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New Data Shows Blood Pressure Reduction Therapy with BENICAR(R) and BENICAR HCT(R) Effectively Reduces Blood Pressure in Elderly Patients to Target Blood Pressure
Date:5/8/2009

BeniSILVER Study

BeniSILVER was a 14-15 week, prospective, open-label, single-arm, dose-titration, study to investigate the safety and BP-lowering efficacy of the proposed titration of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide in 178 patients age 65 years or older with mild to moderate (Stage 1) or challenging (Stage 2) hypertension. Following a 2-3 week placebo period, 176 patients started olmesartan (OM) 20 mg. If SBP remained greater than or equal to 120 mm Hg or DBP remained greater than or equal to 70 mm Hg, patients were titrated at 3-week intervals until BP was normalized as follows: OM 40mg, olmesartan medoxomil/hydrochlorothiazide (OM/HCTZ) 40mg/12.5mg and OM/HCTZ 40mg/25mg. Patients (asymptomatic) with BP <120/70 mm Hg continued on their current assigned dose (maintenance treatment) unless BP was uncontrolled, SBP greater than or equal to 140mm Hg and/or DBP greater than or equal to 90 mm Hg, at which time the titration schedule was resumed.

The primary endpoint was change in mean SBP from baseline after 12 weeks of treatment as measured by a 24-hour ABPM. The secondary endpoints included change from baseline in mean 24-hour ambulatory DBP, change from baseline in mean SeSBP and SeDBP and proportion of patients achieving BP goal (<140/90, <135/85, <130/80 & <120/80 mm Hg), at each titration period and study end and a subgroup analysis by age (greater than or equal to 75 years or >75 years). Mean baseline ABPM was 148.8/80.9 mm Hg and mean baseline seated BP was 165.5/87.7 mm Hg, indicating predominant systolic hypertension in this elderly patient cohort with a mean age of 71.9 years and 65.9 percent challenging (Stage 2) hypertension.

Treatment emergent adverse events (TEAE) were seen in 56 patients, 32.6% of the treatment population. The most common were dizziness (8 patients, 4.5%) diarrhea (4 patients, 2.2%), upper respiratory tract infection (4 patients, 2.2%)
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SOURCE Daiichi Sankyo, Inc.
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