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Editor's Note: Commentary based on Krakoff LR, Gillespie RL, Ferdinand KC, et al. 2014 hypertension recommendations from the eighth joint national committee panel members raise concerns for elderly black and female populations. J Am Coll Cardiol 2014;64:394-402.

Background and Objective

A report from panel members appointed to the Eight Joint National Committee (JNC-8P) recommended a major paradigm shift in blood pressure (BP) control targets, with goals of systolic blood pressure (SBP) ≤150 mm Hg for adults over 60 years of age. These new guidelines may disproportionately impact black and femaile patients. This report, therefore, sought to provide expert opinion from two writing groups outlining criticisms to the guidelines.

Methods

The state-of-the-art manuscript is divided into three sections: 1) an introduction and historical perspective on hypertension guideline reports, 2) a report from the Association of Black Cardiologists (ABC) and clinical specialist in the treatment of hypertension in black patients, and 3) a report from the Working Group on Women's Cardiovascular Health.

Results

The first section of the paper discusses the evidence that JNC-8P used to make its recommendations and describes ongoing trials in patients over 60 years of age without diabetes or chronic kidney disease (CKD). In the second section of the paper, the ABC outlines the criticisms of JNC-8P, citing that evidence used in formulating the recommendations are flawed by the inclusion of highly selected clinical trials that are not representative of broader populations and may in fact lead to under-treatment of hypertension in certain populations. Similarly, the Working Group on Women's Cardiovascular Health highlight that women with hypertension are disproportionately represented in the ≥60 age group, and therefore, the JNC-8P recommendations have the potential to worsen disparities, particularly among older African American women who are the highest risk for heart failure, atrial fibrillation, stroke, and CKD.

Conclusion

The authors conclude by strongly disagreeing with the JNC-8P 2014 recommendations to raise the threshold to initiate pharmacologic BP treatment at SBP ≤150 mm Hg for older adults without CKD or diabetes.

Commentary/Perspective

As outlined in this state of-the-art document, serious concerns have been raised regarding the validity, applicability, and potential harmful implications of the JNC-8P evidence-based guidelines for the management of hypertension in adults, especially in groups disproportionately affected by hypertension (i.e., African Americans, women, and the elderly.¹ Specifically, the two writing groups involved in this document consider the JNC-8P recommendation of increasing the SBP threshold for both diagnosis and treatment goal from 140 mm Hg to 150 mm Hg in adults 60 years of age or older as a significant point of discussion and disagreement.

According to the JNC-8P, setting a goal SBP of lower than 140 mm Hg in adults 60 years of age or older provides no additional benefit compared with a higher goal.² The supporting evidence for this recommendation comes from two trials on Asian populations,^3,4 one of which was powered to detect relatively large differences of ≥25%. This particular study was, thus, relatively underpowered to definitively determine whether strict control was superior to less stringent BP targets. Furthermore, no harm or excess adverse effects were associated with the stricter control strategy in either of these two studies. More importantly, the applicability of these results to our diverse U.S. population, especially African Americans, may not be accurate and, therefore, the validity of this recommendation is highly questionable.

In addition, among large, randomized, placebo-controlled, treatment trials, the Systolic Hypertension in the Elderly Program (SHEP)⁵ (13.9% blacks) and Hypertension in the Very Elderly Trial (HYVET)⁶ (race not specified) both included adults with isolated hypertension (average age of 72 and 84 years, respectively) and showed impressive reductions in stroke death (hazard ratio [HR] 0.71, 95% confidence interval [CI], 0.31-1.59 in SHEP and HR 0.61, 95% CI, 0.38-1.00 in HYVET), ischemic heart disease events (HR 0.80, CI 0.57-1.59 in SHEP) and cardiac death (HR 0.71, 0.42-1.19 in HYVET) with reduction of SBP to an average of 143 mm Hg in both treated cohorts. These studies, however, did not predefine tight control targets of <140 mm Hg for the active treatment group. Thus, assessment of an "ideal BP" target in these studies is elusive. The one study that did pre-specify a "tight" control goal of <130 mm Hg, the Cardio-SIS trial⁷, was not included in the JNC-8P analysis. The Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control (Cardio-Sis) showed a 27% decrease (p = 0.013) in the incidence of electrocardiographic left ventricular hypertrophy and a 50% decrease (p = 0.003) in composite cardiovascular events. Unfortunately, race was not reported in this study conducted primarily in Italy.

