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 withhydrochlorothiazide, 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 overall population (N=1313) and in patient subgroups. Patients treated with initial combination therapy reached goal in 27-56% of the time needed for those treated with monotherapy. Combination therapy was well tolerated and was associated with a decreased incidence of hypokalemia compared with hydrochlorothiazide monotherapy. CONCLUSIONS: Compared with monotherapy, combination therapy resulted in greater reductions in BP and achievement of goal BP in a shorter period of time. Although interpretation of this study is subject to the limitations associated with any post-hoc analysis, the results suggest that initiating treatment with combination therapy may be considered for expedient and effective BP control.
RCT Entities:
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 hypertensivepatients 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 overall population (N=1313) and in patient subgroups. Patients treated with initial combination therapy reached goal in 27-56% of the time needed for those treated with monotherapy. Combination therapy was well tolerated and was associated with a decreased incidence of hypokalemia compared with hydrochlorothiazide monotherapy. CONCLUSIONS: Compared with monotherapy, combination therapy resulted in greater reductions in BP and achievement of goal BP in a shorter period of time. Although interpretation of this study is subject to the limitations associated with any post-hoc analysis, the results suggest that initiating treatment with combination therapy may be considered for expedient and effective BP control.