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

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.