Document Detail

Long-term safety, tolerability and efficacy of aliskiren in combination with valsartan in patients with hypertension: a 6-month interim analysis.
MedLine Citation:
PMID:  18307835     Owner:  NLM     Status:  MEDLINE    
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 > or = 90 and < 110 mmHg) received a combination of aliskiren/valsartan 150/160 mg for 2 weeks followed by forced titration to aliskiren/valsartan 300/320 mg once daily for a targeted duration of 52 weeks. Optional hydrochlorothiazide (HCTZ) addition was allowed from week 8 for inadequate BP control (> or = 140/90 mmHg). The primary objective was to assess the safety of combination therapy; potassium elevations were a predefined safety outcome. BP was measured at regular intervals during the study. RESULTS: At the 6-month cut-off date, 512 patients (85.2%) were still ongoing with study treatment, and 192 patients had received at least one dose of HCTZ add-on during this period. Combination therapy was generally well-tolerated; the most commonly reported adverse events were headache (7.5%), dizziness (7.3%) and nasopharyngitis (7.2%). Ten patients (2.5%) receiving aliskiren/valsartan and two patients (1.0%) receiving aliskiren/valsartan/HCTZ had serum potassium elevations > 5.5 mmol/L. Only one patient (0.2%) exhibited potassium levels > or = 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 (< 140/90 mmHg; LOCF). CONCLUSIONS: Although lack of an active comparator group is a limitation of the study, our findings show that long-term treatment with the aliskiren/valsartan 300/320-mg combination provided clinically significant BP lowering, was well-tolerated and was associated with a very low rate of potassium elevations in patients with hypertension.
Steven G Chrysant; Alexander V Murray; Uta C Hoppe; Dan Dattani; Samir Patel; Huang Hsu; Jack Zhang
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Publication Detail:
Type:  Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2008-02-27
Journal Detail:
Title:  Current medical research and opinion     Volume:  24     ISSN:  1473-4877     ISO Abbreviation:  Curr Med Res Opin     Publication Date:  2008 Apr 
Date Detail:
Created Date:  2008-04-23     Completed Date:  2008-06-13     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0351014     Medline TA:  Curr Med Res Opin     Country:  England    
Other Details:
Languages:  eng     Pagination:  1039-47     Citation Subset:  IM    
University of Oklahoma, Oklahoma City, OK 73132, USA.
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MeSH Terms
Amides / pharmacology*,  therapeutic use
Angiotensin II Type 1 Receptor Blockers / adverse effects,  pharmacology*,  therapeutic use
Angiotensin-Converting Enzyme Inhibitors / adverse effects,  pharmacology*,  therapeutic use
Antihypertensive Agents / pharmacology*,  therapeutic use
Blood Pressure / drug effects
Drug Therapy, Combination
Fumarates / pharmacology*,  therapeutic use
Hydrochlorothiazide / pharmacology
Hyperkalemia / chemically induced
Hypertension / drug therapy*
Middle Aged
Renin / antagonists & inhibitors*
Renin-Angiotensin System / drug effects*
Risk Factors
Tetrazoles / pharmacology*,  therapeutic use
Time Factors
Valine / analogs & derivatives*,  pharmacology,  therapeutic use
Reg. No./Substance:
0/Amides; 0/Angiotensin II Type 1 Receptor Blockers; 0/Angiotensin-Converting Enzyme Inhibitors; 0/Antihypertensive Agents; 0/Fumarates; 0/Tetrazoles; 0/aliskiren; 137862-53-4/valsartan; 58-93-5/Hydrochlorothiazide; 7004-03-7/Valine; EC

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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