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Treatment with aliskiren/amlodipine combination in patients with moderate-to-severe hypertension: a randomised, double-blind, active comparator trial.
MedLine Citation:
PMID:  22897460     Owner:  NLM     Status:  In-Data-Review    
Aims:  To assess the extent of reduction in blood pressure (BP) of aliskiren/amlodipine combination therapy compared with amlodipine monotherapy in moderate-to-severe hypertensive patients. Methods:  This was an 8-week multicentre, randomised, double-blind study. After a 1-to 4-week washout period, eligible patients [mean sitting systolic blood pressure (msSBP) ≥ 160 to < 200 mmHg] were randomised to receive a once-daily dose of aliskiren/amlodipine 150/5 mg (n = 244) or amlodipine 5 mg (n = 241) for 1 week, followed by up-titration to aliskiren/amlodipine 300/10 mg or amlodipine 10 mg for 7 weeks. Efficacy outcome measures included change from baseline to week 8 endpoint in msSBP (primary endpoint), mean sitting diastolic blood pressure (msDBP), and BP control rate (< 140/90 mmHg). Safety was assessed by monitoring and recording all adverse events (AEs) and laboratory abnormalities. Results:  Patients' demographic characteristics were balanced between the two groups, mean baseline BP being 171.0/94.3 mmHg for aliskiren/amlodipine and 171.8/95.6 mmHg for amlodipine. Of 485 randomised patients, 433 (89.3%) completed the study. At week 8 endpoint, combination therapy resulted in significantly greater msSBP/msDBP reductions and BP control rate, compared with monotherapy (all: p ≤ 0.0001). The overall incidence of AEs was similar between the two groups. The most commonly reported AE was peripheral oedema with the incidence lower for combination therapy (14.4%) than for monotherapy (18.3%). Conclusion:  In this population with considerably elevated BP, use of aliskiren/amlodipine combination showed significantly greater BP reductions and allowed more patients to achieve BP control compared with amlodipine monotherapy, with no additional safety concerns.
R C Braun-Dullaeus; S B Shustov; C Alvarez; G G Rogelio; J Zhang; S Hristoskova; D A Häring
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  International journal of clinical practice     Volume:  66     ISSN:  1742-1241     ISO Abbreviation:  Int. J. Clin. Pract.     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-08-17     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9712381     Medline TA:  Int J Clin Pract     Country:  England    
Other Details:
Languages:  eng     Pagination:  834-42     Citation Subset:  IM    
Copyright Information:
© 2012 Blackwell Publishing Ltd.
Otto-von-Guericke-University, Magdeburg, Germany State Educational Institution of High Professional Education, St. Petersburg, Russia ABS Centelles, Barcelona, Spain St. Luke's Medical Center, Quezon City, Philippines Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA Novartis Pharma AG, Basel, Switzerland.
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