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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 (-5.0 mm Hg; 95% confidence interval, -8.0 to -2.0) and AZL-M 80 mg and placebo (-7.8 mm Hg; 95% confidence interval, -10.7 to -4.9) were significant (P≤.001 vs placebo for both comparisons). Changes in the clinic BPs were similar to the ambulatory BP results. Incidence rates of adverse events were comparable among the treatment groups, including those of a serious nature. In African-American patients with hypertension, AZL-M significantly reduced ambulatory and clinic BPs in a dose-dependent manner and was well tolerated.

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. Results We prospectively define seven alternate designs consisting of various combinations of arm dropping, adaptive randomization, and early stopping and describe how these designs will be compared to the original ALLHAT design. We identify the one particular design that would have been executed, which incorporates early stopping and information-based adaptive randomization. Limitations While the simulation realistically emulates patient enrollment, interim analyses, and adaptive changes to design, it cannot incorporate key features like the involvement of data monitoring committee in making decisions about adaptive changes. Conclusion This article describes our analytic approach for RE-ADAPT. The next stage of the project is to conduct the re-execution analyses using the seven prespecified designs and the original ALLHAT data.

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. The authors assessed the likelihood of reaching goal below predefined systolic blood pressure (SBP) and diastolic blood pressure (DBP) thresholds as well as the absolute reduction in SBP and DBP, controlling for diabetes, smoking, baseline hypertension, and demographics. The intervention group was more likely to have ever reached treatment goal at 12-month follow-up (odds ratio, 1.72; P=.11). At 18-month follow-up, the Maryland Cardiovascular Disease Promotion Program group had a statistically significant larger drop in SBP (-4.82 mm Hg, P

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. The goal of the program is to foster community collaboration to raise awareness of the need to improve health in the community and to identify and connect patients to existing resources and services that can help. A qualitative evaluation of the Baltimore CHP was conducted through focus group and key informant interviews with members of the CHAT and CHP. Results suggest that the CHP program has enhanced patient-provider relationships, brought together a wealth of resources, and made people more aware of health information. The CHP facilitated providers’ ability to help patients find resources and empowered patients in the community to better manage their health conditions. In parallel, physicians requested additional culturally sensitive resources on medical conditions that addressed the health literacy of their diverse patients. Through stakeholder engagement, many more communities beyond Baltimore can become better networked to help patients navigate the health care system and improve their health.

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. • β-Blockers may be useful in patients having hyperkinetic circulation (palpitations, tachycardia, hypertension, and anxiety), migraine headache, and essential tremor. • β-Blockers are highly heterogeneous with respect to various pharmacologic effects: degree of intrinsic sympathomimetic activity, membrane-stabilizing activity, β(1) selectivity, α(1) -adrenergic-blocking effect, tissue solubility, routes of systemic elimination, potencies and duration of action, and specific effects may be important in the selection of a drug for clinical use. • β-Blocker usage to reduce perioperative ischemia and cardiovascular complications may not benefit as many patients as was once hoped and may actually cause harm in some individuals. Currently the best evidence supports β-blocker use in two patient groups: patients undergoing vascular surgery with known ischemic heart disease or multiple risk factors for it and for patients already receiving β-blockers for known cardiovascular conditions.

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. This was a prospective, 4-arm, randomized controlled trial designed to evaluate the comparative effectiveness of both physician and patient education (PPE), patient education only (PAE), and physician education only (PHE) vs usual care (UC). Hypertension specialists gave a series of didactic lectures to the physicians, while a nurse educator performed the patient education. The mean adjusted difference in systolic blood pressure (SBP) from baseline in the PPE group was an average reduction of 12 mm Hg (95% confidence interval [CI], -4.5 to -19.4) at 6-months, followed by average reductions of 4.6 mm Hg (6.9 to -16.12) in the PAE group, 4.1 mm Hg (3.4 to -11.7) in the PHE group, and 2.6 mm Hg (3 to -8.2) in the UC group. The PPE group achieved a significantly better reduction in SBP compared with the UC group. Additional research should be conducted to evaluate whether the use of certified hypertension educators in collaboration with physicians will result in a similar blood pressure reduction.

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. This paper reviews the unique course of heart failure in African Americans and discusses treatment in the context of clinical trial evidence. African Americans with heart failure may respond differently to some standard therapies compared to whites, but low levels of enrollment of AAs in large clinical trials preclude valid conclusions in certain cases. An important exception is the African American Heart Failure Trial (AHeFT), a well-designed, prospective, randomized, placebo-controlled, double-blind study, that added a combination of fixed-dose isosorbide dinitrate/hydralazine (ISDN/ HYD) to standard therapy and showed a 43% improvement in survival and a 33% reduction in first hospitalizations. Despite compelling evidence from AHeFT, post hoc secondary analyses, and recommendations from current practice guidelines, ISDN/HYD remains underutilized in African Americans with heart failure. In this paper, we put forth a call to action for racial equity in clinical research and treatment in African Americans with heart failure.

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. In this update, blacks with hypertension are divided into 2 risk strata, primary prevention, where elevated blood pressure without target organ damage, preclinical cardiovascular disease, or overt cardiovascular disease for whom blood pressure consistently 15/10 mm Hg above target, 2-drug therapy is recommended, with either a calcium channel blocker plus a renin-angiotensin system blocker or, alternatively, in edematous and/or volume-overload states, with a thiazide diuretic plus a renin-angiotensin system blocker. Effective multidrug therapeutic combinations through 4 drugs are described. Comprehensive lifestyle modifications should be initiated in blacks when blood pressure is ≥115/75 mm Hg. The updated International Society on Hypertension in Blacks consensus statement on hypertension management in blacks lowers the minimum target blood pressure level for the lowest-risk blacks, emphasizes effective multidrug regimens, and de-emphasizes monotherapy.

