Office and ambulatory blood pressure-lowering effects of combination valsartan/hydrochlorothiazide vs. hydrochlorothiazide-based therapy in obese, hypertensive patients

Abstract

The authors evaluated the blood pressure (BP)-lowering effects of combination valsartan/hydrochlorothiazide (HCTZ) vs. amlodipine/HCTZ in a 16-week, double-blind, randomized, forced-titration study and ambulatory BP monitoring (ABPM) substudy involving centrally obese hypertensive patients 40 years and older. Patients were started on valsartan/HCTZ 160/12.5 mg or HCTZ 12.5 mg monotherapy, force-titrated at week 4 to valsartan/HCTZ 320/25 mg and HCTZ 25 mg, respectively. The HCTZ group initiated amlodipine 5 mg at week 8 and 10 mg at week 12. A subset of patients had 24-hour ABPM at baseline and weeks 8 and 16. At week 16 in the intent-to-treat population (n=401), valsartan/HCTZ and amlodipine/HCTZ lowered office systolic BP (-30.6 vs. -28.3 mm Hg; P=.14). In the ABPM subgroup (n=111), valsartan/HCTZ was more effective than amlodipine/HCTZ in reducing 24-hour systolic BP (-20.6 vs. -14.5 mm Hg; P=.011). In obese hypertensive patients, valsartan/HCTZ reduced office BP similar to amlodipine/HCTZ but lowered 24-hour systolic BP more.

Trial registration: ClinicalTrials.gov NCT00425997.

© 2011 Wiley Periodicals, Inc.

Figures

Figure 1

Mean±standard error change from baseline to week 8 in (A) office blood pressure for the overall intent‐to‐treat population, (B) office blood pressure for the intent‐to‐treat ambulatory substudy population, and (C) 24‐hour blood pressure for the ambulatory substudy population. P values are based on least‐squares mean differences. ABPM indicates ambulatory blood pressure monitoring; HCTZ, hydrochlorothiazide; ITT, intent‐to‐treat; MADBP, mean ambulatory diastolic blood pressure; MASBP, mean ambulatory systolic blood pressure; MSDBP, mean sitting diastolic blood pressure; MSSBP, mean sitting systolic blood pressure.

Figure 2

Mean±standard error change from baseline to week 16 in (A) office blood pressure for the overall intent‐to‐treat population, (B) office blood pressure for the intent‐to‐treat ambulatory substudy population, and (C) 24‐hour blood pressure for the ambulatory substudy population. P values are based on least‐squares mean differences. *Patients received amlodipine starting at week 8. ABPM indicates ambulatory blood pressure monitoring; HCTZ, hydrochlorothiazide; ITT, intent‐to‐treat; MADBP, mean ambulatory diastolic blood pressure; MASBP, mean ambulatory systolic blood pressure; MSDBP, mean sitting diastolic blood pressure; MSSBP, mean sitting systolic blood pressure.

Figure 3

Hourly ambulatory blood pressure (BP) at the end of study in the ambulatory substudy population. *Patients received amlodipine starting at week 8. HCTZ indicates hydrochlorothiazide.