At least three other clinical trials that included adults 60 years of age or older have demonstrated that "tight" hypertension control significantly reduces cardiovascular outcomes. The Felodipine Event Reduction (FEVER)⁸ trial demonstrated a 27% reduction in stroke incidence while Secondary Prevention of Small Subcortical Strokes (SPS3)⁹ trial and Perindopril Protection against Recurrent Stroke Study (PROGRESS)¹⁰ showed 19% and 43% reduction in recurrent stroke, respectively. Unfortunately, the inclusion of black patients in these trials was, again, not significant, ranging from 0 to 17% (SPS3), preventing definitive conclusions in favor of tighter treatment of hypertension in the elderly black population. This data does underscore the critical need to include a diverse population in clinical research protocols, especially those with a disproportionate burden of hypertension.

In the U.S., disparities in cardiovascular disease between Caucasians and African Americans still persist.¹¹ African Americans have one of the highest rates of hypertension in the world and, in comparison to white patients, have earlier onset, increased end organ damage, worse control and more coexistent risk factors, such as obesity, type 2 diabetes, sedentary lifestyle, and psychosocial stressors.¹² Not surprisingly, this has resulted in a higher cardiovascular mortality among black patients compared to white patients for decades; this disparity gap translates into a 5.4-year shorter life expectancy, even today.¹³ This mortality gap has been attributed to hypertension more than any other risk factor.¹⁴ Therefore, adequate hypertension control in this ethnic minority remains one of the mainstays in cardiovascular disease prevention and treatment, and it is crucial to decreasing cardiovascular disparities in our nation.

Given the paucity of randomized clinical trial data in diverse ethnic minorities, especially African Americans and the elderly, there is ongoing debate about what constitutes ideal BP targets. Complex elderly patients remain a challenging group, especially when balancing benefit and harm from antihypertensive therapy. However, emerging evidence suggests that frailty does not reduce the benefits from tight BP control.¹⁵ In this patient population, as in others, clinical thinking should always direct therapy, so this should be taken into account when caring for hypertensive older adults with co-morbidities. Similarly, as mentioned previously, it is well established that hypertension disproportionately affects African Americans, who exhibit higher adverse consequences, particularly stroke, heart failure, and end-stage renal disease. Recent findings from the Coronary Artery Risk Development in Young Adults (CARDIA) study of the impact of cumulative BP on left ventricular function in early adulthood suggest that chronic exposure to higher BP, even within what is considered the normal range, appears to independently relate to left ventricular dysfunction 25 years later. This suggests that earlier hypertension treatment may be warranted.¹⁶

The general consensus among leading experts and guideline groups remains that there is insufficient data to loosen BP treatment goals from <140 mm Hg previously supported by JNC 7, consensus groups, epidemiologic data, and available clinical trial data in all stable patients 60 years of age or older. The paucity of consistent randomized clinical data in support of SBP <140 mm Hg does not equate to absence of benefit. Similarly, the absence of harm of adopting tighter BP targets encourages further investigation, especially in the most vulnerable groups. Furthermore, the potential adverse consequences of adopting looser BP targets, particularly for African Americans, women, and older adults is a serious concern as this may have unintended ill consequences.

Perhaps it is time to abandon fixed rules and/or cut offs and direct investigation and research to personalized optimal ranges. This appears to be more applicable to a conditional risk such as hypertension, which is highly dependent on age and environmental and socioeconomic factors, not just genetics. Emphasis on risk factor control remains the cornerstone of cardiovascular disease prevention for all and should undoubtedly guide our approach. Given the evidence presented and the urgent need to reduce cardiovascular health disparities between ethnic minorities, the authors of this Article Review recommend to continue BP control strategies for a goal SBP <140 mm Hg in hypertensive patients 60 years or older without diabetes and/or CKD, especially in African Americans as recommended by other major guidelines.

