Effectiveness of initiating treatment with valsartan/hydrochlorothiazide in patients with stage-1 or stage-2 hypertension

Abstract

This prospective, 6-week, multicenter, double-blind study examined the benefits of initiating treatment with combination valsartan/hydrochlorothiazide (HCTZ) compared with initial valsartan monotherapy for 648 patients with stage-1 or stage-2 hypertension (age=52.6±10 years; 54% male; baseline blood pressure (BP)=161/98 mm Hg, 32% stage 1). Patients were randomized to valsartan 80 mg (V-low), valsartan 160 mg (V-high) or valsartan/HCTZ 160/12.5 mg (V/HCTZ), and electively titrated after weeks 2 and 4 to the next dosage level (maximum dose valsartan/HCTZ 160/25 mg) if BP remained >140/90 mm Hg. At end of the study, patients initiated with V/HCTZ required less titration steps compared with the initial valsartan monotherapy groups (63 vs 86% required titration by study end, respectively) and reached the target BP goal of <140/90 mm Hg in a shorter period of time (2.8 weeks) (P<0.0001) vs V-low (4.3 weeks) and V-high (3.9 weeks). Initial combination therapy was also associated with higher BP control rates and greater reductions in both systolic and diastolic BP from baseline (63%, −27.7±13/–15.1±8 mm Hg) compared with V-low (46%, −21.2±13/−11.4±8 mm Hg, P<0.0001) or V-high (51%, −24.0±13/−12.0±10 mm Hg, P<0.01). Overall and drug-related AEs were mild to moderate and were similar between V/HCTZ (53.1 and 14.1%, respectively) and the two monotherapy groups, V-low (50.5 and 13.8%) and V-high (50.7 and 11.8%). In conclusion, initiating therapy with a combination of valsartan and low-dose HCTZ results in early, improved BP efficacy with similar tolerability as compared with starting treatment with a low or higher dose of valsartan for patients with stage-1 and stage-2 hypertension.

Efficacy and safety of valsartan compared to enalapril in hypertensive children

“…Though the number of discontinuations leading to study drug related AEs were higher in the valsartan group, they were mild to moderate in nature, and the only event that occurred in more than one patient was nausea. In addition, a previously conducted study in 6-16 year old patients found valsartan to be well tolerated [24] and it has also been shown to have a good tolerability profile in a number of different adult patient populations across a multitude of clinical studies [18][19][20]33]. …”

“…Valsartan, a well known ARB, has proven efficacy and safety when used either as monotherapy or in combination to treat hypertension in adults [18][19][20]. A doseresponse study in children aged 6-16 years demonstrated that valsartan was efficacious and well tolerated in doses ranging from 10 to 160 mg [21].…”

Efficacy and safety of valsartan in hypertensive children 6 months to 5 years of age

“…Valsartan is an ARB that has proven efficacy and safety when used either as monotherapy or in combination to treat hypertension in adults [14][15][16][17]. This ARB has also demonstrated efficacy and safety in doses ranging from 10 to 160 mg in children aged 6-16 years [18].…”

Characterization And Compatibility Studies Of Valsartan With Pharmaceutical Excipients

“…Hypertension is one of the most prevalent chronic adult illnesses today and cannot be cured, but it can be controlled [1]. The pharmacological treatment for control of hypertension utilizes various drug therapies, single doses or associations of diuretics, beta-blockers, calcium channel blockers, angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor (AT1) antagonist (ARA) [2][3][4][5]. Valsartan (VAL, Figure 1) is one of the angiotensin II receptor (AT1) antagonists recommended for treatment of hypertension, postmyocardial infarction or congestive heart failure and chemically it is N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5yl)[1,1′-biphenyl]-4-yl]methyl]-L-valine1.…”