Long-term safety, tolerability and efficacy of aliskiren in combination with valsartan in patients with hypertension: a 6-month interim analysis

ABSTRACT Background: Renin-angiotensin system (RAS) blockade with ACE inhibitor and/or angiotensin receptor blocker therapy can lead to increased potassium levels, hence the need to assess dual blockade involving a direct renin inhibitor. Here we report the results of a pre-planned 6-month interim a...

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Published in:Current medical research and opinion 2008-04, Vol.24 (4), p.1039-1047
Main Authors: Chrysant, Steven G., Murray, Alexander V., Hoppe, Uta C., Dattani, Dan, Patel, Samir, Hsu, Huang, Zhang, Jack
Format: Article
Language:English
Subjects:
Aged
Amides - pharmacology
Amides - therapeutic use
Angiotensin II Type 1 Receptor Blockers - adverse effects
Angiotensin II Type 1 Receptor Blockers - pharmacology
Angiotensin II Type 1 Receptor Blockers - therapeutic use
Angiotensin-Converting Enzyme Inhibitors - adverse effects
Angiotensin-Converting Enzyme Inhibitors - pharmacology
Angiotensin-Converting Enzyme Inhibitors - therapeutic use
Antihypertensive Agents - pharmacology
Antihypertensive Agents - therapeutic use
Blood Pressure - drug effects
Drug Therapy, Combination
Female
Fumarates - pharmacology
Fumarates - therapeutic use
Humans
Hydrochlorothiazide - pharmacology
Hyperkalemia - chemically induced
Hypertension - drug therapy
Male
Middle Aged
Renin - antagonists & inhibitors
Renin-Angiotensin System - drug effects
Risk Factors
Tetrazoles - pharmacology
Tetrazoles - therapeutic use
Time Factors
Valine - analogs & derivatives
Valine - pharmacology
Valine - therapeutic use
Valsartan
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Summary:ABSTRACT Background: Renin-angiotensin system (RAS) blockade with ACE inhibitor and/or angiotensin receptor blocker therapy can lead to increased potassium levels, hence the need to assess dual blockade involving a direct renin inhibitor. Here we report the results of a pre-planned 6-month interim analysis of a long-term, open-label study examining the safety, tolerability and efficacy of the aliskiren/valsartan 300/320-mg combination in patients with hyper­tension. Methods: A total of 601 patients with hyper­tension (msDBP ≥ 90 and  5.5 mmol/L. Only one patient (0.2%) exhibited potassium levels ≥ 6.0 mmol/L during this period and the patient was treated with aliskiren/valsartan. Mean msSBP/DBP reductions of 22.3/14.4 mmHg were observed at 6-month endpoint (LOCF analysis) and 73.4% of patients achieved BP control (
ISSN:0300-7995
1473-4877
DOI:10.1185/030079908X280581