Comparison of valsartan/hydrochlorothiazide combination therapy at doses up to 320/25 mg versus monotherapy: A double-blind, placebo-controlled study followed by long-term combination therapy in hypertensive adults

Pool, James L.; Glazer, Robert; Weinberger, Myron H.; Alvarado, Roxanne; Huang, Jie; Graff, Alan

doi:10.1016/j.clinthera.2007.01.007

Cited by 82 publications

(59 citation statements)

References 17 publications

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“…Hypokalaemia associated with higher doses of HCTZ was attenuated with the co-administration of Val and HCTZ as reported previously. 17 A limitation to this report is the fact that the efficacy analyses were not pre-specified and the clinical trial was not specifically designed to address the objectives of this report. The probability estimates of reaching goal are less reliable at higher baseline BPs because of the small numbers of patients in this range.…”

Section: Discussionmentioning

confidence: 99%

“…Complete details of the study have been published previously. 17 A total of 1652 patients were enrolled into the single-blind period of the study, and 1346 patients with a mean sitting DBP (MSDBP) X95 and o110 mm Hg were randomly allocated into the double-blind treatment phase. The study assessed the antihypertensive efficacy and tolerability of once-daily dosing of Val/HCTZ combination therapy (160/12.5, 320/12.5 and 320/25 mg) compared with Val (160 and 320 mg), HCTZ (12.5 and 25 mg) and placebo.…”

Section: Methodsmentioning

confidence: 99%

“…17 Of the 675 patients included in the Val/HCTZ 320/25 mg, Val 320 mg, HCTZ 25 mg and placebo groups, 568 (84.2%) completed the study. Study discontinuation rates in the Val/HCTZ 320/25 mg, Val 320 mg, HCTZ 25 mg and placebo groups were 10.1, 19.4, 15.0 and 18.9%, respectively.…”

Section: Patient Populationmentioning

confidence: 99%

“…17 Of the patients in this post hoc data set, a total of 352 (52.1%) patients were men, 463 (68.6%) were Caucasian and 62 (9.2%) were diabetic. The mean age of the study population was 52.9 years with 102 (15.1%) patients X65 years of age.…”

Section: Patient Populationmentioning

confidence: 99%

“…2-6 K Studies have shown that the combination of an angiotensin receptor blocker, such as valsartan (Val), with the diuretic hydrochlorothiazide (HCTZ), has enhanced efficacy compared with component monotherapies and is well tolerated in hypertensive patients; [17][18][19][20] and, the single-pill combination has been recently approved in the United States as initial therapy.…”

Section: Conflict Of Interestmentioning

confidence: 99%

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Achieving blood pressure goal: initial therapy with valsartan/hydrochlorothiazide combination compared with monotherapy

et al. 2010

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The benefits of valsartan (Val)/hydrochlorothiazide (HCTZ) combination as initial treatment for hypertension were evaluated in a post hoc analysis of an 8-week, doubleblind, placebo-controlled, parallel-group trial. The highest dose of Val/HCTZ combination (320/25 mg), component monotherapies (Val 320 mg, HCTZ 25 mg) and placebo were selected for this analysis (N ¼ 675, 52.1% men, 68.6% Caucasians, mean age 52.9 years, baseline blood pressure (BP) 150.6/99.1 mm Hg). As soon as 2 weeks after initiation of active therapy, greater BP control rates were observed with Val/HCTZ (320/25 mg) compared with Val (320 mg), HCTZ (25 mg) and placebo. Similar results were observed in subgroups of patients with stage 1 and stage 2 hypertension, as well as in diabetic patients. As baseline BP increased, the probability of achieving mean sitting systolic BP (o140 and o130 mm Hg) and mean sitting diastolic BP control (o90 and o80 mm Hg), determined using a logistic regression model, decreased with all treatments. However, at all levels of baseline BP, the probability of achieving BP control was greater with Val/HCTZ combination. The Val/HCTZ combination was well tolerated with overall incidence of adverse events similar to that observed with monotherapy and placebo. These results support the use of Val/HCTZ combination as initial therapy in hypertensive patients unlikely to achieve BP control with a single agent.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Patient Populationmentioning

confidence: 99%

Section: Patient Populationmentioning

confidence: 99%