| Long-term safety and efficacy of aliskiren and valsartan combination with or without the addition of HCT in patients with hypertension. | |
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MedLine Citation:
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PMID: 21062137 Owner: NLM Status: In-Process |
Abstract/OtherAbstract:
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OBJECTIVE: To assess the long-term safety and antihypertensive efficacy of aliskiren/valsartan 300/320 mg combination. METHODS: This was a 54-week, multicenter, open-label study (core phase), followed by a 26-week extension phase. Efficacy variables were change in msDBP and msSBP from baseline to endpoint (54-week and 80-week). Safety was assessed by monitoring and recording adverse events (AEs). ClinicalTrials.gov Identifier: NCT00386607 RESULTS: A total of 601 patients (msDBP ≥ 90 and <110 mmHg) entered the 54-week core study. Optional add-on HCT was allowed at week 10 onwards if BP was ≥ 140/90 mmHg at two consecutive visits. Of the 486 patients completed the core study, 180 patients entered the extension phase and received aliskiren/valsartan and add-on HCT (12.5 or 25 mg). Overall the combination of aliskiren/valsartan was well-tolerated and the majority of AEs were mild-to-moderate in severity. The incidence of SAEs was low (core phase: n = 22 [3.7%]; extension phase: n = 4 [2.2%]). Elevated serum potassium (>5.5 mmol/L at any time during the study) was observed in 21 (3.6%) patients. The majority of these elevations were transient and returned to normal in subsequent visits, and the discontinuation rate due to elevated serum potassium was low (0.3% [n = 2]). Decreased serum potassium levels (<3.5 mmol/L at any time during the study) was observed in 26 (4.4%) patients, mainly in patients receiving aliskiren/valsartan/HCT (n = 22; 7.1%). At the 54-week endpoint, a mean BP reduction of 20.5/13.4 mmHg from baseline (baseline BP: 152.9/97.0 mmHg) was observed and 66.9% (n = 398/595) of patients achieved BP control with aliskiren/valsartan with or without HCT. At the end of the extension phase (80-week endpoint), additional reduction in BP was obtained (overall, 28.8/18.3 mmHg) and 86.6% (n = 155/179) of patients achieved BP control with aliskiren/valsartan/HCT. A limitation is the absence of an active comparator group. Conclusion: Long-term treatment with the combination of aliskiren/valsartan with or without HCT provided clinically meaningful BP reductions and high rates of BP control and was well-tolerated. |
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Authors:
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Steven G Chrysant; Alexander V Murray; Uta C Hoppe; Dan Dattani; Samir Patel; Shannon Ritter; Jack Zhang |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't Date: 2010-11-09 |
Journal Detail:
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Title: Current medical research and opinion Volume: 26 ISSN: 1473-4877 ISO Abbreviation: Curr Med Res Opin Publication Date: 2010 Dec |
Date Detail:
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Created Date: 2010-11-16 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0351014 Medline TA: Curr Med Res Opin Country: England |
Other Details:
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Languages: eng Pagination: 2841-9 Citation Subset: IM |
Affiliation:
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University of Oklahoma, Oklahoma City, OK, USA. schrysant@yahoo.com |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00386607 |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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