Efficacy of an olmesartan medoxomil-based treatment algorithm in patients stratified by age, race, or sex

Abstract

Demographic factors are known to influence the prevalence of hypertension, and evidence suggests that they may also influence the response of patients with hypertension to blood pressure (BP)-lowering therapies. To determine the effect of demographic factors on the efficacy and safety of an olmesartan medoxomil (OM)-based treatment regimen, we performed a prespecified subgroup analysis of a 12-week, randomized, placebo-controlled, titrate-to-goal study in patients with hypertension, stratifying patients into treatment groups according to age, sex, or race. After 12 weeks, OM-based therapy significantly reduced BP from baseline in blacks, non-blacks, men, women, and patients younger than 65 or 65 years and older compared with placebo, and enabled 51.9% to 79.5% of patients to achieve a BP goal of <140/90 mm Hg. The differences in BP-lowering efficacy of OM-based therapy between subgroups were not clinically significant, and treatment was generally well tolerated in all groups. This study demonstrates that an OM-based treatment algorithm is an effective and safe option for achieving recommended BP goal in patients with hypertension including blacks, non-blacks, men, women, and patients younger than 65 or 65 years and older.

Figure 1

Study design. Patients meeting inclusion criteria entered the 3‐week placebo run‐in phase prior to randomization. Patients were evaluated weekly during the placebo run‐in phase and those meeting inclusion criteria at visit 4 had their blood pressure (BP) assessed by ambulatory BP monitoring (ABPM) to confirm the presence of hypertension. Patients meeting the ABPM criteria were given the randomized study medication, and the 12‐week double‐blind treatment phase then began. Up‐titration to the next level of the treatment regimen could occur at any of the titration steps at weeks 3, 6, and 9. *Titration steps: (1) Patients with mean seated BP <120/80 mm Hg at any visit were not up‐titrated to the next dose level and were maintained on current dose. (2) Patients were up‐titrated if mean seated systolic BP was ≥120 mm Hg or mean seated diastolic DBP was ≥80 mm Hg at any visit. HCTZ indicates hydrochlorothiazide; OM, olmesartan medoxomil.

Figure 2

Least‐squares (LS) mean change (active treatment minus placebo) in  mm Hg from baseline in mean seated cuff diastolic and systolic blood pressure (SeDBP and SeSBP, respectively) in the subgroups at week 12 (last observation carried forward). ^aP<.0001 vs placebo; ^bP<.05 vs placebo; ^cP<.001 vs placebo. OM indicates olmesartan medoxomil.

Figure 3

Proportion of patients in the male, female, aged <65 years, aged ≥65 years, black, and non‐black populations at week 12 who achieved a blood pressure goal of <140/90 mm Hg. OM indicates olmesartan medoxomil.