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Divergent Results Using Clinic and Ambulatory Blood Pressures: Report of a Darusentan-Resistant Hypertension Trial

Patients with resistant hypertension are at increased risk for cardiovascular events. The addition of new treatments to existing therapies will help achieve blood pressure (BP) goals in more resistant hypertension patients. In the current trial, 849 patients with resistant hypertension receiving ≥3... Full description

Journal Title: Hypertension (Dallas Tex. 1979), 2010-11, Vol.56 (5), p.824-830
Main Author: Bakris, George L
Other Authors: Lindholm, Lars H , Black, Henry R , Krum, Henry , Linas, Stuart , Linseman, Jennifer V , Arterburn, Sarah , Sager, Philip , Weber, Michael
Format: Electronic Article Electronic Article
Language: English
Subjects:
Publisher: Hagerstown, MD: American Heart Association, Inc
ID: ISSN: 0194-911X
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recordid: cdi_swepub_primary_oai_DiVA_org_umu_41553
title: Divergent Results Using Clinic and Ambulatory Blood Pressures: Report of a Darusentan-Resistant Hypertension Trial
format: Article
creator:
  • Bakris, George L
  • Lindholm, Lars H
  • Black, Henry R
  • Krum, Henry
  • Linas, Stuart
  • Linseman, Jennifer V
  • Arterburn, Sarah
  • Sager, Philip
  • Weber, Michael
subjects:
  • Aged
  • Antihypertensive Agents - therapeutic use
  • Arterial hypertension. Arterial hypotension
  • Biological and medical sciences
  • Blood and lymphatic vessels
  • Blood Pressure - drug effects
  • Blood Pressure Monitoring, Ambulatory
  • Cardiac and Cardiovascular Systems
  • Cardiology. Vascular system
  • Clinical manifestations. Epidemiology. Investigative techniques. Etiology
  • Clinical Medicine
  • endothelin
  • endothelin antagonist
  • Endothelin Receptor Antagonists
  • Female
  • Guanfacine - therapeutic use
  • Humans
  • hypertension
  • Hypertension - drug therapy
  • Intention to Treat Analysis
  • Kardiologi
  • Klinisk medicin
  • Male
  • Medical and Health Sciences
  • Medical sciences
  • Medicin och hälsovetenskap
  • Middle Aged
  • Phenylpropionates - therapeutic use
  • Pyrimidines - therapeutic use
  • resistant hypertension
  • Treatment Outcome
ispartof: Hypertension (Dallas, Tex. 1979), 2010-11, Vol.56 (5), p.824-830
description: Patients with resistant hypertension are at increased risk for cardiovascular events. The addition of new treatments to existing therapies will help achieve blood pressure (BP) goals in more resistant hypertension patients. In the current trial, 849 patients with resistant hypertension receiving ≥3 antihypertensive drugs, including a diuretic, at optimized doses were randomized to the selective endothelin A receptor antagonist darusentan, placebo, or the central α-2 agonist guanfacine. The coprimary end points of the study were changes from baseline to week 14 in trough, sitting systolic BP, and diastolic BP measured in the clinic. Decreases from baseline to week 14 in systolic BP for darusentan (−15±14 mm Hg) were greater than for guanfacine (−12±13 mm Hg; P
language: eng
source:
identifier: ISSN: 0194-911X
fulltext: no_fulltext
issn:
  • 0194-911X
  • 1524-4563
  • 1524-4563
url: Link


