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Efficacy and Safety of Firibastat, a First-in-Class Brain Aminopeptidase A Inhibitor, in Hypertensive Overweight Patients of Multiple Ethnic Origins A Phase 2, Open-Label, Multicenter, Dose-Titrating Study

Ferdinand, Keith C; Balavoine, Fabrice; Besse, Bruno; Black, Henry R; Desbrandes, Stephanie; Dittrich, Howard C; Nesbitt, Shawna D
BACKGROUND:Despite existing therapy, successful control of hypertension [HTN] in the United States is estimated at less than 50%. In Blacks, HTN occurs earlier, is more severe, controlled less often and has a higher morbidity and mortality than in Whites. Blacks are also less responsive to monotherapy with angiotensin-I converting enzyme [ACE] inhibitors or angiotensin-II receptor type 1 blockers [ARBs]. Obesity, higher salt-sensitivity and low plasma renin activity are possible reasons of this poor blood pressure [BP] control, especially in Blacks. The aim of the study was to assess efficacy and safety of firibastat, a first-in-class aminopeptidase A inhibitor preventing conversion of brain angiotensin-II into angiotensin-III, in BP lowering in a high-risk diverse hypertensive population. METHODS:256 overweight or obese hypertensive patients, including 54% black and Hispanic individuals, were enrolled in a multicenter, open-label, phase II study. After a 2-week wash-out period, subjects received firibastat for 8 weeks (250 mg b.i.d. orally for 2 weeks, then 500 mg b.i.d. if automated office blood pressure [AOBP] >140/90 mmHg; hydrochlorothiazide 25 mg q.d was added after 1 month if AOPB ≥160/110 mmHg). The primary endpoint was change from baseline in systolic AOBP after 8 weeks of treatment, and secondary endpoints include diastolic AOBP, 24-hour mean ambulatory BP and safety. RESULTS:Firibastat lowered systolic AOBP by 9.5 mmHg (p <0.0001) and diastolic AOBP by 4.2 mmHg (p <0.0001). 85% of the subjects did not receive hydrochlorothiazide and were treated with firibastat alone. Significant BP reduction was found across all sub-groups regardless age, sex, body mass index or race. Systolic AOBP decreased by 10.2 mmHg (p <0.0001) in obese patients, by 10.5 mmHg (p <0.0001) in Blacks, and 8.9 mmHg (p <0.0001) in Non-Blacks. Most frequent adverse events were headaches (4%) and skin reactions (3%). No angioedema was reported. No change in potassium, sodium and creatinine blood level were observed. CONCLUSIONS:Our results demonstrate the efficacy of firibastat in lowering BP in a high-risk diverse population where monotherapy with ACE inhibitors or ARBs may be less effective and support the strategy to further investigate firibastat in subjects with difficult-to-treat or potentially resistant HTN. CLINICAL TRIAL REGISTRATION/BACKGROUND:URL: https://www.clinicaltrials.gov. Unique Identifier: NCT03198793.
PMID: 31014072
ISSN: 1524-4539
CID: 3821552

Efficacy and Safety of a Novel Antihypertensive Pharmacotherapy Approach in a High-Risk Diverse Population [Meeting Abstract]

Ferdinand, Keith C.; Balavoine, Fabrice; Besse, Bruno; Black, Henry R.; Desbrandes, Stephanie; Dittrich, Howard C.; Nesbitt, Shawna D.
ISI:000453713500031
ISSN: 0009-7322
CID: 3587652

Treatment Resistant Hypertension and Outcomes based on Randomized Treatment Group in ALLHAT

Bangalore, Sripal; Davis, Barry R; Cushman, William C; Pressel, Sara L; Muntner, Paul M; Calhoun, David A; Kostis, John B; Whelton, Paul K; Probstfield, Jeffrey L; Rahman, Mahboob; Black, Henry R
BACKGROUND: Although hypertension guidelines define treatment resistant hypertension as blood pressure uncontrolled by >/=3 antihypertensive medications, including a diuretic, it is unknown whether patient prognosis differs when a diuretic is included. METHODS: Participants in the Antihypertensive and Lipid-Lowering to Prevent Heart Attack Trial were randomly assigned to first-step therapy with chlorthalidone, amlodipine, or lisinopril. At a Year 2 follow-up visit, those with average BP>/=140 mmHg systolic or >/=90 mmHg diastolic on >/=3 antihypertensive medications, or BP<140/90 mmHg on >/=4 antihypertensive medications, were identified as having apparent treatment resistant hypertension. The prevalence of treatment resistant hypertension and its association with ALLHAT primary (combined fatal coronary heart disease or nonfatal myocardial infarction) and secondary (all-cause mortality, stroke, heart failure, combined coronary heart disease, and combined cardiovascular disease) outcomes were identified for each treatment group. RESULTS: Of participants assigned to chlorthalidone, amlodipine and lisinopril, 9.6%, 11.4% and 19.7%, respectively, had treatment resistant hypertension. During mean follow-up of 2.9 years, primary outcome incidence was similar for those assigned to chlorthalidone compared to amlodipine or lisinopril (amlodipine vs. chlorthalidone adjusted HR=0.86; 95% CI 0.53-1.39; P=0.53; lisinopril vs. chlorthalidone adjusted HR=1.06; 95% CI 0.70-1.60; P=0.78). Secondary outcome risks were similar for most comparisons except coronary revascularization, which was higher with amlodipine than with chlorthalidone (HR=1.86; 95% CI 1.11-3.11; P=0.02). An as-treated analysis based on diuretic use produced similar results. CONCLUSIONS: In this study, which titrated medications to a goal, participants assigned to chlorthalidone were less likely to develop treatment resistant hypertension. However, prognoses in those with treatment resistant hypertension were similar across treatment groups. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov, NCT00000542.
PMCID:5362319
PMID: 27984005
ISSN: 1555-7162
CID: 2363712