With the rapidly changing make-up of the U.S. population, ethnic minorities will comprise most of the patients seen in clinical practice. It is abundantly clear that ongoing and future clinical trials investigating optimal BP targets or ranges should make special efforts to recruit diverse populations reflecting the changing demographics of the U.S.

References

1. Krakoff LR, Gillespie RL, Ferdinand KC, et al. 2014 hypertension recommendations from the Eighth Joint National Committee panel members raise concerns for elderly black and female populations. J Am Coll Cardiol 2014;64:394-402.
2. James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA 2014;311:507-20.
3. Group JS. Principal results of the Japanese trial to assess optimal systolic blood pressure in elderly hypertensive patients (JATOS). Hypertens Res 2008;31:2115-27.
4. Ogihara T, Saruta T, Rakugi H, et al. Target blood pressure for treatment of isolated systolic hypertension in the elderly: valsartan in elderly isolated systolic hypertension study. Hypertension 2010;56:196-202.
5. Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension. Final results of the Systolic Hypertension in the Elderly Program (SHEP). SHEP Cooperative Research Group. JAMA 1991;265:3255-64.
6. Beckett NS, Peters R, Fletcher AE, et al. Treatment of hypertension in patients 80 years of age or older. N Engl J Med 2008;358:1887-98.
7. Verdecchia P, Staessen JA, Angeli F, et al. Usual versus tight control of systolic blood pressure in non-diabetic patients with hypertension (Cardio-Sis): an open-label randomised trial. Lancet 2009;374:525-33.
8. Liu L, Zhang Y, Liu G, et al. The Felodipine Event Reduction (FEVER) Study: a randomized long-term placebo-controlled trial in Chinese hypertensive patients. J Hypertens 2005;23:2157-72.
9. Group SPSS, Benavente OR, Coffey CS, et al. Blood-pressure targets in patients with recent lacunar stroke: the SPS3 randomised trial. Lancet 2013;382:507-15.
10. Group PC. Randomised trial of a perindopril-based blood-pressure-lowering regimen among 6,105 individuals with previous stroke or transient ischaemic attack. Lancet 2001;358:1033-41.
11. Ayanian JZ, Landon BE, Newhouse JP, Zaslavsky AM. Racial and ethnic disparities among enrollees in Medicare Advantage plans. N Engl J Med 2014;371:2288-97.
12. Egan BM, Bland VJ, Brown AL, et al. Hypertension in african americans aged 60 to 79 years: statement from the international society of hypertension in blacks. J Clin Hypertens 2015;17:252-9.
13. Harper S, MacLehose RF, Kaufman JS. Trends in the black-white life expectancy gap among US states, 1990-2009. Health Aff (Milwood) 2014;33:1375-82.
14. Centers for Disease Control and Prevention. Vital signs: avoidable deaths from heart disease, stroke, and hypertensive disease - United States, 2001-2010. MMWR Morb Mortal Wkly Rep 2013;62:721-7.
15. Warwick J, Falaschetti E, Rockwood K, et al. No evidence that frailty modifies the positive impact of antihypertensive treatment in very elderly people: an investigation of the impact of frailty upon treatment effect in the HYpertension in the Very Elderly Trial (HYVET) study, a double-blind, placebo-controlled study of antihypertensives in people with hypertension aged 80 and over. BMC Med 2015;13:78.
16. Kishi S, Teixido-Tura G, Ning H, et al. Cumulative Blood Pressure in Early Adulthood and Cardiac Dysfunction in Middle Age: The CARDIA Study. J Am Coll Cardiol 2015;65:2679-87.

Keywords: African Americans, Antihypertensive Agents, Blood Pressure, Clinical Protocols, Confidence Intervals, Coronary Vessels, Diabetes Mellitus, Type 2, Electrocardiography, Expert Testimony, Felodipine, Hypertension, Kidney Failure, Chronic, Life Expectancy, Myocardial Ischemia, Obesity, Perindopril, Renal Insufficiency, Chronic, Risk Factors, Sedentary Behavior, Socioeconomic Factors, Stroke, Ventricular Dysfunction, Left, Ventricular Function, Left, Secondary Prevention

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