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titleDivergent Results Using Clinic and Ambulatory Blood Pressures: Report of a Darusentan-Resistant Hypertension Trial
creatorBakris, George L ; Lindholm, Lars H ; Black, Henry R ; Krum, Henry ; Linas, Stuart ; Linseman, Jennifer V ; Arterburn, Sarah ; Sager, Philip ; Weber, Michael
creatorcontribBakris, George L ; Lindholm, Lars H ; Black, Henry R ; Krum, Henry ; Linas, Stuart ; Linseman, Jennifer V ; Arterburn, Sarah ; Sager, Philip ; Weber, Michael
descriptionPatients with resistant hypertension are at increased risk for cardiovascular events. The addition of new treatments to existing therapies will help achieve blood pressure (BP) goals in more resistant hypertension patients. In the current trial, 849 patients with resistant hypertension receiving ≥3 antihypertensive drugs, including a diuretic, at optimized doses were randomized to the selective endothelin A receptor antagonist darusentan, placebo, or the central α-2 agonist guanfacine. The coprimary end points of the study were changes from baseline to week 14 in trough, sitting systolic BP, and diastolic BP measured in the clinic. Decreases from baseline to week 14 in systolic BP for darusentan (−15±14 mm Hg) were greater than for guanfacine (−12±13 mm Hg; P<0.05) but not greater than placebo (−14±14 mm Hg). Darusentan, however, reduced mean 24-hour systolic BP (−9±12 mm Hg) more than placebo (−2±12 mm Hg) or guanfacine (−4±12 mm Hg) after 14 weeks of treatment (P<0.001 for each comparison). The most frequent adverse event associated with darusentan was fluid retention/edema at 28% versus 12% in each of the other groups. More patients withdrew because of adverse events on darusentan as compared with placebo or guanfacine. We conclude that darusentan provided greater reduction in systolic BP in resistant hypertension patients as assessed by ambulatory BP monitoring, in spite of not meeting its coprimary end points. The results of this trial highlight the importance of ambulatory BP monitoring in the design of hypertension clinical studies.
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subjectAged ; Antihypertensive Agents - therapeutic use ; Arterial hypertension. Arterial hypotension ; Biological and medical sciences ; Blood and lymphatic vessels ; Blood Pressure - drug effects ; Blood Pressure Monitoring, Ambulatory ; Cardiac and Cardiovascular Systems ; Cardiology. Vascular system ; Clinical manifestations. Epidemiology. Investigative techniques. Etiology ; Clinical Medicine ; endothelin ; endothelin antagonist ; Endothelin Receptor Antagonists ; Female ; Guanfacine - therapeutic use ; Humans ; hypertension ; Hypertension - drug therapy ; Intention to Treat Analysis ; Kardiologi ; Klinisk medicin ; Male ; Medical and Health Sciences ; Medical sciences ; Medicin och hälsovetenskap ; Middle Aged ; Phenylpropionates - therapeutic use ; Pyrimidines - therapeutic use ; resistant hypertension ; Treatment Outcome
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1Lindholm, Lars H
2Black, Henry R
3Krum, Henry
4Linas, Stuart
5Linseman, Jennifer V
6Arterburn, Sarah
7Sager, Philip
8Weber, Michael
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1Hypertension (Dallas, Tex. 1979)
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descriptionPatients with resistant hypertension are at increased risk for cardiovascular events. The addition of new treatments to existing therapies will help achieve blood pressure (BP) goals in more resistant hypertension patients. In the current trial, 849 patients with resistant hypertension receiving ≥3 antihypertensive drugs, including a diuretic, at optimized doses were randomized to the selective endothelin A receptor antagonist darusentan, placebo, or the central α-2 agonist guanfacine. The coprimary end points of the study were changes from baseline to week 14 in trough, sitting systolic BP, and diastolic BP measured in the clinic. Decreases from baseline to week 14 in systolic BP for darusentan (−15±14 mm Hg) were greater than for guanfacine (−12±13 mm Hg; P<0.05) but not greater than placebo (−14±14 mm Hg). Darusentan, however, reduced mean 24-hour systolic BP (−9±12 mm Hg) more than placebo (−2±12 mm Hg) or guanfacine (−4±12 mm Hg) after 14 weeks of treatment (P<0.001 for each comparison). The most frequent adverse event associated with darusentan was fluid retention/edema at 28% versus 12% in each of the other groups. More patients withdrew because of adverse events on darusentan as compared with placebo or guanfacine. We conclude that darusentan provided greater reduction in systolic BP in resistant hypertension patients as assessed by ambulatory BP monitoring, in spite of not meeting its coprimary end points. The results of this trial highlight the importance of ambulatory BP monitoring in the design of hypertension clinical studies.
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3Biological and medical sciences
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6Blood Pressure Monitoring, Ambulatory
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25Medicin och hälsovetenskap
26Middle Aged
27Phenylpropionates - therapeutic use
28Pyrimidines - therapeutic use
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titleDivergent Results Using Clinic and Ambulatory Blood Pressures: Report of a Darusentan-Resistant Hypertension Trial
authorBakris, George L ; Lindholm, Lars H ; Black, Henry R ; Krum, Henry ; Linas, Stuart ; Linseman, Jennifer V ; Arterburn, Sarah ; Sager, Philip ; Weber, Michael
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abstractPatients with resistant hypertension are at increased risk for cardiovascular events. The addition of new treatments to existing therapies will help achieve blood pressure (BP) goals in more resistant hypertension patients. In the current trial, 849 patients with resistant hypertension receiving ≥3 antihypertensive drugs, including a diuretic, at optimized doses were randomized to the selective endothelin A receptor antagonist darusentan, placebo, or the central α-2 agonist guanfacine. The coprimary end points of the study were changes from baseline to week 14 in trough, sitting systolic BP, and diastolic BP measured in the clinic. Decreases from baseline to week 14 in systolic BP for darusentan (−15±14 mm Hg) were greater than for guanfacine (−12±13 mm Hg; P<0.05) but not greater than placebo (−14±14 mm Hg). Darusentan, however, reduced mean 24-hour systolic BP (−9±12 mm Hg) more than placebo (−2±12 mm Hg) or guanfacine (−4±12 mm Hg) after 14 weeks of treatment (P<0.001 for each comparison). The most frequent adverse event associated with darusentan was fluid retention/edema at 28% versus 12% in each of the other groups. More patients withdrew because of adverse events on darusentan as compared with placebo or guanfacine. We conclude that darusentan provided greater reduction in systolic BP in resistant hypertension patients as assessed by ambulatory BP monitoring, in spite of not meeting its coprimary end points. The results of this trial highlight the importance of ambulatory BP monitoring in the design of hypertension clinical studies.
copHagerstown, MD
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pmid20921430
doi10.1161/HYPERTENSIONAHA.110.156976
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