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.

• Authors: Dean J Kereiakes, Joel M Neutel
• Journal: Drugs in R&D (Drugs R D) Vol. 11 Issue 3 Pg. 251-7 (Sep 01 2011) ISSN: 1179-6901 [Electronic] New Zealand
• PMID: 21777013 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Antihypertensive Agents
• Imidazoles
• Tetrazoles
• Hydrochlorothiazide
• Olmesartan Medoxomil

Topics

• Adolescent
• Adult
• Antihypertensive Agents (adverse effects, pharmacokinetics, therapeutic use)
• Blood Pressure (drug effects)
• Cross-Over Studies
• Diabetes Mellitus, Type 2 (complications, metabolism)
• Double-Blind Method
• Drug Therapy, Combination (adverse effects, methods)
• Euphoria (drug effects)
• Female
• Humans
• Hydrochlorothiazide (adverse effects, therapeutic use)
• Hypertension (drug therapy, etiology, metabolism)
• Imidazoles (adverse effects, pharmacokinetics, therapeutic use)
• Male
• Middle Aged
• Olmesartan Medoxomil
• Prospective Studies
• Tetrazoles (adverse effects, pharmacokinetics, therapeutic use)
• Young Adult