Evaluation of the angiotensin II receptor blocker azilsartan medoxomil in African-American patients with hypertension.

The efficacy and safety of azilsartan medoxomil (AZL-M) were evaluated in African-American patients with hypertension in a 6-week, double-blind, randomized, placebo-controlled trial, for which the primary end point was change from baseline in 24-hour mean systolic blood pressure (BP). There were 413 patients, with a mean age of 52 years, 57% women, and baseline 24-hour BP of 146/91 mm Hg. Treatment differences in 24-hour systolic BP between AZL-M 40 mg and placebo (-5.

Using Bayesian Adaptive Trial Designs for Comparative Effectiveness Research: A Virtual Trial Execution.

Background: Bayesian and adaptive clinical trial designs offer the potential for more efficient processes that result in lower sample sizes and shorter trial durations than traditional designs.

Objective: To explore the use and potential benefits of Bayesian adaptive clinical trial designs in comparative effectiveness research.

Design: Virtual execution of ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) as if it had been done according to a Bayesian adaptive trial design.

Hypertension in african americans aged 60 to 79 years: statement from the international society of hypertension in blacks.

A 2014 hypertension guideline raised goal systolic blood pressure (SBP) from <140 mm Hg to <150 mm Hg for adults 60 years and older without diabetes mellitus (DM) or chronic kidney disease (CKD). The authors aimed to define the status of hypertension in black adults 60 to 79 years from the National Health and Nutrition Examination Survey 2005-2012 and provide practical guidance. Black patients were more often aware and treated (P≤.

Diabetes control through an educational intervention.

Objective: We evaluated the effect of an educational intervention administered to patients or/and physicians on the reduction in HbA(1c) and achieving diabetic control in a high-risk primarily Black inner-city population.

Methods: The study was designed as a four-arm randomized clinical trial where an educational program on diabetes was offered to physicians only, patients only, and both physicians and their patients, while the fourth arm did not receive any instruction. We built regression models at 24 months of follow-up to assess the likelihood of reaching glycemic goal as well as to measure the absolute reduction in HbA(1c) controlling for arm assignment, insulin use, race, age, sex, smoking, insulin use, and having achieved blood pressure control.

Do Bayesian adaptive trials offer advantages for comparative effectiveness research? Protocol for the RE-ADAPT study.

Background: Randomized clinical trials, particularly for comparative effectiveness research (CER), are frequently criticized for being overly restrictive or untimely for health-care decision making.

Purpose: Our prospectively designed REsearch in ADAptive methods for Pragmatic Trials (RE-ADAPT) study is a 'proof of concept' to stimulate investment in Bayesian adaptive designs for future CER trials.

Methods: We will assess whether Bayesian adaptive designs offer potential efficiencies in CER by simulating a re-execution of the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) study using actual data from ALLHAT.

Social networks help control hypertension.

Cardiovascular health disparities continue to pose a major public health problem. The authors evaluated the effect of education administered within social networks on the improvement of hypertension in 248 African Americans compared with historical controls. Patients formed clusters with peers and attended monthly hypertension education sessions.

A qualitative study to identify reasons for discharges against medical advice in the cardiovascular setting.

Background: Cardiovascular disease (CVD) is responsible for the largest number of discharges against medical advice (AMA). However, there is limited information regarding the reasons for discharges AMA in the CVD setting.

Objective: To identify reasons for discharges AMA among patients with CVD.

A qualitative evaluation of a citywide Community Health Partnership program.

While there have been numerous community-based programs in Baltimore, Maryland, aimed at helping patients access medical treatments and services, they historically were underutilized and did not operate synergistically. For that reason, sanofi-aventis, along with key stakeholders in Baltimore, developed the Community Health Partnership (CHP) to educate, empower, and connect patients to community health resources to enable patients to be more proactive about their health. The CHP utilizes a community health liaison (CHL) and a community health action team (CHAT) consisting of community health leaders who are hands-on activists and health care workers who coordinate activities and provide guidance for the CHP.

Diabetes knowledge in a high risk urban population.

This study explored the impact of an intensive educational intervention to patients on their knowledge and understanding of diabetes. This study was a hypothesis-testing, prospective study, with an experimental two-by-two factorial design. The educational programs were offered to physicians only, patients only, or both patients and their physicians.

β-Adrenergic blockers.