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). Methods Patients who discharged against medical advice between 2006 and 2008 from a large, academic medical centre along with hospital providers reporting contact with patients who left against medical advice were recruited. Three patient-only groups, one physician-only group and one nurse/social worker group were held. Focus-group interviews were transcribed, and a thematic analysis was performed to identify themes within and across groups. Participants discussed the reasons for patient DAMA and identified potential solutions. Results Eighteen patients, five physicians, six nurses and four social workers participated in the FGIs. Seven themes emerged across the separate patient, doctor, nurse/social worker FGIs of reasons why patients leave against medical advice: (1) drug addiction, (2) pain management, (3) external obligations, (4) wait time, (5) doctor's bedside manner, (6) teaching hospital setting and (7) communication. Solutions to tackle DAMA identified by participants revolved mainly around enhanced communication and provider education. Conclusions In a large, academic medical centre, the authors find some differences and many similarities across patients and providers in identifying the causes of and solutions to DAMA, many of which relate to communication.

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. The risk of ischemic stroke is 2-4 times higher among blacks compared with whites, whereas the risk of peripheral arterial disease is highest among non-Hispanic blacks. Additionally, Asian-Pacific Islander ethnicity is an independent risk factor for bleeding, even though this ethnic group receives less antithrombotic therapy compared with whites. The increased risk of events in these patient populations may have its basis in racial and ethnic differences in the pathobiology of atherosclerosis. Some racial and ethnic populations are also inadequately prescribed antiplatelet therapy despite their higher risk. Although this difference in therapy is hard to explain, it is becoming clear that factors other than socioeconomic status or clinical presentation are influencing racial differences in physician provisions of therapy. Antiplatelet therapy, including aspirin and clopidogrel, is an important component of risk reduction strategies, and there are few data to suggest racial or ethnic variations in drug efficacies. Thus, understanding and overcoming race and ethnicity-related treatment disparities should lead to significant clinical improvements in these under-served populations.

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. Participants received treatment with placebo (4-5 weeks), HCTZ 12.5 mg (2 weeks), irbesartan/HCTZ 150/12.5 mg (8 weeks), and then irbesartan/HCTZ 300/25 mg (8 weeks). From baseline to week 18 (n=184, intent-to-treat population), mean change in SBP was -23.0+/-13.3 mm Hg (P

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 primary efficacy assessment of the main trial was the percentage of patients who attained the LDL-C treatment goals of both the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure and the National Cholesterol Education Program Adult Treatment Panel III. RESULTS Of the 1170 African American patients screened, 501 were enrolled in the study and 499 received drug therapy. At end point, 236 (48.3%) of 489 patients reached both their BP and LDL-C goals (vs 4 [0.8%] of 484 at baseline); 280 (56.8%) of 493 reached BP goals (vs 7 [1.4%] of 494 at baseline); and 361 (73.7%) of 490 reached LDL-C goals (vs 138 [28.5%] of 484 at baseline). Among the 499 patients receiving drug therapy, common treatment-related adverse events were peripheral edema (17 patients [3.4%]), headache (11 [2.2%]), myalgia (11 [2.2%]), and constipation (10 [2.0%]). CONCLUSION Single-pill amlodipine/atorvastatin therapy was well tolerated and effectively targeted HTN and dyslipidemia in this population of African Americans who were at risk of cardiovascular disease.

The metabolic syndrome (MeS) is a clustering of a group of metabolic risk factors in one person that predisposes to higher risk of cardiovascular disease (CVD) and type II diabetes. The metabolic syndrome has become increasingly common in the United States. With the increase in CVD morbidity and mortality among US adult populations, particularly African Americans, it becomes urgent to monitor and control metabolic syndrome in an effort to inform effective CVD prevention programs. We sought to assess the prevalence of and predictors of MeS syndrome in an urban, high risk, predominantly African American hypertensive population.The study is part of the NHLBI U01 grant "Baltimore Partnership Programs to Reduce Cardiovascular Disparities". A sample of 150 earlier enrolled patients was selected. Risk factors for metabolic syndrome were assessed at baseline, and include risk factors of abdominal obesity (BMI = 30), high triglycerides (triglycerides = 150 mg/dL), low HDL cholesterol (HDL40 mg/dL in men, or HDL50 mg/dL in women), elevated blood pressure (BP = 130/85 mmHg), and elevated fasting glucose (blood glucose = 100 mg/dL) - per ATP III criteria. We assessed the prevalence of MeS in general and across subgroups, and predictors of MeS were assessed using logistic regression.The prevalence of MeS in this group of patients was 40%. Significant predictors of MeS include presence of diabetes (P = 0.03; OR = 3.03, 95% CI: 1.07-8.54), younger than 64 (P = 0.04; OR = 2.38, 95% CI: 1.02-5.56), and female gender (P = 0.02; OR = 2.63; OR = 1.18-5.88). The effect of self-perceived health status remain marginally significant (P = 0.13).In this patient sample, the prevalence of MeS is higher than estimates based on the US general population. Our findings of factors associated with MeS are consistent with existing studies, with the exception of age factor, suggesting the impact of higher treatment rate and better medication compliance among elderly patients.

The relatively low participation of African Americans in phase III clinical trials has raised concerns about the appropriateness of generalizing study results to African American populations. If African American enrollment in clinical trials continues to be low, the society may continue to see disparities in the treatment of diseases as well as unanswered questions as to why the population fares less than others when diagnosed with certain diseases such as cancer and diabetes. Additionally, more clinical trials are needed to explicitly monitor the difference in outcomes across different populations. This article discusses the various reasons why African American patient recruitment and participation is sub-optimal; the critical role of clinical trials in therapies; recommendations by important authorities; and a new practice model (Collaborative Care Model) as an innovative strategy to augment participation rates of African Americans [and other minorities] in clinical trials.

There is overwhelming evidence that the renin-angiotensin system plays a significant role in the pathophysiology of hypertension and target organ damage. Agents that regulate the renin-angiotensin system, such as angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, and aldosterone antagonists, are not only effective antihypertensive agents but can prevent target organ damage. Although diuretics remain the agents of first choice for the treatment of hypertension in African Americans, ACE inhibitors have a clear role in the management of these patients. ACE inhibitors (usually when used with a diuretic) have been shown to reduce morbidity and mortality in a wide range of patient groups. ACE inhibitors are infrequently used in African Americans because of a belief that these agents are ineffective in this racial group; however, when adequate dosing and appropriate combinations are used, ACE inhibitor therapy provides effective blood pressure control. In particular, the addition of diuretics to ACE inhibitor therapy ameliorates the racial differences in efficacy seen when ACE inhibitors are administered as monotherapy. Although further confirmation in additional clinical trials is required, increased use of these agents in African Americans will likely result in a reduction in target organ damage.

