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Background: Effective management of hypertension (HTN) is a priority in primary care, necessary to decrease the costs, morbidity, and mortality associated with cardiovascular disease. Strategies to support quality improvement (QI) efforts in primary care are needed to make significant improvements in population health, especially for patients who experience socioeconomic inequalities., Local Problem: To address the high rate (>50%) of uncontrolled HTN in the state of Ohio, a statewide QI project was implemented in high-volume Medicaid practices, aimed at improving blood pressure control and addressing racial disparities. The initiative expanded to include coaching QI to support efforts in primary care practices., Methods: The Model for Improvement guided development of Plan-Do-Study-Act (PDSA) cycles facilitated by QI coaching and APRN collaboration to implement key components of HTN guidelines: accurate blood pressure measurement, effective treatment, and timely follow-up., Interventions: Interventions were implemented after PDSA cycles over 18 months in two practice sites to address HTN control. Linking multiple PDSA test cycles and review of data bimonthly allowed for reflection on the impact of interventions for non-Hispanic Black patients and the overall patient population., Results: The percentage of patients with controlled HTN, repeat blood pressure measurement, and timely follow-up improved in an urban primary care practice associated with an academic medical center and in a rural federally qualified health center., Conclusions: Primary care practices can benefit from the external support of coaching when implementing QI processes to make meaningful change. APRNs are key collaborators for expanding QI efforts in primary care., Competing Interests: The authors report no conflicts of interest., (Copyright © 2022 American Association of Nurse Practitioners.)

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≤.005) for hypertension than whites and had higher rates of DM/CKD (P<.001), similar control to <140/<90 mm Hg with DM/CKD (P=.59), and lower control without DM/CKD (<140/<90 mm Hg and <150/<90 mm Hg, P≤.01). Limited awareness (<30%) and infrequent health care (>30% 0-1 health-care visits per year) occurred in untreated black and white hypertensive patients without DM/CKD and BP ≥140/<90 mm Hg. The literature suggests benefits of treated SBP <140 mm Hg in adults 60 to 79 years without DM/CKD. The International Society of Hypertension in Blacks recommends: (1) continuing efforts to achieve BP <140/<90 mm Hg in those with DM/CK, and (2) identifying hypertensive patients without DM/CKD and BP ≥140/<90 mm Hg and treat to an SBP <140 mm Hg in black adults 60-79 years., (© 2015 Wiley Periodicals, Inc.)

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<.0001) and DBP (-3.37 mm Hg, P=.01) than the control group. The clustering of patients in social networks around hypertension education has a positive impact on the management of hypertension in minority populations and may help address cardiovascular health disparities., (© 2012 Wiley Periodicals, Inc.)

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. 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 was <90 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., Results: 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, P < 0.001). 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., Conclusion: 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., (Copyright © 2011 Elsevier HS Journals, Inc. All rights reserved.)

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., (© 2011 Wiley Periodicals, Inc.)

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., (© 2011 Wiley Periodicals, Inc.)

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 <135/85 mm Hg is recommended, and secondary prevention, where elevated blood pressure with target organ damage, preclinical cardiovascular disease, and/or a history of cardiovascular disease, for whom blood pressure consistently <130/80 mm Hg is recommended. If blood pressure is ≤10 mm Hg above target levels, monotherapy with a diuretic or calcium channel blocker is preferred. When blood pressure is >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.

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.

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. 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., Results: 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 (p < 0.001): 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; age <65 years (n = 281) -22.5 +/- 14.7 mm Hg; age > or =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., Conclusions: Irbesartan/HCTZ treatment was effective and well tolerated in a diverse population of women whose BP was previously uncontrolled on monotherapy.

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 LDLC 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.

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<.001) and diastolic BP (DBP) was -10.9+/-7.7 mm Hg (P<.001). Mean SBP/DBP at study end was 134.0+/-14.7/75.1+/-8.4 mm Hg, and SBP, DBP, and SBP/DBP goal was achieved in 73%, 96%, and 72% of patients, respectively. Irbesartan/HCTZ combination therapy allowed SBP goal attainment in 73% of patients aged 65 years or older whose hypertension was previously uncontrolled with antihypertensive monotherapy.

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.

