Open AccessAmlodipine and Valsartan Combined and as Monotherapy in Stage 2, Elderly, and Black Hypertensive Patients: Subgroup Analyses of 2 Randomized, Placebo‐Controlled Studies
Author(s) -
Smith Timothy R.,
Philipp Thomas,
Vaisse Bernard,
Bakris George L.,
Yen Joseph,
Glazer Robert
Publication year - 2007
Publication title -
the journal of clinical hypertension
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.909
H-Index - 67
eISSN - 1751-7176
pISSN - 1524-6175
DOI - 10.1111/j.1524-6175.2007.06689.x
Subject(s) - medicine , valsartan , amlodipine , placebo , combination therapy , randomized controlled trial , blood pressure , post hoc analysis , adverse effect , subgroup analysis , cardiology , confidence interval , alternative medicine , pathology
Patients with difficult to control hypertension typically require 2 or more agents to achieve goal blood pressure (BP) levels. Fixed‐dose combination therapies with lower doses generally are well tolerated and more effective than higher‐dose monotherapy. The authors performed prespecified and post hoc subgroup analyses of 2 double‐blind, randomized, placebo‐controlled trials that assessed the efficacy and safety of amlodipine and valsartan, alone and in combination, in patients with mild to moderate hypertension. Patients were randomized to amlodipine (study 1: 2.5 or 5 mg/d; study 2: 10 mg/d), valsartan (study 1: 40, 80, 160, or 320 mg/d; study 2: 160 or 320 mg/d), combination therapy across the same dose ranges, or placebo. Analyses were performed on changes from baseline in mean sitting systolic and diastolic BP and the occurrence of adverse events in specific subgroups of patients (ie, those with stage 2 hypertension [post hoc], the elderly [65 years or older], and blacks [both prespecified]). Amlodipine + valsartan combination therapy was associated with greater BP‐lowering effects in the subgroups compared with each respective monotherapy and placebo. These findings were consistent with the primary efficacy analysis results from the overall study populations. Combination regimens were generally well tolerated by all patient subgroups.