A 2014 hypertension guideline raised goal systolic blood pressure (SBP) from 30% 0–1 health‐care visits per year) occurred in untreated black and white hypertensive patients without DM/CKD and BP ≥140/

Hypertension poses a significant morbidity and mortality problem among African Americans or blacks. A study of heart disease and stroke statistics in 2009 showed that African Americans have the highest age-adjusted prevalence of hypertension (44.4 % men and 43.9 % women) as compared to Whites (34.1 % men and 30.3 % women) and Mexican Americans (23.1 % men and 30.4 % women).

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.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.Between April 2005 and July 2007, there were 823 patients randomized into the study. In multivariate analyses, the intervention group in which only patients received education showed a trend toward achieving a significant mean reduction in HbA(1c) with 49% (P = .06) higher odds of reaching glycemic control and .12 (P = .06) greater absolute percentage point drop in HbA(1c) compared to the no education group.Although our study reports positive results, it warrants a special emphasis on the behavior of the patient. Study results bring attention to disease management programs such as peer support networks that empower the patients that shift some of the responsibility to them.

This article highlights information from a symposium held at the 1999 National Conference for Nurse Practitioners, Washington, D.C., November 11, 1999, sponsored by The Nursing Institute and supported by an unrestricted educational grant from Schwarz Pharma Inc. "Hypertension" was the first topic and was discussed by Elijah Saunders, MD, FACC, FACP. "Medical Chronobiology and Chronotherapy" was the second topic and was discussed by Michael H. Smolensky, PhD. The third topic, "The Nurse Practitioner and the Hypertensive Patient," was discussed by Helen C. Noel, ANP, PhD. Dr. Noel also served as chair of the symposium.

The safety and efficacy of captopril plus hydrochlorothiazide (HCTZ) were compared to nifedipine gastrointestinal therapeutic system (GITS) in 145 randomly assigned black patients with mild to moderate hypertension. Following a 4-week placebo lead-in, patients received captopril plus HCTZ 25/15 mg or nifedipine GITS 30 mg for up to 12 weeks. Upward dose titration was permitted at weeks 3 and 6. Mean seated systolic and diastolic blood pressures decreased 16.1 ± 13.5 mm Hg and 11.5 ± 7.4 mm Hg, respectively, with captopril plus HCTZ. Statistically similar decreases were observed with nifedipine GITS: systolic, 19.3 ± 12.2 mm Hg; diastolic, 13.8 ± 7.2 mm Hg. There were no clinically significant between-group differences in serum chemistries. Edema was reported in 20.3% of nifedipine GITS patients versus 1.4% of captopril plus HCTZ patients (p = 0.001). The two regimens were equally effective in controlling blood pressure in black patients; however, a higher incidence of edema occurred with nifedipine GITS compared to captopril plus HCTZ.

Abstract The antihypertensive effect of the angiotensin-converting enzyme inhibitor trandolapril administered in doses of 1, 2, and 4 mg/d was compared in 207 white patients and 91 black patients with mild to moderate hypertension following a double-blind, randomized, placebo-controlled, parallel study design. Trandolapril is a prodrug that is rapidly hydrolyzed to its active diacid metabolite, trandolaprilat. After 6 weeks of double-blind treatment, trandolapril lowered baseline sitting diastolic pressure in both white and black patients. A comparison of the antihypertensive response of the two populations revealed that the black patients required between two and four times the dose of trandolapril to obtain a response similar to that observed in the white patients. A dose of 1 mg/d trandolapril resulted in a 6.1 mm Hg mean decrease in baseline sitting diastolic pressure for white patients; a similar response (−6.5 mm Hg) was observed in the black patients at 4 mg/d. In contrast to the population differences in blood pressure, the decreases in angiotensin-converting enzyme activity were similar for both populations. An evaluation of trandolaprilat levels revealed that there were no racial differences in the trandolaprilat concentrations required to achieve a given degree of angiotensin-converting enzyme inhibition. Therefore, it appears that the antihypertensive response of black patients is not completely explained by a reduction in angiotensin-converting enzyme activity. The lack of response at a lower dose but increasing response at a higher dose could reflect another vasodepressor activity of trandolapril or just be evidence of reduced sensitivity of high blood pressure in blacks to angiotensin-converting enzyme inhibition.

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.To explore the use and potential benefits of Bayesian adaptive clinical trial designs in comparative effectiveness research.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.Comparative effectiveness trial of antihypertensive medications.Patient data sampled from the more than 42 000 patients enrolled in ALLHAT with publicly available data.Number of patients randomly assigned between groups, trial duration, observed numbers of events, and overall trial results and conclusions.The Bayesian adaptive approach and original design yielded similar overall trial conclusions. The Bayesian adaptive trial randomly assigned more patients to the better-performing group and would probably have ended slightly earlier.This virtual trial execution required limited resampling of ALLHAT patients for inclusion in RE-ADAPT (REsearch in ADAptive methods for Pragmatic Trials). Involvement of a data monitoring committee and other trial logistics were not considered.In a comparative effectiveness research trial, Bayesian adaptive trial designs are a feasible approach and potentially generate earlier results and allocate more patients to better-performing groups.National Heart, Lung, and Blood Institute.