Studies have shown that appropriate treatment of hypertension will reduce cardiovascular, renal, and cerebrovascular morbidity and mortality for all patients. Because hypertension has a multifaceted nature the disorder presents with unique features in prevalence, morbidity, and mortality among ethnic groups. Blacks, Hispanics, and Native Americans have been identified as special populations at risk for unique experiences with hypertension. Among these special populations, black Americans present unique issues in etiology, pathophysiology, severity, and response to treatment. This article reviews the varied aspects of hypertension detection, treatment, and control as they relate to the special population of black Americans.

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<0.001) and -8.7+/-8.2 mm Hg for diastolic blood pressure (p<0.001). Mean SBP/diastolic blood pressure changes in patients with the metabolic syndrome (n=345) were -21.0+/-14.3/-10.4+/-8.5 mm Hg (p<0.001). Overall, 56% (95% confidence interval, 49%-62%) of T2DM and 73% (95% confidence interval, 68%-77%) of metabolic syndrome patients achieved SBP goal (<140 mm Hg; <130 mm Hg for T2DM). Goal attainment rates were significantly higher among women with the metabolic syndrome than men. Treatments appeared to be well tolerated. Irbesartan/HCTZ fixed combinations achieved SBP goals in over half of the T2DM patients and nearly three quarters of patients with the metabolic syndrome, with SBP uncontrolled on antihypertensive monotherapy.

The IrbesartaN/hydroChlorothiazide (HCTZ) bLood pressUre reductionS In diVErse patient populations (INCLUSIVE) trial was a multicenter, prospective, open-label, single-arm study evaluating the efficacy and safety of irbesartan/HCTZ fixed combinations in patients > or = 18 years old with uncontrolled systolic blood pressure (SBP, 140-159 mmHg; 130-159 mmHg for type-2 diabetes mellitus patients) after > or = 4 weeks of antihypertensive monotherapy. This analysis focused on different racial/ethnic subgroups. Treatment was sequential: placebo (4-5 weeks), HCTZ 12.5 mg (two weeks), irbesartan/HCTZ 150/12.5 mg (eight weeks) and irbesartan/HCTZ 300/25 mg (eight weeks). Overall, 515 Caucasians, 191 African Americans and 119 Hispanics/Latinos completing placebo treatment were enrolled. Mean SBP changes from baseline (placebo treatment end) to week 18 were -21.5 +/- 13.8 mmHg for Caucasians, -20.7 +/- 16.5 mmHg for African Americans and -22.9 +/- 13.2 mmHg for Hispanics/Latinos, respectively (p<0.001 for each). Mean diastolic BP (DBP) changes were statistically significant (p<0.001) and similar among racial/ethnic subgroups. By week 18, 70% (95% CI, 66%, 74%) of Caucasian, 66% (95% CI, 59%, 74%) of African-American and 65% (95% CI, 57%, 74%) of Hispanic/Latino patients achieved dual SBP/DBP goal. Treatments appeared to be well tolerated. In conclusion, irbesartan/HCTZ treatment provided SBP/DBP goal attainment in approximately two-thirds of Caucasian, African-American and Hispanic/Latino patients with SBP uncontrolled on antihypertensive monotherapy.

Patients with established cardiovascular disease are a top priority for preventive medicine. Evidence from clinical trials supports the merits of aggressive risk reduction therapies in survivors of an acute event. Improving their cardiovascular risk factor profile prolongs survival, reduces the incidence of recurrent atherosclerotic events, and improves quality of life. Blood pressure (BP) control is an essential component of cardiovascular disease secondary prevention programs; however, many patients are not receiving adequate antihypertensive therapy to meet their BP goal. By building on the specialist's discharge antihypertensive prescription, primary care physicians are ideally positioned to assume responsibility for ensuring BP goals are achieved and maintained over the long term in patients who have survived an acute event. Current hypertension management guidelines define appropriate BP goals and incorporate clear advice on how these goals can be met. BP should be lowered slowly and carefully through lifestyle modifications and pharmacologic therapy. Antihypertensive treatment should be given according to guidelines for primary prevention, although specific antihypertensive classes are indicated for initial use in post-myocardial infarction and post-stroke patients. In many cases, BP goal attainment will require the use of combination therapy with two or more drugs from different classes. With the availability of effective and safe antihypertensive drug therapies, including fixed-dose combinations, a BP goal of <140/90 mm Hg should be achievable in most patients.