KEY POINTS AND PRACTICAL RECOMMENDATIONS: •  β-Blockers are appropriate treatment for patients with hypertension and those who have concomitant ischemic heart disease, heart failure, obstructive cardiomyopathy, or certain arrhythmias. •  β-Blockers can be used in combination with other antihypertensive drugs to achieve maximal blood pressure control. Labetalol can be used in hypertensive emergencies and urgencies.

Efficacy and tolerability of nebivolol in stage I-II hypertension: a pooled analysis of data from three randomized, placebo-controlled monotherapy trials.

Background: Nebivolol is a β(1)-selective β-blocker with NO-mediated vasodilatory properties, approved in the United States for the treatment of stage I-II hypertension.

Objective: The purpose of this pooled analysis was to summarize efficacy and provide a brief overview of the tolerability associated with the use of nebivolol.

Methods: PubMed was searched for randomized, double-blind, placebo-controlled, parallel-group trials of monotherapy with nebivolol for stage I-II hypertension of at least 12 weeks' duration.

The Baltimore Partnership to Educate and Achieve Control of Hypertension (The BPTEACH Trial): a randomized trial of the effect of education on improving blood pressure control in a largely African American population.

Hypertension is a major risk factor for developing cardiovascular disease and is more prevalent in African Americans compared with Caucasians. African Americans are often underrepresented in clinical trials. This study was composed of a largely urban African American cohort of hypertensive patients.

Barriers to self-management of diabetes: a qualitative study among low-income minority diabetics.

Objectives: Diabetes self-management is a key element in the overall management of diabetes. Identifying barriers to disease self-management is a critical step in achieving optimal health outcomes. Our goal was to explore patients' perceptions about barriers to self-management of diabetes that could possibly help explain poor health outcomes among minority patients.

Treatment of heart failure in African Americans--a call to action.

Advances in heart failure treatment have not necessarily translated into equity in improved outcomes for African Americans. Heart failure in African Americans is characterized by a higher prevalence, especially at younger ages; more-adverse course with more frequent hospitalizations; and higher mortality rates compared to the general population. Despite this distinct disease profile, African Americans are remarkably underrepresented in large heart failure trials.

Readmissions after unauthorized discharges in the cardiovascular setting.

Background: Patients who left against medical advice (AMA) may be at higher risk for a hospital readmission if the unauthorized discharge was premature. The objective of this study is to examine the relationship between discharges AMA from nonfederal acute care hospitals and cardiovascular disease (CVD) hospital readmissions while addressing bias due to potential confounding, selection, and hospital-level clustering.

Methods: This cross-sectional study used hospital discharge data covering the period between 2000 and 2005.

Management of high blood pressure in Blacks: an update of the International Society on Hypertension in Blacks consensus statement.

Since the first International Society on Hypertension in Blacks consensus statement on the "Management of High Blood Pressure in African American" in 2003, data from additional clinical trials have become available. We reviewed hypertension and cardiovascular disease prevention and treatment guidelines, pharmacological hypertension clinical end point trials, and blood pressure-lowering trials in blacks. Selected trials without significant black representation were considered.

Reasons for discharges against medical advice: a qualitative study.

Background: There is limited information in the literature about reasons for discharges against medical advice (DAMA) as supplied by patients and providers. Information about the reasons for DAMA is necessary for identifying workable strategies to reduce the likelihood and health consequences of DAMA. The objective of this study is to identify the reasons for DAMA based on patient and multicategory provider focus-group interviews (FGIs).

Amlodipine/Atorvastatin single-pill therapy for blood pressure and lipid goals in African Americans: influence of the metabolic syndrome and type 2 diabetes mellitus.

African Americans with diabetes +/- the metabolic syndrome are at high risk for cardiovascular disease. This subanalysis of the Clinical Utility of Caduet in Simultaneously Achieving Blood Pressure and Lipid End Points (CAPABLE) trial studied attainment of the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) and the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) goals by 8 flexibly titrated doses (5/10-10/80 mg) of amlodipine/atorvastatin single pill in 494 African Americans with hypertension and dyslipidemia, according to the presence of diabetes +/- the metabolic syndrome. In 169 diabetic patients, the metabolic syndrome was associated with poorer BP goal attainment (38.

Ethnic disparities, hospital quality, and discharges against medical advice among patients with cardiovascular disease.

Background: Nationally, cardiovascular disease is the third-ranked disease category in terms of discharges against medical advice (AMA). Disparities in discharges AMA have not been examined among patients with cardiovascular disease, nor has the moderating role of hospital quality been studied.

