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 20mg/day for 3 weeks. If BP remained ≥120/70mmHg, patients were uptitrated at 3-week intervals to olmesartanmedoxomil 40mg/day, olmesartan medoxomil/HCTZ 40/12.5mg/day, and olmesartan medoxomil/HCTZ 40/25mg/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 158.1/90.0mmHg at baseline. The mean±standard error of BP reductions at 12 weeks for systolic and diastolic BP were 21.3±1.1mmHg 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