Almost one third of adults in the United States have hypertension. Prevalence data among different racial or ethnic groups indicate that a disproportionate number of African Americans have hypertension compared with non-Hispanic whites and Mexican Americans. Earlier onset of high blood pressure and greater severity of hypertension contribute to a greater burden of hypertensive target organ damage in African Americans and may be a factor in the shorter life expectancy of this population compared with white Americans. There is a clear need for improved management of hypertension in African Americans via therapeutic lifestyle interventions and pharmacotherapy. While there is some evidence that particular antihypertensive agent classes provide blood pressure-lowering advantages over others, there is no support for withholding agents of any one class. When given as monotherapy, diuretics and calcium channel blockers may be relatively more effective in lowering blood pressure in African Americans than beta blockers, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers. However, when combined with a diuretic, African Americans respond as well to these agents as other racial groups. Combination therapy using antihypertensive agents with differing modes of action provides additive antihypertensive efficacy and is well tolerated. Recent guidelines recommend combination therapy as the standard of care for patients with significant blood pressure elevation, especially those with diabetes mellitus and renal disease. These comorbidities are more common in African Americans and indicate the potential need for initial therapy with more than one agent or a combination of agents in one pill.

Background: Effectively reducing cardiovascular disease disparities requires identifying and reducing disparities in risk factors. Improved understanding of hypertension disparities is critical., Methods: Cross-sectional analysis of nationally representative samples of black and white adults 20 years and older who participated in the National Health and Nutrition Examination Survey (NHANES) 1999-2002 (white, n = 4624; black, n = 1837) and NHANES III conducted in 1988-1994 (white, n = 7121; black, n = 4709). We examined differences in hypertension prevalence, awareness, treatment, and blood pressure (BP) control among both treated and prevalent cases across the 2 periods., Results: Hypertension prevalence increased significantly from 35.8% to 41.4% among blacks and from 24.3% to 28.1% among whites and remains significantly higher among blacks. Awareness is higher among blacks (77.7% vs 70.4%; P<.001), as is treatment (68.2% vs 60.4%; P<.001). These results are driven by higher rates in black women. Blood pressure control rates among those treated have increased in both races, primarily as a result of increased BP control in black and white men (27.3% and 44.7%, respectively; P

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 (p<0.001). The mean change in diastolic blood pressure (DBP) was -10.4+/-8.7 mm Hg (p<0.001). 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.

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.

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.

Background: 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., Objective: 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., Methods: 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., Results: 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 (P < 0.001). 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 (P < 0.001). 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 (P < 0.001)., Conclusions: 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.

Background: This study evaluates the efficacy of the new dihydropyridine calcium antagonist nisoldipine extended-release (ER) compared to amlodipine on ambulatory and clinic blood pressures (BP) and heart rates in African American patients with hypertension., Methods: This prospective, double-blind trial randomized 192 patients with office diastolic BP of 95 to 114 mm Hg to receive either nisoldipine (20 to 60 mg once daily) or amlodipine (5 to 10 mg once daily) for 12 weeks in a titration-to-effect design. Using ambulatory monitoring, efficacy was assessed by measuring change from baseline in systolic and diastolic BP and heart rate during three time intervals: 24-h mean period, awake, and sleep. In addition, a subanalysis was performed to evaluate patients whose nocturnal decline in BP was elevated (nondippers) versus those whose BP declined by 10% or more (dippers)., Results: Substantial and significant mean changes from baseline in 24-h BP were observed for patients treated with nisoldipine ER (-23/-16 +/- 3/2 mm Hg) and amlodipine (-20/15 +/- 3/2 mm Hg) (between-group comparisons, P =.07 for systolic BP; P =.50 for diastolic BP). Significant and similar reductions also were observed for clinic, awake, and sleep BP. Reductions in BP in the nondippers was substantially greater than in patients with a dipper profile. Neither agent had a significant effect on ambulatory heart rate. Adverse events were mild and infrequent (headache, edema, and dizziness at rates of 4% to 15%), and similar for both agents., Conclusions: Nisoldipine ER was as effective as amlodipine in reducing 24-h BP in African-American patients with hypertension, with a similar adverse effect profile. Thus, this new therapy for delivery of a dihydropyridine calcium channel blocker is a useful antihypertensive strategy for African-American patients with hypertension.

