Universität zu Köln

Chrysant, Steven G., Murray, Alexander V., Hoppe, Uta C., Dattani, Dan, Patel, Samir, Ritter, Shannon and Zhang, Jack (2010). Long-term safety and efficacy of aliskiren and valsartan combination with or without the addition of HCT in patients with hypertension. Curr. Med. Res. Opin., 26 (12). S. 2841 - 2850. ABINGDON: TAYLOR & FRANCIS LTD. ISSN 1473-4877

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Abstract

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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Chrysant, Steven G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Murray, Alexander V. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hoppe, Uta C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dattani, Dan UNSPECIFIED UNSPECIFIED UNSPECIFIED Patel, Samir UNSPECIFIED UNSPECIFIED UNSPECIFIED Ritter, Shannon UNSPECIFIED UNSPECIFIED UNSPECIFIED Zhang, Jack UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-491318
DOI:	10.1185/03007995.2010.528282
Journal or Publication Title:	Curr. Med. Res. Opin.
Volume:	26
Number:	12
Page Range:	S. 2841 - 2850
Date:	2010
Publisher:	TAYLOR & FRANCIS LTD
Place of Publication:	ABINGDON
ISSN:	1473-4877
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language RENIN-ANGIOTENSIN SYSTEM; ACUTE MYOCARDIAL-INFARCTION; DIABETIC-NEPHROPATHY; UNITED-STATES; HIGH-RISK; INHIBITOR; BLOCKADE; HYDROCHLOROTHIAZIDE; AMLODIPINE; EXPERIENCE Multiple languages Medicine, General & Internal; Medicine, Research & Experimental Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/49131