Effectiveness and safety of high-dose valsartan monotherapy in hypertension treatment: the ValTop study.

15:00 EDT 25th October 2014 | BioPortfolio

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.

Affiliation

[1] Department of Clinical Medicine and Prevention, University of Milano-Bicocca, Milan, Italy [2] Department of Cardiology, S.Luca Hospital, IRCCS, Istituto Auxologico Italiano, Milan, Italy.

Journal Details

This article was published in the following journal.

Name: Hypertension research : official journal of the Japanese Society of Hypertension
ISSN: 1348-4214
Pages:

Links

PubMed Articles [38404 Associated PubMed Articles listed on BioPortfolio]

Randomized trial comparing the effects of a low-dose combination of nifedipine GITS and valsartan versus high-dose monotherapy on central hemodynamics in patients with inadequately controlled hypertension: FOCUS study.

Measurement of central blood pressure provides prognostic information beyond conventional peripheral blood pressure (BP). However, few studies have directly compared the effects of antihypertensives o...

Clinical utility of valsartan in treatment of children and adolescents with high blood pressure.

The incidence of hypertension in the pediatric population has been increasing secondary to lifestyle changes in children and adolescents. Recent studies have enhanced our understanding of the treatmen...

Efficacy and Safety of High-Dose Propranolol for the Management of Infant Supraventricular Tachyarrhythmias.

To report our experience with high-dose propranolol monotherapy for prophylaxis and treatment of infant supraventricular arrhythmias (SAs).

Efficacy and tolerability of telmisartan plus amlodipine in asian patients not adequately controlled on either monotherapy or on low-dose combination therapy.

Objective. To evaluate the efficacy and safety of the telmisartan plus amlodipine (T/A) single-pill combination (SPC) in Asian patients with hypertension whose blood pressure (BP) was not adequately c...

Real-world clinical experience of amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide in hypertension: the Excite study.

Abstract Objective: The EXCITE (Clinical EXperienCe of amlodipine and valsarTan in hypErtension) study was designed to evaluate the effectiveness, tolerability and adherence of amlodipine/valsartan (A...

Clinical Trials [10542 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension

This is a double-blind study to evaluate the reduction in systolic blood pressure using a therapy initiated with valsartan 160 mg or valsartan + hydrochlorothiazide (HCTZ) 160/12.5 mg comp...

Demonstrate Non-inferiority of Combination of 5 mg Amlodipine and 80 mg Valsartan to 160 mg Valsartan

The purpose of the present study is to assess the non-inferiority of the efficacy and safety of fixed dose combination of 5 mg amlodipine and 80 mg valsartan compared to 160 mg valsartan i...

A Study to Compare Treating Hypertension With Valsartan 160 MG to Valsartan 320 Mg

The purpose of this was to evaluate valsartan 320mg compared to valsartan 160 mg in terms of blood pressure reduction in a patient population of mild to moderate hypertensives

Efficacy and Safety of Lercanidipine and Valsartan in Patients With Essential Hypertension

The purpose of this study is to evaluate the safety and efficacy of fixed combination of lercanidipine (10 mg or 20 mg) and valsartan (80 mg or 160 mg), lercanidipine and valsartan alone i...

Efficacy and Safety of Valsartan and the Combination of Valsartan and Simvastatin

This study will assess and compare the efficacy and safety of valsartan and the combination of valsartan and simvastatin in patients with high blood pressure and high cholesterol.

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.

Freedom from exposure to danger and protection from the occurrence or risk of injury or loss. It suggests optimal precautions in the workplace, on the street, in the home, etc., and includes personal safety as well as the safety of property.

The branch of pharmacology that deals directly with the effectiveness and safety of drugs in humans.

Search BioPortfolio:
Loading
Advertisement

Relevant Topics

Cardiology
Latest News Clinical Trials Research Drugs Reports Corporate
Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...

Nephrology - kidney function
Latest News Clinical Trials Research Drugs Reports Corporate
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...

Advertisement