Objectives: The purpose of this study was to evaluate the efficacy and tolerability of monotherapy with the selective aldosterone blocker eplerenone in both black and white patients with hypertension., Background: Essential hypertension and cardiovascular-renal-target organ damage is more prevalent in black than white adults in the U.S., Methods: Black (n = 348) and white (n = 203) patients with mild-to-moderate hypertension were randomized to double-blind treatment with eplerenone 50 mg, the angiotensin II receptor antagonist losartan 50 mg, or placebo once daily. Doses were increased if blood pressure remained uncontrolled. The primary end point was change in mean diastolic blood pressure (DBP) after 16 weeks of therapy., Results: Adjusted mean changes from baseline in DBP were -5.3 +/- 0.7, -10.3 +/- 0.7, and -6.9 +/- 0.6 mm Hg in the placebo, eplerenone-treated, and losartan-treated groups, respectively (mean +/- SE, p < 0.001 eplerenone vs. placebo, p < 0.001 eplerenone vs. losartan). In black patients, DBP decreased by -4.8 +/- 1.0, -10.2 +/- 0.9, and -6.0 +/- 0.9 mm Hg for the placebo, eplerenone-treated, and losartan-treated groups, respectively (mean +/- SE, p < 0.001 eplerenone vs. placebo, p < 0.001 eplerenone vs. losartan), whereas in white patients, DBP decreased by -6.4 +/- 1.0, -11.1 +/- 1.1, and -8.4 +/- 1.0 mm Hg, respectively (p = 0.001 eplerenone vs. placebo, p = 0.068 for eplerenone vs. losartan). For reduction of systolic blood pressure (SBP), eplerenone was superior to placebo and losartan in all patients combined and in black patients, and was superior to placebo in white patients. Eplerenone was as effective as losartan in reducing SBP and DBP in the high renin patient, but more effective than losartan in the low renin patient. Similarly, eplerenone was at least as effective as losartan in patients with differing baseline levels of aldosterone. Both eplerenone and losartan were well tolerated., Conclusions: The antihypertensive effect of eplerenone was equal in black and white patients and was superior to losartan in black patients.

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., (Copyright 2003 Le Jacq Communications, Inc.)

Background: African Americans with hypertension, particularly those with more severe blood pressure elevations, are generally less responsive to monotherapy from any antihypertensive class. These patients usually require treatment with drugs from > or = 2 antihypertensive classes to achieve adequate blood pressure control., Objective: The purpose of this study was to assess the antihypertensive efficacy and safety of losartan alone and in combination with hydrochlorothiazide (HCTZ) in African American adults with mild to moderate hypertension., Methods: In this 12-week, multicenter, double-blind, randomized, parallel-group, placebo-controlled study, African American patients were randomized in a 3:3:1 ratio to I of 3 treatment groups: placebo, losartan monotherapy (50 to 150 mg), or losartan plus HCTZ (50/0 to 50/12.5 to 100/25 mg). Doses were titrated at weeks 4 and 8 if sitting diastolic blood pressure (SiDBP) was > or = 90 mm Hg. Safety was assessed by determining the incidence of clinical and laboratory Adverse events and evaluating mean changes in pulse, body weight, electrocardiographic parameters, and laboratory test results., Results: A total of 440 patients were randomized-188 to placebo, 193 to losartan monotherapy, and 59 to losartan/HCTZ; 391 completed the study. At week 12, the response rate with losartan monotherapy was 45.8%, with a significant (P < or = 0.01) lowering in mean SiDBP by 6.6 mm Hg compared with placebo; the response rate with placebo was 27.2%, with a mean SiDBP reduction of 3.9 mm Hg. Sitting systolic blood pressure (SiSBP) was significantly lowered with losartan monotherapy, by 6.4 mm Hg, compared with placebo (reduction of 2.3 mm Hg). The response rate with losartan/ HCTZ was 62.7%, with reductions in SiSBP and SiDBP of 16.8 mm Hg and 10.8 mm Hg, respectively (P < or = 0.01 vs placebo and losartan monotherapy). The incidence of clinical adverse events was comparable in the 3 treatment groups., Conclusions: The results of this study suggest that in African American patients, losartan monotherapy was significantly more effective than placebo in lowering SiSBP and SiDBP. Moreover, the losartan/ HCTZ combination regimen resulted in significant and clinically meaningful additional reductions in SiSBP and SiDBP compared with losartan monotherapy or placebo. Losartan monotherapy and the losartan/HCTZ regimens were generally as well tolerated as placebo.

