Effectiveness and safety of high-dose valsartan monotherapy in hypertension treatment: the ValTop study.
Summary of "Effectiveness and safety of high-dose valsartan monotherapy in hypertension treatment: the ValTop study."
Early combination therapy is increasingly recommended in hypertension management because of increased risk of adverse effects with high-dose monotherapy. However, this risk is not necessarily increased for high doses of angiotensin receptor blockers (ARB). ValTop study compared efficacy and safety of high vs. conventional dose of valsartan in hypertensive patients. ValTop was a controlled, randomized, double-blind trial. Of 6035 screened subjects, 4004 mild-to-moderate hypertensive patients (mean seated diastolic blood pressure (MSDBP) 90-109 mm Hg) started 4-week open-label treatment with valsartan 160 mg. Of them, 3776 were randomized to receive valsartan 160 mg (N=1900) or 320 mg (N=1876) o.d. for 4 weeks. In 28-week open-label extension study, all participating patients (N=642) received valsartan 320 mg. Valsartan 160 mg reduced MSDBP by 10.0 mm Hg in the initial open-label phase. Further BP reductions in the double-blind phase were significantly (P<0.0001) greater in the 320 mg group than in the 160 mg group for MSDBP (1.6+/-0.18 mm Hg vs. 0.5+/-0.18 mm Hg) and mean seated systolic BP (3.3+/-0.31 mm Hg vs. 0.7+/-0.31 mm Hg). The size of the additional effect of the 320 mg dose on BP was similar in subjects controlled or not by the initial 160 mg dose. Adverse event (AE) rates were similar in both treatment groups, drug-related AEs occurring in <5% of subjects in each phase. High-dose valsartan is safe and effective in uncomplicated mild-to-moderate hypertension independently of the initial response to a moderate dose. High-dose ARB monotherapy may thus be a viable option in hypertension management.Hypertension Research advance online publication, 5 August 2010; doi:10.1038/hr.2010.120.
 Department of Clinical Medicine and Prevention, University of Milano-Bicocca, Milan, Italy  Department of Cardiology, S.Luca Hospital, IRCCS, Istituto Auxologico Italiano, Milan, Italy.
This article was published in the following journal.
Name: Hypertension research : official journal of the Japanese Society of Hypertension
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/20686486
- DOI: http://dx.doi.org/10.1038/hr.2010.120
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Medical and Biotech [MESH] Definitions
Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, practicability, etc., of these interventions in individual cases or series.
The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.
Method in which repeated blood pressure readings are made while the patient undergoes normal daily activities. It allows quantitative analysis of the high blood pressure load over time, can help distinguish between types of HYPERTENSION, and can assess the effectiveness of antihypertensive therapy.
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The branch of pharmacology that deals directly with the effectiveness and safety of drugs in humans.