have been limited by its study among individuals with advanced atherosclerosis. The authors studied 865 consecutive patients, 39-45 years of age, without known coronary artery disease and presenting for a periodic physical examination. Antioxidant intake was assessed with the Block Dietary Questionnaire, and coronary atherosclerosis was identified by measuring coronary artery calcification using electron beam computed tomography. The mean age was 42 (+/-2), 83% were male, and the prevalence of coronary artery calcification was 20%. Vitamin supplements were used by 56% of the participants, and the mean (+/-SD) daily intake (dietary plus supplemental) of vitamins A, C, and E were 1683 mg (+/-1245), 371 mg (+/-375), and 97 mg (+/-165), respectively. There was no significant correlation between coronary artery calcification score and individual vitamin or total antioxidant vitamin intake, even after adjusting for traditional cardiac risk factors. The highest quartile of vitamin E was positively associated with calcification (odds ratio=1.77; 95% confidence interval, 1.02-3.06). Antioxidant vitamin intake is not significantly related to coronary artery calcification, implying that there is no effect on the development of early coronary atherosclerosis. High doses of vitamin E may confer an increased risk of calcified atherosclerosis.
OBJECTIVE: The ARBITER 2 trial showed that extended-release niacin (ERN) when added to statin monotherapy slowed the progression of carotid atherosclerosis over 12 months. Whether longer treatment with ERN would have a greater effect on carotid intima-media thickness (CIMT) is unknown. RESEARCH DESIGN AND METHODS: We examined the long-term effects of ERN on high density lipoprotein (HDL-C) cholesterol and CIMT during 12-24 months treatment with ERN in ARBITER 2 participants who were either continued or were crossed over (from placebo) to ERN 1000 mg daily. MAIN OUTCOME MEASURES: Among 149 subjects completing ARBITER 2, 130 (88%) enrolled in ARBITER 3. The prespecified primary endpoints were the within-group change in CIMT and HDL-C in patients receiving placebo for 12 months (n = 71), ERN for 12 months (comprised of subjects from ERN treatment during ARBITER 2 (n = 78) and those crossed over to ERN from placebo after ARBITER 2 (n = 47)), and ERN for 24 months spanning ARBITER 2 and 3 (n = 57). Five subjects discontinued the study due to flushing side effects. The study was completed by 104 subjects (47 crossed over from placebo; 57 with ERN continued from ARBITER 2). RESULTS: HDL-C increased in the ERN group from 39.5 +/- 6.7 to 48.6 +/- 13.3 mg/dl (p < 0.001) along with modest reductions in LDL-C and TG. Among 125 participants treated with ERN for 12 months, there was a net regression of CIMT of -0.027 +/- 0.011 mm (p < 0.001 vs. placebo). Among 57 participants treated with ERN for 24 months, there was additional significant regression of CIMT of -0.041 +/- 0.021 mm (p = 0.001 vs. placebo). Controlling for changes in LDL and triglycerides, only changes in HDL-C were independently associated with regression of CIMT (beta = -0.25; p = 0.001). CONCLUSION: When added to statin therapy, ERN significantly increases HDL-C and induces atherosclerosis regression measured by CIMT over 24 months. Limitations to this study include its open-label design and the inability to relate CIMT effects to clinical outcomes.
OBJECTIVES: We sought to examine the independent predictive value of coronary artery calcium detection for coronary outcomes in a non-referred cohort of healthy men and women ages 40 to 50 years. BACKGROUND: Existing studies have suggested that coronary calcium might have incremental predictive value for coronary outcomes above standard coronary risk factors. However, additional data from non-referred and younger populations are needed. METHODS: Participants (n = 2,000; mean age 43 years) were evaluated with measured coronary risk variables and coronary calcium detected with electron beam tomography. Incident acute coronary syndromes and sudden cardiac death were ascertained via annual telephonic contacts, with follow-up (mean, 3.0 +/- 1.4 years; range, 1 to 6 years) in 99.2% of the cohort. RESULTS: Coronary calcium was found in 22.4% of men and 7.9% of women. A total of 9 acute events occurred in men at a mean age of 46 years, including 7 of 364 men with coronary calcium (1.95%) and 2 of 1,263 men without coronary calcium (0.16%; p < 0.0001 by log-rank). No events occurred in women. In these men, coronary calcium was associated with an 11.8-fold increased risk for incident coronary heart disease (CHD) (p = 0.002) in a Cox model controlling for the Framingham risk score. Among those with coronary artery calcification, the risk of coronary events increased incrementally across tertiles of coronary calcium severity (hazard ratio 4.3 per tertile). A family history of premature CHD was also predictive of incident events. The marginal cost effectiveness, assuming a 30% improvement in survival associated with primary prevention among at-risk men, was modeled to be 37,633 dollars per quality-adjusted life year saved. CONCLUSIONS: In young, asymptomatic men, the presence of coronary artery calcification provides substantial, cost-effective, independent prognostic value in predicting incident CHD that is incremental to measured coronary risk factors.
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Incident chest pain occurred in 30.3% of 1,743 asymptomatic healthy men and women who were followed for up to 4 years. Proportions of patients who had coronary artery calcium were similar among those who had no chest pain, noncardiac pain, atypical pain, or cardiac chest pain. Incident chest pain is common and should be examined according to a patient's pretest probability of developing coronary artery disease, without excessive influence of the presence of coronary artery calcium.
Cardiovascular disease is the leading cause of mortality for women in the United States. Coronary heart disease, which includes coronary atherosclerotic disease, myocardial infarction, acute coronary syndromes, and angina, is the largest subset of this mortality, with >240,000 women dying annually from the disease. Atherosclerotic coronary artery disease (CAD) is the focus of this consensus statement. Research continues to report underrecognition and underdiagnosis of CAD as contributory to high mortality rates in women. Timely and accurate diagnosis can significantly reduce CAD mortality for women; indeed, once the diagnosis is made, it does appear that current treatments are equally effective at reducing risk in both women and men. As such, noninvasive diagnostic and prognostic testing offers the potential to identify women at increased CAD risk as the basis for instituting preventive and therapeutic interventions. Nevertheless, the recent evidence-based practice program report from the Agency for Healthcare Research and Quality noted the paucity of women enrolled in diagnostic research studies. Consequently, much of the evidence supporting contemporary recommendations for noninvasive diagnostic studies in women is extrapolated from studies conducted predominantly in cohorts of middle-aged men. The majority of diagnostic and prognostic evidence in cardiac imaging in women and men has been derived from observational registries and referral populations that are affected by selection and other biases. Thus, a better understanding of the potential impact of sex differences on noninvasive cardiac testing in women may greatly improve clinical decision making. This consensus statement provides a synopsis of available evidence on the role of the exercise ECG and cardiac imaging modalities, both those in common use as well as developing technologies that may add clinical value to the diagnosis and risk assessment of the symptomatic and asymptomatic woman with suspected CAD.