Background: Antihypertensive medication doses are typically increased within several weeks after initiation of therapy because of inadequate blood pressure (BP) control and/or adverse effects., Methods: We conducted a parallel-group clinical trial with 2935 subjects (53% women, n=1547) aged 21 to 75 years, with Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure VI stages 1 to 2 hypertension, recruited from 365 physician practices in the southeastern United States. Participants were randomized either to a fast (every 2 weeks; n=1727) or slow (every 6 weeks; n=1208) drug titration. Therapy with quinapril, an angiotensin-converting enzyme inhibitor, was initiated at 20 mg once daily. The dose was doubled at the next 2 clinic visits until the BP was lower than 140/90 mm Hg or a dose of 80 mg was reached., Results: Pretreatment BP averaged 152/95 mm Hg. Patients with stage 2 hypertension reported more symptoms than those with stage 1. The BP averaged 140/86, 137/84, and 134/83 mm Hg in the slow group compared with 141/88, 137/85, and 135/84 mm Hg in the fast group at the 3 respective clinic visits. The BP control rates to lower than 140/90 mm Hg at the 3 clinic visits were (slow, fast, respectively) 41.3%, 35.7% (P<.001); 54.3%, 51.5% (P=.16); and 68%, 62.3% (P=.02). In the fast group, 10.7% of participants experienced adverse events vs 10.8% in the slow group; however, 21.0% of adverse events in the fast group were "serious" vs only 12% in the slow group., Conclusion: Slower dose escalation of the angiotensin-converting enzyme inhibitor quinapril provides higher BP control rates and fewer serious adverse events than more rapid drug dose escalation.

The angiotensin-converting enzyme (ACE) inhibitor trandolapril, a non-sulfhydryl prodrug which is hydrolysed into trandolaprilat, was studied in 322 hypertensives of African-American descent using a double-blind, randomised, placebo-controlled, parallel study design. Following 6 weeks of double-blind treatment with placebo or 0.25 to 16 mg/day trandolapril, an analysis of drug effect on trough blood pressure (BP) stratified by age, gender, weight, pre-treatment plasma renin activity, and trandolaprilat concentration was performed. Two mg was the lowest effective trandolapril dose, whereas doses above 4 mg did not significantly reduce trough BP. Reduction in BP did not correlate with trough plasma trandolaprilat concentration. Pre-treatment plasma renin activity was not a reliable indicator of anti-hypertensive response, as similar reductions in BP occurred even in patients with the lowest renin levels. There were no observable differences based on age, gender or measurements of the renin-angiotensin-aldosterone axis. In conclusion, neither age, gender or plasma renin activity influenced anti-hypertensive response to angiotensin-converting enzyme inhibition in African-Americans.

The calcium antagonist amlodipine may have the potential for expanded use in children owing to its physiochemistry and pharmacokinetic profile that facilitates once-daily dosing in a liquid formulation. Its safety and efficacy have not been previously evaluated in children. A retrospective analysis of 15 pediatric bone marrow transplant patients who had amlodipine incorporated into their antihypertensive drug regimen reveals significantly lower blood pressure as compared with baseline therapy (123.5+/-2.1 mmHg and 117.2+/-2.2 mmHg, systolic blood pressure before and during amlodipine, P<0.05; 81.5+/-1.8 mmHg and 75.5+/-2.6 mmHg, diastolic blood pressure before and during amlodipine, P<0.05). Amlodipine provided improved blood pressure control in this cohort and may provide a valuable pharmacologic alternative for treatment of pediatric hypertension.

