Achieving BP goals with valsartan and HCTZ alone and in combination: pooled analysis of two randomized, double-blind, placebo-controlled studies.
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.


METHODS
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.
Nash
David T
DT
Upstate Medical University College of Medicine, Syracuse, NY 13202, USA. davidtnash@aol.com
Crikelair
Nora
N
Zappe
Dion
D
D000328:Adult; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D004232:Diuretics / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012189:Retrospective Studies; D013777:Tetrazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D014633:Valine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D000068756:Valsartan
D000959:Antihypertensive Agents; D004232:Diuretics; D010919:Placebos; D013777:Tetrazoles; D006852:Hydrochlorothiazide; D000068756:Valsartan; D014633:Valine