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Safety and efficacy of aliskiren/amlodipine/hydrochlorothiazide triple combination in patients with moderate to severe hypertension: a 54-week, open-label study.
MedLine Citation:
PMID:  23205748     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
J Clin Hypertens (Greenwich). 2012; 14:821-827. ©2012 Wiley Periodicals, Inc. Combination antihypertensive therapies are recommended to attain blood pressure (BP) targets especially in high-risk patients in whom rapid and pronounced BP control is essential. This 28- to 54-week, open-label, multicenter study evaluated the safety and efficacy of a triple combination, aliskiren with amlodipine and hydrochlorothiazide (HCTZ), in patients with moderate to severe hypertension. Following a washout period of up to 4 weeks, patients received aliskiren/HCTZ 300/12.5 mg for 1 week, followed by add-on amlodipine 5 mg for 1 week. Thereafter, the doses of amlodipine and HCTZ were doubled. The first 206 of 564 patients who completed 28 weeks of study continued for an additional 26 weeks. Safety was assessed by recording all adverse events. Efficacy variables included changes in BP from baseline to endpoint and BP control rate. Of 564 patients, 493 completed the study. Peripheral edema (9.4%), headache (5.7%), nasopharyngitis (4.1%), and bronchitis (3.7%) were reported frequently. Clinically significant reductions in mean sitting systolic BP/mean sitting diastolic BP from baseline (-34.2/-20.3 mm Hg and -37.3/-21.8 mm Hg at weeks 28 and 54, respectively) were observed. Corresponding BP control rates were 69.1% and 77.1%. The aliskiren/amlodipine/HCTZ combination in patients with moderate to severe hypertension was well tolerated and provided clinically significant BP reductions and effective BP control.
Authors:
Alexander V Murray; Wolfgang Koenig; Juan Garcia-Puig; Samir Patel; Alkaz Uddin Phd; Jack Zhang
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Publication Detail:
Type:  Journal Article     Date:  2012-08-28
Journal Detail:
Title:  Journal of clinical hypertension (Greenwich, Conn.)     Volume:  14     ISSN:  1751-7176     ISO Abbreviation:  J Clin Hypertens (Greenwich)     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-04     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100888554     Medline TA:  J Clin Hypertens (Greenwich)     Country:  United States    
Other Details:
Languages:  eng     Pagination:  821-7     Citation Subset:  IM    
Copyright Information:
© 2012 Wiley Periodicals, Inc.
Affiliation:
From PharmQuest, Greensboro, NC;Division of Cardiology, Department of Internal Medicine II, University of Ulm Medical Centre, Ulm, Germany;Division of Internal Medicine, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain;Novartis Pharmaceuticals Corporation, East Hanover, NJ.
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