Hypertension poses serious health risks for blacks because this population presents with earlier onset and more severe forms of the disease than do nonblacks. Although diuretics are the cornerstone of antihypertensive therapy In the black population, investigators have expressed concern about adverse metabolic effects, such as hypokalemia, produced by the high doses of diuretics traditionally prescribed for blacks. Recent evidence suggests that black patients may respond equally well to the new generation of cardioselective beta-blockers and angiotensin-converting enzyme inhibitors, particularly when these agents are used together with a diuretic. A new low-dose multimechanism agent that combines the cardioselective beta-blocker bisoprolol fumarate with hydrochlorothiazide, a benzothiazine diuretic, is now available for first-line therapy for hypertension. Results of two US multicenter trials--including a subset analysis of black patients--indicate that the once-daily agent is highly effective in reducing diastolic and systolic blood pressure throughout a 24-hour period in both black and nonblack patients. The agent is well tolerated in blacks and non-blacks and has a side-effect profile comparable to placebo. Because of its efficacy and safety in black patients, bisoprolol fumarate/-hydrochlorothiazide is an appropriate therapeutic option for first-line therapy of hypertension in the black population.

Hypertension is known to occur much more frequently in blacks than in the general population, roughly 33% to 50% more frequently. In addition, severe hypertension occurs 3 to 7 times more commonly in blacks than whites and is associated with an excessive amount of target organ damage. Thus, damage to the heart, kidneys, and cerebral structures may occur as much as three to five times more frequently in blacks than the general population and is associated with a much greater mortality. Because of differences in clinical presentation, delays in entering the medical care system, and some pathophysiologic features specific for the black population, treatment becomes somewhat more challenging and should be tailored for this population. Because of economic factors often found in minority populations, inexpensive effective drugs such as diuretics and beta-blockers, which are preferred drugs according to the JNC-V, often should be given first consideration in this population. However, calcium channel blockers seem to be quite effective in this group, equal to in the white population, although they are somewhat more expensive. Angiotensin converting enzyme inhibitors, if given in proper dosage and especially with low dose diuretics, are also quite effective in this population. Tissue specific angiotensin converting enzyme inhibitors may be more effective, but further studies are needed. Studies have shown that effective treatment of the black population, in spite of the differences and the more challenging situation, can result in improved survival and reduction in morbidity and mortality from the various complications.

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.

The major differences that have been recognized between black and white hypertensives are primarily epidemiologic, with hypertension being more prevalent, having an earlier onset, and having more severe sequelae in the black population. The cause of the problem in both black and white people remains obscure, but it appears that a difference in sodium handling may contribute to the particular hemodynamic and hormonal profile of black hypertensives. Salt sensitivity, expanded plasma volume and low renin levels have been the hallmark of the black hypertensive. Complications such as stroke and left ventricular hypertrophy remain the major sequelae of this disease in blacks. Finally, a current study confirmed the improved efficacy of antihypertensive therapy in blacks to diuretics and calcium channel blockers and a somewhat lower efficacy profile to angiotensin converting enzyme inhibitors and beta blockers, although the latter classes of agents have shown better response in blacks than previously thought.

Terazosin, a new selective alpha 1-adrenergic receptor antagonist, has been found to be an effective antihypertensive agent. In a series of studies, the safety and efficacy of terazosin, alone and in combination with other antihypertensive agents, were evaluated in 1180 black patients with mild to moderate essential hypertension. Terazosin was effective in lowering blood pressure when administered alone (in dosages of 1 to 80 mg/day) and when prescribed (in dosages of 1 to 20 mg/day) in combination with other antihypertensive agents. In elderly black patients, terazosin, 1 to 10 mg daily, was as effective in lowering blood pressure as propranolol (40 to 120 mg twice daily). Changes (mean +/- SE) in sitting diastolic blood pressure from baseline were -8.1 +/- 1.4 mm Hg for terazosin and -5.0 +/- 1.5 mm Hg for propranolol. Terazosin (5 mg) combined with methyclothiazide (2.5 to 5 mg) produced a significantly greater (p less than 0.01) antihypertensive effect than that of terazosin alone. Changes (mean +/- SE) in standing diastolic blood pressure from baseline were -7.9 +/- 2.0 mm Hg for terazosin alone, -15.1 +/- 2.1 mm Hg for terazosin plus 2.5 mg of methyclothiazide, and -15.0 +/- 2.0 mm Hg for terazosin plus 5 mg of methyclothiazide. Terazosin had a favorable effect on serum lipid levels and appeared to compensate for the negative lipid effects associated with diuretics and beta-blockers when used in combination with these agents. Terazosin, alone and combined with other antihypertensive agents, was well tolerated with minimal side effects in black hypertensive patients.

