Published in:
01-10-2010 | Original Research Article
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
Published in: American Journal of Cardiovascular Drugs | Issue 5/2010
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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]