Clinical Use of Pulse Wave Analysis: Proceedings From a Symposium Sponsored by North American Artery

Townsend, Raymond R; Black, Henry R; Chirinos, Julio A; Feig, Peter U; Ferdinand, Keith C; Germain, Michael; Rosendorff, Clive; Steigerwalt, Susan P; Stepanek, Jan A
The use of pulse wave analysis may guide the provider in making choices about blood pressure treatment in prehypertensive or hypertensive patients. However, there is little clinical guidance on how to interpret and use pulse wave analysis data in the management of these patients. A panel of clinical researchers and clinicians who study and clinically use pulse wave analysis was assembled to discuss strategies for using pulse wave analysis in the clinical encounter. This manuscript presents an approach to the clinical application of pulse waveform analysis, how to interpret central pressure waveforms, and how to use existing knowledge about the pharmacodynamic effect of antihypertensive drug classes in combination with brachial and central pressure profiles in clinical practice. The discussion was supplemented by case-based examples provided by panel members, which the authors hope will provoke discussion on how to understand and incorporate pulse wave analysis into clinical practice.
PMID: 26010834
ISSN: 1751-7176
CID: 1663632

Treatment of hypertension in patients with coronary artery disease: a scientific statement from the american heart association, american college of cardiology, and american society of hypertension

Rosendorff, Clive; Lackland, Daniel T; Allison, Matthew; Aronow, Wilbert S; Black, Henry R; Blumenthal, Roger S; Cannon, Christopher P; de Lemos, James A; Elliott, William J; Findeiss, Laura; Gersh, Bernard J; Gore, Joel M; Levy, Daniel; Long, Janet B; O'Connor, Christopher M; O'Gara, Patrick T; Ogedegbe, Gbenga; Oparil, Suzanne; White, William B
PMID: 25828847
ISSN: 1524-4563
CID: 1645422

Treatment of hypertension in patients with coronary artery disease: A scientific statement from the American Heart Association, American College of Cardiology, and American Society of Hypertension

Rosendorff, Clive; Lackland, Daniel T; Allison, Matthew; Aronow, Wilbert S; Black, Henry R; Blumenthal, Roger S; Cannon, Christopher P; de Lemos, James A; Elliott, William J; Findeiss, Laura; Gersh, Bernard J; Gore, Joel M; Levy, Daniel; Long, Janet B; O'Connor, Christopher M; O'Gara, Patrick T; Ogedegbe, Olugbenga; Oparil, Suzanne; White, William B
PMID: 25840695
ISSN: 1878-7436
CID: 3035452

Treatment of Hypertension in Patients With Coronary Artery Disease: A Scientific Statement from the American Heart Association, American College of Cardiology, and American Society of Hypertension

Rosendorff, Clive; Lackland, Daniel T; Allison, Matthew; Aronow, Wilbert S; Black, Henry R; Blumenthal, Roger S; Cannon, Christopher P; de Lemos, James A; Elliott, William J; Findeiss, Laura; Gersh, Bernard J; Gore, Joel M; Levy, Daniel; Long, Janet B; O'Connor, Christopher M; O'Gara, Patrick T; Ogedegbe, Olugbenga; Oparil, Suzanne; White, William B
PMID: 25840655
ISSN: 1558-3597
CID: 1598732

Treatment of hypertension in patients with coronary artery disease: a scientific statement from the american heart association, american college of cardiology, and american society of hypertension

Rosendorff, Clive; Lackland, Daniel T; Allison, Matthew; Aronow, Wilbert S; Black, Henry R; Blumenthal, Roger S; Cannon, Christopher P; de Lemos, James A; Elliott, William J; Findeiss, Laura; Gersh, Bernard J; Gore, Joel M; Levy, Daniel; Long, Janet B; O'Connor, Christopher M; O'Gara, Patrick T; Ogedegbe, Gbenga; Oparil, Suzanne; White, William B
PMID: 25829340
ISSN: 1524-4539
CID: 1645432

Lack of blood pressure difference by race in professional American football players

Tucker, Andrew M; Lincoln, Andrew E; Vogel, Robert A; Black, Henry R; Dunn, Reginald E; Wilson, Peter W F; Pellman, Elliot J
Previous findings suggest that professional American football players have higher blood pressures (BP) and a higher prevalence of pre-hypertension and hypertension than the general population. We sought to determine whether race is associated with differences in BP and prevalence of pre-hypertension and hypertension among a large sample of professional football players. BP was measured at 2009 team mini-camps for 1484 black (n = 1007) and white (n = 477) players from 27 National Football League (NFL) teams. Players were categorized into three position groups based on body mass index (BMI). There was no racial difference in mean systolic or diastolic BP in any of the three position groups. There were no racial differences in prevalence of hypertension (99 [9.8%] black players vs. 39 [8.2%] white players; P = .353) or pre-hypertension (557 [55.3%] black players vs. 264 [55.3%] white players; P = 1.0). Contrary to findings in the general population, BP and prevalence of pre-hypertension/hypertension did not vary with race in a large population of active NFL players.
PMID: 25979411
ISSN: 1878-7436
CID: 1643642

Treatment: special conditions: resistant hypertension

Black, Henry R
PMID: 25641108
ISSN: 1878-7436
CID: 1509562