Methods: We examined the dual effect of race/ethnicity and hospital quality on discharges AMA by retrospectively analyzing hospital discharge data of patients who were admitted with a primary diagnosis of cardiovascular disease from 2000 through 2005.

Efficacy and safety of fixed combinations of irbesartan/hydrochlorothiazide in hypertensive women: the inclusive trial.

Objective: This post hoc analysis of the Irbesartan/Hydrochlorothiazide Blood Pressure Reductions in Diverse Patient Populations (INCLUSIVE) trial evaluated the efficacy and safety of irbesartan/hydrochlorothiazide (HCTZ) in a diverse population of hypertensive women.

Methods: INCLUSIVE was a multicenter, prospective, open-label, single-arm trial. Adult subjects had uncontrolled systolic blood pressure (SBP 140-159 mm Hg; 130-159 mm Hg for those with type 2 diabetes mellitus [T2DM]) after > or =4 weeks of antihypertensive monotherapy.

Epidemiology of atherothrombotic disease and the effectiveness and risks of antiplatelet therapy: race and ethnicity considerations.

Cardiovascular disease is the leading cause of death in the United States, accounting for approximately 60% of total mortality in 2002. There is evidence that race and ethnicity is a risk factor for atherothrombotic events. Blacks have a greater risk of complications from coronary heart disease and unstable angina, with a higher coronary heart disease death rate compared with whites.

Predictors of blood pressure response to angiotensin receptor blocker/diuretic combination therapy: a secondary analysis of the irbesartan/hydrochlorothiazide blood pressure reductions in diverse patient populations (INCLUSIVE) study.

The secondary analysis of the Irbesartan/Hydrochlorothiazide Blood Pressure Reductions in Diverse Patient Populations (INCLUSIVE) clinical trial investigated whether baseline demographic and clinical variables are predictive of different degrees of blood pressure reduction following an angiotensin II receptor blocker/diuretic treatment regimen. Irbesartan/hydrochlorothiazide and other angiotensin receptor blocker combinations with a diuretic have been shown to be effective in reducing systolic blood pressure in a diverse patient population previously uncontrolled on monotherapy. Ordinary least squares regression analysis was performed on the intent-to-treat population of the INCLUSIVE study to identify variables predictive of variations in blood pressure changes in response to irbesartan/hydrochlorothiazide combination therapy.

Efficacy and safety of fixed combinations of irbesartan/hydrochlorothiazide in older vs younger patients with hypertension uncontrolled with monotherapy.

Subgroup analysis of the Irbesartan/Hydrochlorothiazide Blood Pressure Reductions in Diverse Patient Populations (INCLUSIVE) trial evaluated the efficacy and safety of irbesartan/hydrochlorothiazide (HCTZ) fixed combinations in patients aged 65 years or older with uncontrolled systolic blood pressure (SBP) after >or= 4 weeks of antihypertensive monotherapy. The INCLUSIVE trial was a prospective, open-label, single-arm trial carried out in 119 sites. Of 844 patients completing placebo treatment, 212 were aged 65 years or older.

Improved attainment of blood pressure and cholesterol goals using single-pill amlodipine/atorvastatin in African Americans: the CAPABLE trial.

Objective: To investigate the efficacy and safety of single-pill amlodipine/atorvastatin therapy for the simultaneous treatment of hypertension (HTN) and dyslipidemia in African Americans.

Patients And Methods: Conducted between July 19, 2004, and August 9, 2005, the Clinical Utility of Caduet in Simultaneously Achieving Blood Pressure and Lipid End Points trial was a 20-week, open-label, noncomparative, multicenter trial of the efficacy and safety of single-pill amlodipine/atorvastatin in controlling elevated blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) in African Americans with concomitant HTN and dyslipidemia and either no additional risk factors, 1 or more cardiovascular risk factors, or coronary heart disease or a risk equivalent. Eight dosage strengths of single-pill amlodipine/atorvastatin were flexibly titrated.

The efficacy and tolerability of nebivolol in hypertensive African American patients.

Hypertensive African Americans often respond poorly to beta-blocker monotherapy, compared with whites. There is evidence, however, that suggests that this response may be different if beta-blockers with vasodilating effects are used. This 12-week, multi-center, double-blind, randomized placebo-controlled study assessed the antihypertensive efficacy and safety of nebivolol, a cardioselective, vasodilating beta1-blocker, at doses of 2.