A considerable disparity exists between African-Americans and US Caucasians in the incidence, severity, and management of hypertension. As a consequence, overall hypertension-related morbidity and mortality rates are at least threefold to fivefold higher in African-Americans than in Caucasians. Alarmingly high frequencies of stroke, end-stage renal disease, congestive heart failure, and left ventricular hypertrophy occur in African-Americans. To bring this crisis under control will require a renewed commitment to expanded research, improved public health measures, and more effective clinical intervention. Current hypertension control programs must be expanded and adequately funded. In addition, primary prevention of hypertension should be strongly recommended for the US population, especially African-Americans.

Although the decline in stroke and other cardiovascular morbid and mortal events has been occurring since the 1940s, the steeper decline since 1968 has been attributed to improved hypertension awareness, treatment, and control. However, in spite of this encouraging trend from the population in general, surveys from the 1970s and our more recent survey from the Maryland Hypertension Program indicate that hypertension control among blacks remains unacceptably poor, particularly in view of the high prevalence. Of special concern are black men, who have the highest prevalence of any group and the poorest control rate (see Tables 6-1 through 6-4). According to Gillum and Gillum, "High rates of non-compliance with follow-up and drug therapy seriously compromised the efforts of community-wide programs. Indeed, non-compliance with therapeutic or preventive health advice is now the major barrier to effective hypertension control in the United States." Impediments to ideal hypertension control in black communities can be divided into three categories 1. Severity of hypertension in blacks. 2. Barriers related to the medical care system, including inadequate financial resources (see also Chapter 5), inconveniently located health care facilities, long waiting times, and inaccessibility to health education, specifically as it relates to hypertension. 3. Barriers related to the social, psychosocial, and sociopolitical environment, which include problems of underemployment, unemployment, racism, and strained racial relationships. In summary, one could say that, in spite of generally improved hypertension control in the United States, the group that has the worse problems (blacks, especially males) is not benefiting as much as the general population. The strategy for treating black patients with hypertension is little different from that applied to all other patients. However, consideration must be given to the patients' lifestyle. The cultural differences in diet especially must be taken into account. Finally, economic considerations must always be an important component in managing black hypertensive patients. For a detailed discussion of treatment alternatives, see Chapter 11.

A double-blind, positively controlled, forced dose titration study comparing the efficacy and safety of atenolol, captopril, and verapamil sustained release as single agents in the treatment of black patients with mild to moderate hypertension (diastolic blood pressure, 95 to 114 mm Hg) was conducted. A total of 394 patients were randomized to one of the three therapies. Mean blood pressures during a 2- to 4-week placebo treatment period (baseline) ranged from 100.4 to 100.7 mm Hg diastolic and 151.7 to 152.5 mm Hg systolic for the three groups. Of the patients, 355 (of whom 345 had assessable data) completed the first treatment period, which consisted of therapy with either 50 mg/d of atenolol, 25 mg every 12 hours of captopril, or 240 mg/d of verapamil sustained release. During the second 4-week treatment period, which 319 patients completed (307 assessable), half of the patients had their antihypertensive medication increased and the other half continued the same dose. Goal blood pressure was defined as a supine diastolic pressure of less than 90 mm Hg or a 10-mm Hg or greater drop in supine diastolic blood pressure from pretreatment levels. Atenolol, captopril, and verapamil sustained release therapy was associated with goal blood pressure achievement during the first treatment period 55.1%, 43.8%, and 65.2% of the time, respectively, and during the second treatment period 59.6%, 57.1%, and 73.0% of the time. Side effects were minimal and comparable for all three drugs.