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. Design Qualitative study using focus group interviews (FGIs). Participants A convenience sample of patients with a CVD-related discharge diagnosis who left AMA and providers (physicians, nurses and social workers) whose patients have left AMA. Primary and secondary outcomes To identify patients' reasons for discharges AMA as identified by patients and providers. To identify strategies to reduce discharges AMA. Approach FGIs were grouped according to patients, physicians and nurses/social workers. A content analysis was performed independently by three coauthors to identify the nature and range of the participants' viewpoints on the reasons for discharges AMA. The content analysis involved specific categories of reasons as motivated by the Health Belief Model as well as reasons (ie, themes) that emerged from the interview data. Results 9 patients, 10 physicians and 23 nurses/social workers were recruited for the FGIs. Patients and providers reported the same three reasons for discharges AMA: (1) patient's preference for their own doctor, (2) long wait time and (3) factors outside the hospital. Patients identified an unmet expectation to be involved in setting the treatment plan as a reason to leave AMA. Participants identified improved communication as a solution for reducing discharges AMA. Conclusions Patients wanted more involvement in their care, exhibited a strong preference for their own primary physician, felt that they spent a long time waiting in the hospital and were motivated to leave AMA by factors outside the hospital. Providers identified similar reasons except the patients' desire for involvement. Additional research is needed to determine the applicability of results in broader patient and provider populations., Article summary Article focus Prior studies identifying reasons for discharges AMA have not focused on individuals with CVD while reasons may differ in this population compared with a general inpatient sample or to individuals with a history of substance abuse or mental illness. The study identified patients' reasons for discharge AMA following a hospitalisation due to CVD. Reasons were provided by patients who left AMA and by providers (physicians, nurses and social workers) whose patients have left AMA. Key messages Reasons for leaving AMA included: (1) patients' preference for their own doctor, (2) long wait time and (3) factors outside the hospital. Patients and providers were mostly aligned in identifying patients' reasons for leaving AMA; however, providers did not identify one reason identified by patients: patients' unmet desire to be more involved in their care. The study highlighted the importance of considering patient and provider perspectives when identifying patients' reasons for leaving AMA, some of which can be addressed via improved patient–provider communication during the hospital stay. Strengths and limitations of this study Strengths of the study included: (1) a focus on a major disease group, that is, responsible for the largest number of discharges AMA among major disease groups; (2) identified care seeking attitudes and motivations that are nearly impossible to identify without direct interviews; (3) included the perspectives of the stakeholders that would need to be involved in any hospital-based intervention targeting discharges AMA, namely patients, physicians, nurses and social workers; (4) focus group sessions were conducted separately for patients, physicians and nurses/social workers in order to facilitate a candid discussion regarding the reasons for patients to leave AMA. Limitations of the study included: (1) low response rate for patient focus groups; (2) patients who did not participate in the FGIs may have identified additional reasons for a discharge AMA that were not captured in this study; (3) did not recruit homeless individuals, who constitute a subpopulation of individuals who leave AMA.

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. In the fourth arm, neither patients nor their physicians received any education. Patients with uncontrolled diabetes were enrolled in the study. The outcome was the changes in the score of patients on the diabetes knowledge test. The knowledge test was administered at the time of enrollment and every six months thereafter. The study showed that a total of 622 (75%) patients took the diabetes knowledge test. The mean diabetes knowledge test score increased over time for both insulin and non-insulin users. The mean diabetes knowledge score in patients with patient education only was 11 points higher compared to those in the group of patients and their physicians without education (P=.0104). The study indicated that patients who are exposed to the educational program end up with better knowledge on all counts, than patients who just go through the health care system in the course of usual care for diabetes.

Background: Approximately one percent of inpatient discharges are against medical advice (AMA) and national data show that diseases of the circulatory system rank third in terms of discharges AMA. Cardiovascular disease (CVD) patients are at risk of the consequences of discharges AMA (e.g. hospital readmission) however the reasons for discharges AMA in a CVD population are not known. This qualitative study aimed to identify reasons for discharges AMA among patients with a CVD admission, and from patient and provider perspectives. Methods: Healthcare providers (nurses, social workers, and physicians) and CVD patients were recruited to participate in focus groups interviews (FGIs) to discuss why CVD patients admitted at three urban hospitals discharge AMA. All FGIs took place between April 2009 and July 2009 in Maryland. Patient and provider groups were held separately in order to minimize incentives to withhold information about the reasons for discharges AMA. Thematic analysis identified themes separately for the patient groups, the physician groups, and the combined nurses and social workers group, for a total of 3 groups. Results: Nine (78% male; 67% African American; mean age=56 yrs) patients, 10 physicians (80% male) and 23 nurses/social workers (9% male) were placed in scheduled FGIs. Seven FGIs were held: 2 patient-only groups, 2 physician-only groups, and 3 nurse/social worker groups. A theme identified across all 3 groups included the patients' desire to leave AMA to see their own physician/cardiologist. Another theme, identified only from the patient groups, related to patients' knowledge of their (improved) condition and a resulting confidence in their decision to leave AMA. Patients had formed expectations regarding their level of involvement in their management plan and expressed frustration when these expectations were not met. Other themes (i.e. poor communication between/among providers and patients, obligations outside the hospital, long wait time) reported across the 3 groups have been noted in previous studies and are not new. Conclusion: We find new reasons for discharges AMA among CVD patients as well as sources of potential patient disengagement from the treatment plan, not all of which were recognized by providers.

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.The purpose of this pooled analysis was to summarize efficacy and provide a brief overview of the tolerability associated with the use of nebivolol.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. This article reports pooled changes in sitting diastolic blood pressure (DBP), systolic blood pressure (SBP), and heart rate (HR) at trough; proportions of responders (patients whose end-point sitting DBP at trough was90 mm Hg or whose sitting DBP at trough had decreased from baseline by ≤10 mm Hg); and the most frequent adverse events (AEs). These data were also summarized in the subpopulation of black patients.The literature search yielded 3 similarly designed studies. In all 3 trials, a single-blind placebo run-in phase (4-6 weeks) was followed by randomization (baseline) and a 12-week double-blind treatment phase in which patients received nebivolol 1.25 to 30 or 40 mg/d or placebo. The primary efficacy measure in all 3 trials was the mean change from baseline in sitting DBP at 12 weeks, based on the intent-to-treat population. In the pooled sample, 930 (46.1%) patients were women, and the mean age was 53.6 years. Compared with placebo (n = 205), the reductions in DBP (up to 11.1 mm Hg), SBP (up to 12.4 mm Hg), and HR (up to 9.2 beats/min) were significantly greater with nebivolol (n = 1811) at the recommended dosages of 5-30/40 mg/d (all, P0.001). The most commonly reported AEs were headache (nebivolol, all dosages, 7.1%; placebo, 5.9%), fatigue (3.6% vs 1.5%, respectively), and nasopharyngitis (3.1% vs 4.4%). The efficacy and tolerability of nebivolol in black patients were similar to those observed in the total study population.Based on the pooled results from the 3 monotherapy trials reported here, nebivolol administered for 12 weeks was efficacious and generally well tolerated in patients with stage I-II hypertension.

