Seated cuff blood pressure-lowering efficacy of an olmesartan medoxomil-based treatment regimen in patients with type 2 diabetes mellitus

Abstract

Background: Hypertension is a common co-morbidity in patients with type 2 diabetes mellitus, and well tolerated, effective therapies are needed to achieve guideline-recommended blood pressure (BP) goals in these patients.

Objective: The aim of this study was to present the results of a prespecified analysis of key secondary endpoints from a 12-week, open-label, single-arm study evaluating the efficacy and safety of olmesartan medoxomil plus hydrochlorothiazide (HCTZ) in patients with hypertension and type 2 diabetes.

Study design and methods: After a placebo run-in period, 192 patients received olmesartan medoxomil 20 mg/day for 3 weeks. If BP remained ≥ 120/70 mmHg, patients were uptitrated at 3-week intervals to olmesartan medoxomil 40 mg/day, olmesartan medoxomil/HCTZ 40/12.5 mg/day, and olmesartan medoxomil/HCTZ 40/25 mg/day.

Main outcome measure: Endpoints evaluated in this analysis were the change from baseline in mean seated cuff BP (SeBP), proportions of patients achieving SeBP goals, and distribution of SeBP reductions.

Results: Mean SeBP was 158.1/90.0 mmHg at baseline. The mean ± standard error of BP reductions at 12 weeks for systolic and diastolic BP were 21.3 ± 1.1 mmHg and 9.8 ± 0.6 mmHg, respectively (p < 0.0001 for each). At the end of the study, the proportion of patients with diabetes achieving the recommended SeBP goal of <130/80 mmHg was 41.1%.

Conclusions: An olmesartan medoxomil ± HCTZ treatment regimen significantly reduced BP from baseline in patients with hypertension and type 2 diabetes.

Clinical trials registration: ClinicalTrials.gov identifier: NCT00403481.

Table I

Baseline demographics, clinical characteristics, and baseline blood pressure (BP) information^a,b

Fig. 1

Change from baseline in seated cuff blood pressure (SeBP) at week 12/last observation carried forward for the total cohort, patients with stage 1 hypertension, and patients with stage 2 hypertension. Data are mean ± standard error of the mean. p < 0.0001 for all reductions vs baseline. HCTZ = hydrochlorothiazide; OM = olmesartan medoxomil; SeDBP = seated cuff diastolic blood pressure; SeSBP = seated cuff systolic blood pressure; *p < 0.0001, **p < 0.001, *** p < 0.01, **** p-value not significant vs preceding treatment regimen.

Fig. 2

Cumulative seated cuff blood pressure (SeBP) goal achievement at week 12/last observation carried forward. The SeBP measurements are calculated using the total number of subjects in the treatment cohort (n = 192) with the last observation carried forward for patients who did not have a measurement at end of study. HCTZ = hydrochlorothiazide; OM = olmesartan medoxomil.

Fig. 3

The proportion of patients achieving prespecified systolic blood pressure (SBP) decreases at week 12. Percentages are calculated using the total number of subjects in the treatment efficacy cohort as the denominator. HCTZ = hydrochlorothiazide; OM = olmesartan medoxomil.