Document Detail

Divergent results using clinic and ambulatory blood pressures: report of a darusentan-resistant hypertension trial.
MedLine Citation:
PMID:  20921430     Owner:  NLM     Status:  MEDLINE    
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<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.
George L Bakris; Lars H Lindholm; Henry R Black; Henry Krum; Stuart Linas; Jennifer V Linseman; Sarah Arterburn; Philip Sager; Michael Weber
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-10-04
Journal Detail:
Title:  Hypertension     Volume:  56     ISSN:  1524-4563     ISO Abbreviation:  Hypertension     Publication Date:  2010 Nov 
Date Detail:
Created Date:  2010-10-21     Completed Date:  2010-11-10     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7906255     Medline TA:  Hypertension     Country:  United States    
Other Details:
Languages:  eng     Pagination:  824-30     Citation Subset:  IM    
University of Chicago, Department of Medicine, Hypertensive Disease Unit, Chicago, Ill, USA.
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MeSH Terms
Antihypertensive Agents / therapeutic use
Blood Pressure / drug effects*
Blood Pressure Monitoring, Ambulatory*
Guanfacine / therapeutic use
Hypertension / drug therapy*
Intention to Treat Analysis
Middle Aged
Phenylpropionates / therapeutic use*
Pyrimidines / therapeutic use*
Receptors, Endothelin / antagonists & inhibitors*
Treatment Outcome
Reg. No./Substance:
0/Antihypertensive Agents; 0/LU 135252; 0/Phenylpropionates; 0/Pyrimidines; 0/Receptors, Endothelin; 29110-47-2/Guanfacine
Comment In:
Hypertension. 2010 Nov;56(5):806-7   [PMID:  20921424 ]

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