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.Four focus groups were conducted among 31 predominately African American patients with diabetes who were enrolled in the Baltimore Cardiovascular Partnership Study, a NIH-funded multiyear prospective partnership study. The topic guide consisted of a series of open-ended questions about knowledge of current health status, medication use, continuity of care, blood glucose level and nutrition.The focus groups confirmed that previously reported barriers to self-management persisted and identified new concerns that could be associated with poor health outcomes among minority patients with diabetes. Attitudes, perceptions and behaviors surrounding diabetes and self-management of the condition did vary across individuals, however, the variation appeared to reflect the individual's knowledge and opinions rather than patient's age, sex, or culture. The primary barrier to diabetes self-management resulted from lack of knowledge of target blood glucose and blood pressure. Several participants found some of the health information to be quite confusing.Diabetes is a major public health concern and the lack of awareness of target blood glucose and blood pressure further complicates the problem. The limited health literacy seen in this study could help explain several of the barriers to self-management. The barriers to self-management identified in this qualitative study are amenable to intervention that could improve health outcomes.

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. The outcome variables captured readmissions for a CVD-related condition following an index CVD-related discharge. The covariate of interest was an indicator for a discharge AMA in the index hospitalization. The relationship between discharges AMA and 7-day, 31-day, and 180-day readmissions was examined using multivariate models with adjustment for clustering and selection bias. RESULTS The sample included 348,572 patients, of which 7001 (2%), 19,779 (6%), and 48,855 (14%) were readmitted within 7, 31, and 180 days, respectively. The percentage of patients who were readmitted (7 days; 31 days; 180 days) was higher among the AMA group versus the non-AMA group (2.2% vs. 1%, P < 0.002; 1.3% vs. 1%, P < 0.001; 1.2% vs. 1%, P = 0.02). The adjusted odds of a CVD-related readmission to the same hospital within 7 days, 31 days, and 180 days were 154% (P < 0.001), 51% (P < 0.001), and 19% (P = 0.004) higher, respectively, for patients who left AMA. Results were robust in examining readmissions to any hospital as well as corrections for observable selection bias through propensity score analysis. CONCLUSIONS A discharge AMA among patients with a discharge diagnosis for CVD during the index hospitalization was predictive of CVD-related readmissions. The strength of the association between a discharge AMA and readmission was greatest within the first week after discharge.

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 (38.5% vs 48.5% in diabetic patients without the metabolic syndrome). Among diabetic patients (+/- the metabolic syndrome) 61% to 62% reached LDL-C goal. More than 60% of patients with diabetes uncontrolled for LDL-C were maintained on suboptimal atorvastatin therapy (mean final dose: 29.9 mg vs maximum of 80 mg). Reluctance to intensify therapy to attain accepted targets in high-risk individuals suggests a degree of clinical inertia not explained by objective evidence of dose-dependent intolerance.

The purpose of the study is to evaluate the gastrointestinal risk of nonsteroidal anti-inflammatory drugs compared with cyclooxygenase-2 inhibitors in a Medicaid managed care population. Medical and prescription claims were analyzed for all Medicaid-enrollees aged 18 years and older, who received a cyclooxygenase-2 or other prescription nonsteroidal anti-inflammatory drug between January 6, 2000 and January 6, 2002, and who did not use these drugs for at least 6 months prior. A logistic model was developed of the propensity for either treatment and stratified patients by quintiles of their propensity score, adjusting for demographics, indications for nonsteroidal anti-inflammatory drugs and gastrointestinal risks. The rates of gastrointestinal event (ICD-9 codes 531-534,578) among nonsteroidal anti-inflammatory drug and cyclooxygenase-2 users were compared. The model was adjusted for drug exposure which was calculated using the medication possession ratio. Of the total sample, 73% were female, 43% were Caucasian and 29% were older than 50 years. Both the direct and the propensity adjusted model, controlling for gastroprotective agents, and medication possession ratio showed significantly different rates of gastrointestinal events in nonsteroidal anti-inflammatory drug users as compared with cyclooxygenase-2 users (odds ratio = 1.874, 95% confidence interval 1.056, 3.326) and (odds ratio = 2.088, 95% confidence interval 1.061, 4.110) respectively. A significant difference in gastrointestinal event rates was found among patients in this Medicaid population on nonsteroidal anti-inflammatory drug versus cyclooxygenase-2 inhibitors, when the gastroprotective agent use and the medication possession ratio were controlled for. Misclassification bias was accounted for by adjusting for length of drug exposure.

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.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.A total of 2619 of the 312,183 hospitalizations for cardiovascular disease (.8%) resulted in a discharge AMA. The sample was 50% male, 32% non-White, and an average age of 68 years of age. Non-White race was associated with a higher probability of a discharge AMA in a high-quality hospital (adjusted odds ratio [AOR] 1.2, P.001). Non-White race/ethnicity was associated with a lower probability of a discharge AMA in a low-quality hospital (AOR .8, P = .01). A discharge AMA was less likely at a high-quality hospital (AOR .7, P.001), regardless of race/ethnicity. The modifying effect of hospital quality is more apparent at the highest levels of hospital quality.Hospital quality is negatively correlated with discharges AMA and moderates the relationship between race/ethnicity and discharges AMA.

