An olmesartan medoxomil-based treatment algorithm is effective in achieving 24-hour BP control in patients with type 2 diabetes mellitus, regardless of age, race, sex, or severity of hypertension: subgroup analysis of the BENIFICIARY study.

Abstract

BACKGROUND:

Hypertension often occurs concomitantly with diabetes mellitus, such that >50% of adults with type 2 diabetes have hypertension. These individuals are at a greater risk of developing renal and cardiovascular disease. The currently recommended BP goal of <130/80 mmHg for patients with type 2 diabetes is achieved in only 37.5% of treated patients with diabetes and hypertension.

METHODS:

The antihypertensive efficacy of olmesartan medoxomil (OM) ± hydrochlorothiazide (HCTZ) was investigated in prespecified subgroups (age <65/≥65 years, Blacks/non-Blacks, males/females, or stage 1/stage 2 hypertension) of patients with hypertension and type 2 diabetes enrolled in an open-label, single-arm study (n = 192). Patients started treatment with OM 20 mg/day and were uptitrated at 3-week intervals to OM 40, OM/HCTZ 40/12.5, and OM/HCTZ 40/25 mg/day if BP was ≥120/70 mmHg. The primary endpoint was the change in mean 24-hour ambulatory SBP from baseline to week 12, assessed by mean 24-hour ambulatory BP monitoring. Secondary endpoints included changes in mean 24-hour ambulatory DBP, mean daytime ambulatory BP, mean nighttime ambulatory BP, and mean office seated BP, and the proportions of patients achieving prespecified ambulatory BP targets.

SETTING:

This was a multicenter study (24 sites) that took place between November 2006 and November 2007 in the US.

RESULTS:

BP reductions were significant (p < 0.0001) and similar among subgroups of patients with type 2 diabetes. Following dose titration to OM/HCTZ 40/25 mg/day, similar proportions of patients in the age, race, and sex subgroups (approximately 60-64% across these subgroups) achieved an ambulatory BP target of <130/80 mmHg. A larger proportion of patients with type 2 diabetes and stage 1 hypertension achieved this same goal compared with patients with stage 2 hypertension (75% vs 46.3%). The combination of OM/HCTZ was well tolerated in all patient subgroups irrespective of age, race, sex, or hypertension severity.

CONCLUSIONS:

In this open-label study, OM/HCTZ combination therapy was efficacious and well tolerated in subgroups of patients with diabetes and hypertension. [Clinical Trials Registry Number: NCT00403481].

• Authors: Joel M Neutel, Dean J Kereiakes, BENIFICIARY Investigators
• Journal: American journal of cardiovascular drugs : drugs, devices, and other interventions (Am J Cardiovasc Drugs) Vol. 10 Issue 5 Pg. 289-303 ( 2010) ISSN: 1175-3277 [Print] New Zealand
• PMID: 20712386 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antihypertensive Agents
• Imidazoles
• Tetrazoles
• Olmesartan Medoxomil

Topics

• Adult
• Age Factors
• Aged
• Algorithms
• Antihypertensive Agents (therapeutic use)
• Blood Pressure (drug effects)
• Diabetes Mellitus, Type 2 (complications, physiopathology)
• Female
• Humans
• Hypertension (drug therapy, ethnology)
• Imidazoles (therapeutic use)
• Male
• Middle Aged
• Olmesartan Medoxomil
• Prospective Studies
• Sex Characteristics
• Tetrazoles (therapeutic use)