Achieving BP goals with valsartan and HCTZ alone and in combination: pooled analysis of two randomized, double-blind, placebo-controlled studies
Abstract
BACKGROUND: Most patients with hypertension will require combination therapy to achieve blood pressure (BP) goals, especially the elderly, obese, or those with stage 2 hypertension.
OBJECTIVE: To assess BP response and time to achieve BP goals in a diverse population of hypertensive patients treated with hydrochlorothiazide, valsartan, or a combination.
METHODS: For this secondary post-hoc analysis, data were pooled from two similar randomized, double-blind, 8-week trials that evaluated hydrochlorothiazide (12.5-25 mg) and valsartan (160 mg) monotherapies, their combination (160/12.5 mg), and placebo. Subgroups were defined by age, hypertension severity, and obesity. Adults with diastolic BP > or =95 and < or =115 mmHg were included. Goal rates were estimated from a logistic model with treatment, study, age group, race, and baseline body mass index as factors and baseline diastolic BP as a covariate. Kaplan-Meier estimates were used to calculate the time to achieve BP goals.
MAIN OUTCOME MEASURES: Efficacy variables were reductions from baseline to study end in systolic BP and diastolic BP, rates of achieving BP goals (<140/90 mmHg), and time to achieve BP goals. Adverse events were also reported for the pooled trials.
RESULTS: BP reductions at study end and goal achievement rates were greater with combination therapy (-20/15 mmHg and 72%, respectively) than with either monotherapy (valsartan 160 mg: -14/11 mmHg, 61%; hydrochlorothiazide 25 mg: -14/10 mmHg, 50%) for the…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 1,313 participants or records.
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