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.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]) afteror =4 weeks of antihypertensive monotherapy. Treatment was sequential: placebo (4-5 weeks), HCTZ 12.5 mg (2 weeks), irbesartan/HCTZ 150/12.5 mg (8 weeks), and irbesartan/HCTZ 300/25 mg (8 weeks). Mean changes from baseline to treatment end in SBP and diastolic blood pressure (DBP), BP goal attainment, and safety were assessed.Treatment with irbesartan/HCTZ was associated with significant mean reductions in BP (intent-to-treat population, n = 370; SBP/DBP: -22.9/-10.3 +/- 14.7/8.8 mm Hg). Improvements in SBP were observed in all subgroups (p0.001): Caucasian (n = 207) -23.5 +/- 13.5 mm Hg; African American (n = 93) -21.0 +/- 17.2 mm Hg; Hispanics/Latino (n = 66) -23.6 +/- 14.3 mm Hg; age65 years (n = 281) -22.5 +/- 14.7 mm Hg; ageor =65 years (n = 89) -24.3 +/- 14.5 mm Hg; T2DM (n = 97) -19.0 +/- 15.1 mm Hg; and metabolic syndrome (n = 187) -22.1 +/- 14.6 mm Hg. Overall, 82% (95% confidence interval [CI] 78%-86%) of women achieved their SBP goal, 86% (95% CI 83%-90%) achieved their DBP goal, and 76% (95% CI 71%-80%) achieved their dual SBP/DBP goal. Treatments were well tolerated in all groups.Irbesartan/HCTZ treatment was effective and well tolerated in a diverse population of women whose BP was previously uncontrolled on monotherapy.

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. Higher baseline systolic blood pressure, female sex, type 2 diabetes, and statin therapy were found to be predictive of additional blood pressure lowering with this combination. The impact of higher baseline systolic blood pressure and diabetic state on changes in systolic blood pressure were diminished in female patients compared with male patients. In conclusion, a significant correlation may exist between certain clinical/demographic characteristics and the extent of the therapeutic response with irbesartan/hydrochlorothiazide treatment.

1. 1. The American College of Cardiology acknowledges the continuum of changing societal, medical and economic perspectives affecting traditional medical ethics. Primacy of patient responsibility remains paramount to the cardiovascular specialist who at the same time should participate in the development of broader societal programs. 2. 2. Medical decisions should be freely and jointly formulated by the patient and the cardiovascular specialist with appropriate sensitivity to such matters as mental competence, pertinent medical information and standards of care, sufficient time for contemplation, informed consent, patient right of refusal, physician right to refuse to provide inappropriate care and the right of patient, physician or third party payer to seek consultation or additional opinions. 3. 3. The cardiovascular specialist should make a special effort to clarify and document patient preferences regarding end-of-life treatment through some form of advance directive. 4. 4. The cardiovascular specialist bears a moral obligation to provide medical care to any patient who is HIV positive or has AIDS. 5. 5. A conflict of interest occurs when a cardiovascular specialist places personal or financial interest ahead of the welfare and health of a patient. Professional accountability should be established through local or regional peer review. 6. 6. The American College of Cardiology encourages and supports a renewed dedication to the principles of medical ethics, particularly in the field of cardiovascular disease. Cardiovascular specialists are encouraged to participate in the promulgation of medical ethics by teaching and by example, individually and with others.

Eighty-four patients with diastolic blood pressure ranging from 100-115 mm Hg were randomized into a multicenter, parallel, double-blind, placebo-controlled, dose response study with nilvadipine (6 mg, 8 mg, 10 mg tid for 28 days). The hypotensive response pattern to nilvadipine was similar with all three doses although duration of response was dose dependent. Maximal decreases in diastolic blood pressure occurred at 1 hour when assessed on days 1 and 15 (16.0, 17.4, and 15.8 mm Hg, vs 17.2, 18.7, and 17.5 mm Hg, respectively). The hypotensive effect remained significant compared to placebo for at least 4 hours after dosing. The increase in heart rate associated with the maximal hypotensive response was minimal and not clinically significant (day 1: 7.6, 5.2, and 4.0 beats/min with 6, 8, and 10 mg; day 15: 4.0, 5.1, 2.6 beats/min with 6, 8, 9, and 10 mg, respectively). Finally, a correlation between plasma drug concentrations and nilvadipine-induced hypotensive response was observed (r = 0.48). Black and white hypertensive patients had similar hypotensive responses. Plasma nilvadipine concentrations on day 15 were similar to those on day 1 suggesting no accumulation of drug with a tid regimen. The most common drug related side effect was headache; less frequently seen were dizziness, edema, palpitations, and abdominal pain. Nilvadipine was well tolerated (only three patients were discontinued due to side effects). The efficacy, lack of tachycardia, and side effect profile observed in this study suggest that nilvadipine may be an important addition to the treatment of hypertension.

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 2.5, 5, 10, 20, or 40 mg once daily in 300 African American patients with stage I or II hypertension (mean sitting diastolic blood pressure [SiDBP] > or =95 mm Hg and < or =109 mm Hg). The primary efficacy end point was the baseline-adjusted change in trough mean SiDBP. After 12 weeks, nebivolol significantly reduced least squares mean SiDBP (P< or =.004) at all doses of 5 mg and higher and sitting systolic blood pressure (P< or =.044) at all doses 10 mg and higher, compared with placebo. The drug was safe and well-tolerated, with no significant difference in the incidence of adverse events compared with placebo. Nebivolol monotherapy provides antihypertensive efficacy, with few significant adverse effects, in hypertensive African Americans.

Epidemiologic evidence indicates that African Americans are at greater risk for hypertension compared with other ethnic groups in the United States. The prevalence of hypertension is estimated to be approximately 37% for this group, compared with 20%–25% for non-Hispanic whites. Hypertension seems to follow a more malignant course in African Americans, possibly as a result of the higher prevalence of concomitant cardiovascular risk factors in this population. Compared with white persons with hypertension, these patients are at increased risk for left ventricular hypertrophy, heart failure, and end-stage renal disease. Data suggest that ethnicity may influence the response to certain types of antihypertensive medication. Additional data indicate that more aggressive use of combination therapy may improve clinical outcomes among high-risk hypertensive patients. Based on these findings, recommendations are made for the optimal clinical management of hypertension in African-American patients.