A multicenter, randomized double-blind clinical trial was conducted among 306 black men and women with mild to moderate hypertension to determine effects of atenolol, captopril, and verapamil SR on measures of quality of life. Patients were randomly assigned to a stable or forced-dose titration sequence. After an 8-week treatment period, the rate of withdrawal from treatment because of adverse effects was low and did not differ by drug treatment group or titration level. Patients taking verapamil SR showed a significantly greater reduction in mean blood pressures than patients treated with atenolol or captopril. Along with absence of worsening on any quality of life total scale scores examined over the treatment period, we found either improvement or no change in the total scale scores for all three treatment groups. Among both male and female patients, comparisons between drug treatment groups showed no differences in degree of change on the total scale scores. In comparisons within each treatment group, improvement in scores of male patients after 8 weeks appeared among those taking atenolol in general well-being and physical symptoms reduction; among male patients taking captopril in general well-being, physical symptoms, and sexual performance; and among male patients receiving verapamil SR in scores in irritability, sleep, and the Digit Span test. Improvement in scores among female patients taking atenolol was found in scores on general well-being, physical symptoms, and sleep; among women taking captopril on general well-being, physical symptoms, and irritability; and among women taking verapamil SR on general well-being. Patients in all treatment groups improved on measures of visuomotor functioning. The research shows that with the three newer generation antihypertensive medications studied, blood pressure control was achieved during the treatment period without negative effects on quality of life scales, along with findings of improvement on some measures. Given the special clinical features of hypertension in black patients, the study underlines as well the potential and utility of systematic tracking of measures of quality of life, while monitoring blood pressures in this patient population.

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.

The treatment of high blood pressure in black people is often complicated by a variety of factors. These include the tendency of black hypertensive patients to have three to five times the cardiovascular mortality of white hypertensive patients, black hypertensives' more frequent progression to end-organ damage and stroke, and socioeconomic conditions that impede access to proper health care. In addition, blacks have a unique hemodynamic profile, one that alters the efficacy of many antihypertensive drugs. In black hypertensives, for example, diuretics are more effective than they are in whites, whereas beta-blockers and angiotensin-converting enzyme (ACE) inhibitors are less effective. Although it is true that blacks are disproportionately represented in the hypertensive population--having up to seven times the prevalence of severe hypertension seen in whites--it is not true that they are relatively unresponsive to drug therapy. A number of long-term clinical trials have established that black hypertensives respond well to treatment. Specifically, blacks in stepped-care therapy achieve goal blood pressure at the same rate as their white counterparts, although the increased barriers to blood pressure control in blacks require practitioners to put increased effort into this therapy. Possibly because black hypertensives tend to have low plasma renin levels, beta-blockers and ACE inhibitors are not nearly as effective as diuretics when used as monotherapy. Diuretics, on the other hand, have established efficacy in blacks, and their selection for initial monotherapy is favored for two additional reasons. First, they present a better profile in terms of overall cost and compliance, thanks to their lower relative cost and once-a-day dosing. Second, when diuretics are combined with another antihypertensive therapy, such as an ACE inhibitor or a calcium-entry blocker, responsiveness may be further improved. This combination therapy may be especially important in black hypertensives, who exhibit a higher incidence of concurrent diseases such as left ventricular hypertrophy and congestive heart failure.

The high incidence and prevalence of hypertension in the black community in western societies led to early speculation that the black population consumed more sodium (sodium chloride) than the general population. However, numerous studies have failed to support this conclusion. It seems rather that it is the handling of sodium by the kidney (greater salt sensitivity) by many hypertensive blacks and the interaction of sodium with potassium, probably magnesium, calcium, and various transport systems at the cellular level that offer a better explanation of these observed phenomena.

The study involved 113 patients over age 50 years with mild to moderate essential hypertension, randomly assigned to treatment with enalapril (n = 54) or sustained-release verapamil (n = 59). During an eight-week titration period, doses were adjusted to achieve supine diastolic blood pressures (DBP) below 90 mmHg; patients were then given maintenance doses for eight weeks. Mean blood pressures were reduced significantly from 147.7/93.9 mmHg at baseline to 137.7/84.5 mmHg at the end of the maintenance period in the enalapril group and from 155.1/95.1 to 142.4/86.2 mmHg in the verapamil group. In the patients who completed treatment, the mean daily doses required to maintain DBP below 90 mmHg were 9.6 mg of enalapril and 244.9 mg of verapamil. There were 11 treatment failures in the enalapril group and 22 in the verapamil group: eight of the enalapril and 17 of the verapamil patients did not attain goal blood pressures and three and five were withdrawn because of side effects. It is concluded that both enalapril and sustained-release verapamil were generally effective and well tolerated in the treatment of mild to moderate hypertension in the middle-aged and older patients.

Efficacy and dosage data were analyzed for patients who received methyldopa up to 4.5 years. A prompt initial response to methyldopa was observed, and the blood pressure reduction was maintained throughout the follow-up period. Mean dosage rose modestly during this time.