This subgroup analysis of the Irbesartan/Hydrochlorothiazide (HCTZ) Blood Pressure Reductions in Diverse Patient Populations (INCLUSIVE) trial evaluated the efficacy and safety of irbesartan/HCTZ fixed combinations in adults with uncontrolled systolic blood pressure (SBP) (140-159 mm Hg; 130-159 mm Hg for type 2 diabetes mellitus [T2DM]) after >or=4 weeks of antihypertensive monotherapy. Treatment was sequential: placebo (4-5 weeks), HCTZ 12.5 mg (2 weeks), irbesartan/HCTZ 150/12.5 mg (8 weeks), and irbesartan/HCTZ 300/25 mg (8 weeks). In the intent-to-treat analysis, mean change from baseline (end of placebo phase) off all previous therapy to Week 18 (study end) in T2DM patients (n=227) was -18.2+/-14.1 mm Hg for SBP (primary end point; p

To identify the components and impact of intervention programs aimed at reducing cardiovascular disparities.A MEDLINE literature search with key words "cardiovascular" and "African American" was conducted, and all documented interventions targeted at reducing racial disparities were selected for review. We identified the type of intervention, the populations targeted, the length of intervention, and its impact. Articles that documented scientific evidence and some case reports were reviewed.Existing studies widely document cardiovascular disparities as they pertain to structure, process, and outcomes. Other factors affecting disparities pertain to patient, physician, system, or treatment factors. Documented programs tend to focus on lifestyle risk factors and attitudes toward those risk factors. The timelines in the studies are relatively short and do not allow for recording clinical endpoints. Most of the studies do not hinge on comprehensive community support, and they lack a sustainability component.The impact of programs has been short lived, which points to the need for sustainability programs possibly through community partnerships.

Background and Aim: Cardioprotective strategies implemented to prevent ischemic events in patients at risk for cardiovascular disease have decreased morbidity and prolonged survival. In this review, we have used evidence-based medicine and number-needed-to-treat (NNT) analyses to determine which interventions are most beneficial in minimizing ischemic events and prolonging survival following coronary artery bypass graft (CABG) surgery. Methods: Therapeutic interventions available to minimize ischemic events in the post-CABG patient were analyzed using ACC/AHA Classifications and Level of Evidence Criteria. Based on these recommendations, NNT analyses were performed to determine the effectiveness of each intervention compared to the number of patients needed to be treated before a benefit was apparent. Results: The most beneficial intervention to improve mortality following CABG was the use of high tissue angiotensin-converting enzyme inhibitors, followed by statins and smoking cessation. Conclusions: NNT analyses and evidence-based medicine recommendations provide surgeons with cardioprotective strategies to improve long-term outcomes following CABG surgery.

The National Cholesterol Education Program defines the metabolic syndrome as three or more of five abnormalities: waist circumference of40 in (102 cm) for men or35 in (88 cm) for women, triglyceride level ofor =150 mg/dL, high-density lipoprotein cholesterol of40 mg/dL in men or50 mg/dL in women, blood pressure ofor =130 oror =85 mm Hg, and fasting glucose ofor =110 mg/dL. It is related to insulin resistance, but the two terms are not synonymous. Both are associated strongly with obesity. The metabolic syndrome is important as an indicator of increased risk of cardiovascular disease (CVD) in patients with and without clinical CVD. The CVD risk of the metabolic syndrome is greater than that conferred by any single CVD risk factor. Since risk factors tend to cluster, if one component of the metabolic syndrome is present, one should assess for other risk factors. The metabolic syndrome is also predictive of new-onset type 2 diabetes. Early diagnosis provides justification for measures that can improve components of the syndrome and reduce CVD risk. The management strategy for metabolic syndrome focuses on overall CVD risk rather than single risk factors; effective therapy includes priority for weight reduction and increased physical activity. Pharmacotherapy is typically needed for control of high blood pressure, hypercoagulability, and increased levels of blood glucose and triglycerides.

This multicenter, prospective, open-label, single-arm study determined the efficacy and safety of irbesartan/hydrochlorothiazide (HCTZ) fixed combinations in patients (n=1005), aged 18 years and older, with uncontrolled systolic blood pressure (SBP) of 140-159 mm Hg (130-159 mm Hg for type 2 diabetes mellitus) after at least 4 weeks of antihypertensive monotherapy. Treatment was sequential: placebo (4-5 weeks), HCTZ 12.5 mg (2 weeks), irbesartan/HCTZ 150/12.5 mg (8 weeks), and irbesartan/HCTZ 300/25 mg (8 weeks). Enrolled patients (n=844) were aged 57.3+/-11.2 years; 52% were women, 23% were African American, and 14% were Hispanic. Thirty percent had type 2 diabetes mellitus, 46% had metabolic syndrome, and baseline blood pressure was 154.0+/-10.3/91.3+/-8.8 mm Hg. The mean change in SBP from placebo end to the primary end point, Week 18 (intent-to-treat population, n=736) was -21.5+/-14.3 mm Hg (p0.001). The mean change in diastolic blood pressure (DBP) was -10.4+/-8.7 mm Hg (p0.001). The mean Week 18 SBP/DBP was 132.9+/-13.8/81.1+/-9.7 mm Hg. Overall, 77% (95% confidence interval, 74%-80%) of patients achieved SBP goal (140 mm Hg;130 mm Hg for type 2 diabetes mellitus); 83% (95% confidence interval, 80%-86%) achieved DBP goal (90 mm Hg;80 mm Hg for type 2 diabetes mellitus); and 69% (95% confidence interval, 66%-72%) achieved dual SBP/DBP goal. Treatments were well tolerated. This irbesartan/HCTZ treatment regimen achieved SBP goals in more than 75% of patients uncontrolled on monotherapy.

OBJECTIVE: To identify patient characteristics that are associated with the incidence of thiadolidinediones (TZDs) or metformin prescnbing in Medicaid managed care plans. RESEARCH DESIGN AND METHODS: We utilized a retrospective cohort study design. Two-and-one-half years of prescription claims of Medicaid managed care organizations (MCOs) patients who were new utilizers of metformin or TZDs were analyzed using univariate, bivariate and multivariate models. Multivariate logistic regression models were built to assess the combined effect of all variables on the likelihood of incident use of TZDs or metformin. RESULTS: Claims for 3,041 patients were analyzed for the period between January 15, 2000 and June 15, 2002. African Americans and urban residents were less likely to be started on TZDs (OR = 0.678, 95% C1 = 0.830-1.206; OR = 0.579, 95% CI = 0.479-0.699, respectively). Advanced age, preexisting comorbidities and diabetes complications, and prior use of other oral diabetes drugs or insulin were predictors of increased likelihood of TZD initiation. CONCLUSIONS: Race, age, residential setting, preexisting comorbidities and diabetes complications, other oral diabetes drug use, and insulin use are statistically significant predictors of initial prescribing of TZD or metformin in a Medicaid MCO population. Findings can potentially inform the management of diabetes in managed care so as to improve outcomes.

This article provides an overview of our current understanding of the epidemiology of obesity, the metabolic syndrome, and hypertension among racial/ethnic groups. Three presentations made at the conference by the present writing group are summarized and updated with other information on ethnic groups, and recommendations developed by the writing group for programs, public policy, and research are put forward.

Before hypertension can be effectively treated in older African-American patients, the clinician must become familiar with the attitudes of this population regarding this disease. One of the major barriers to effective antihypertensive therapy is having a clinician who is not aware of potential impact that patient attitudes have on compliance with office visits and pharmacological therapy. One group of investigators did a survey of African Americans, Hispanic Americans, and non-Hispanic white adults over the age of 75 years that assessed ethnic differences in perceptions regarding the cause, prevention, and treatment of hypertension as well as associations between perceptions and the use of preventive health services (1). The survey found that African Americans felt that hypertension resulted from poor health behaviors and stress, but that it was both preventable and treatable. In contrast, non-Hispanic whites felt that hypertension is a result of various mechanistic causes and heredity; also, they felt hypertension was treatable but not preventable. Finally, Hispanic Americans were more likely to state that hypertension was the result of aging and poor health behaviors and was not susceptible to treatment.

Race has been considered an important factor in determining blood pressure response to treatment and selection of antihypertensive drug therapy. Data collected during a clinical trial that evaluated rapidity of medication up-titration with blood pressure response to monotherapy with the angiotensin-converting enzyme (ACE) inhibitor quinapril were used to characterize response in 533 black and 2046 white participants. Our objectives were to examine the influence of race and other factors on blood pressure response and to assess the degree to which nonrace factors account for apparent racial differences in response. Average systolic and diastolic blood pressure responses (baseline minus follow-up) to treatment were assessed with treatment groups combined. Crude systolic and diastolic blood pressure responses averaged 4.7 and 2.4 mm Hg less, respectively, in black compared with white participants; however, the response distributions largely overlapped. In multivariate linear regression models adjusted for study design variables and measured participant characteristics, the racial difference in systolic response was reduced by 51% to 2.3 mm Hg, and diastolic response by 21% to 1.9 mm Hg. In these models, participant characteristics, including age, gender, body size, and pretreatment blood pressure severity, significantly predicted either attenuated or enhanced blood pressure response to treatment. Our findings demonstrate that a large source of variability of blood pressure response to treatment is within, not between, racial groups, and that factors that vary at the level of the individual contribute to apparent racial differences in response to treatment.

Hypertension is one of the most frequently diagnosed chronic medical conditions in the United States and imposes a substantial financial and social burden on Americans.The aim of this study was to compare the cost of health care resources for hypertensive patients taking analgesics stratified by having controlled versus uncontrolled hypertension.This was a retrospective, database analysis of data for managed-care patients in Maryland and Washington, DC, recorded from February 1, 1999, to July 31, 2001. Hypertensive patients who were taking analgesics were stratified by their hypertension control status using a claims-based algorithm. Annualized costs and differences in annualized costs calculated for the periods before and after the initiation of analgesics were compared by patient hypertension control status.Of the 9805 patients in the study (mean [SD] age, 49.8 [12.04] years), 2523 (25.73%) were categorized as having uncontrolled hypertension. The mean total annualized costs differed significantly between the controlled and uncontrolled hypertension groups by 2568 dollars (P0.001). The annualized costs for emergency-department visits and hospitalizations for uncontrolled hypertensive patients exceeded those for controlled hypertensive patients by 9.3% and 28.0%, respectively. The differences between the postindex- and preindex-period costs for health care resources were 1972 dollars with controlled hypertension and 2961 dollars with uncontrolled hypertension (P0.001). The results of linear regression, after adjustments were made for preindex costs and other covariates, indicated that patients with uncontrolled hypertension had significantly increased billed annualized costs (P0.001).These data suggest that the costs of health care resources were significantly higher for analgesic users with uncontrolled hypertension than for analgesic users with controlled hypertension. A considerable proportion of the cost differential was directly attributable to hypertension-related treatment care.

The Metabolic Syndrome represents a specific clustering of cardiovascular risk factors. One of several recently proposed definitions encompasses 3 or more of the following 5 abnormalities: waist circumference102 cm in men or88 cm in women, serum triglyceride levelor = 150 mg/dL, high-density lipoprotein cholesterol level40 mg/dL in men or50 mg/dL in women, blood pressure (BP)or = 130/or = 85 mm Hg and serum glucoseor = 110 mg/dL. The diagnosis of Metabolic Syndrome allows early recognition of an increased risk of cardiovascular disease. African Americans have the highest coronary heart disease mortality of any ethnic group in the United States. African-American women and Hispanic men and women have the highest prevalence of the Metabolic Syndrome. This phenomenon is attributable mainly to the disproportionate occurrence of elevated BP, obesity, and diabetes in African Americans, and the high prevalence of obesity and diabetes in Hispanics. Management of the Metabolic Syndrome consists primarily of modification or reversal of the root causes and direct therapy of the risk factors. The first strategy involves weight reduction and increased physical activity, both of which can improve all components of the syndrome. The second strategy often involves drug treatment of the individual risk factors to further improve BP, lipids, and glucose thereby decreasing the risk of cardiovascular disease. This comprehensive review is provided as part of the educational activities of the African-American Lipid and Cardiovascular Council (AALCC).