In the prospective, open-label, titrate-to-goal Blood Pressure Control in All Subgroups With Hypertension (BP-CRUSH) study, 999 patients with hypertension uncontrolled on monotherapy (mean age, 55.6AE11.4 years; baseline blood pressure [BP], 153.7AE9.2 ⁄ 91.9AE8.6 mm Hg) were switched to fixed-dose amlodipine ⁄ olmesartan medoxomil (AML ⁄ OM) 5 ⁄ 20 mg. Patients were uptitrated every 4 weeks to AML ⁄ OM 5 ⁄ 40 mg and 10 ⁄ 40 mg to achieve BP <120 ⁄ 70 mm Hg. Patients were subsequently uptitrated every 4 weeks to AML ⁄ OM+hydrochlorothiazide (HCTZ) 10 ⁄ 40+12.5 mg and 10 ⁄ 40+25 mg to achieve BP <125 ⁄ 75 mm Hg. The primary end point, the cumulative percentage of patients achieving seated systolic BP <140 mm Hg (<130 mm Hg for patients with diabetes) by week 12, was 75.8%. The mean (AEstandard error) BP changes from baseline during the titration periods ranged from )14.2AE0.4 mm Hg ⁄ )7.7AE0.3 mm Hg for AML ⁄ OM 5 ⁄ 20 mg to )25.1AE0.7 mm Hg ⁄ )13.7AE0.4 mm Hg for AML ⁄ OM+HCTZ 10 ⁄ 40+25 mg. By week 20, the cumulative BP threshold of <140 ⁄ 90 mm Hg was achieved by 90.3% of patients. An ambulatory BP monitoring substudy (n=243) showed that 24-hour efficacy was maintained. Treatment-emergent adverse events (TEAEs), mostly mild to moderate in severity, occurred in 529 patients (53.0%). Drug-related TEAEs occurred in 255 patients (25.5%). This well-tolerated, treat-to-goal algorithm enabled a large proportion of patients with uncontrolled hypertension on monotherapy to safely achieve BP control on single-pill AML ⁄ OM combination therapy or triple therapy with the addition of HCTZ. J Clin Hypertens (Greenwich).
This study examined the effect of olmesartan medoxomil (OM) AE hydrochlorothiazide (HCTZ) on mean 24-hour ambulatory blood pressure, mean seated cuff (Se) blood pressure (BP), and SeBP goal achievement in elderly (65 years and older) patients with hypertension. After a 2-to 3-week placebo run-in period, patients received OM 20 mg, up-titrated to OM 40 mg, and then added HCTZ 12.5 mg to 25 mg in a stepwise manner at 3-week intervals if SeBP remained !120 ⁄ 70 mm Hg. The primary end point was change from baseline in mean 24-hour ambulatory systolic BP. At study end, mean 24-hour ambulatory BP had decreased by 25.7 ⁄ 12.3 mm Hg (n=150) and mean SeBP by 25.4 ⁄ 10.5 mm Hg (n=176; all P<.00001 vs baseline). Drug-related treatment-emergent adverse events, most commonly dizziness (3.4%), hypotension (2.2%), and headache (1.1%), were observed in 11.8% of patients. An OM-based treatment algorithm effectively lowers BP in an elderly patient population throughout the 24-hour dosing interval without compromising tolerability.
In this open-label ABPM study, an OM +/- HCTZ based treatment regimen safely and significantly reduced BP in patients with hypertension and type 2 diabetes when assessed by 24-hour ABPM.
The aim of the present study was to use ambulatory blood pressure (BP) monitoring (ABPM) to determine the efficacy of a fixed-dose combination of amlodipine (AML) and olmesartan medoxomil (OM) over the 24-hour dosing interval. This 12-week, titrate-to-goal study was conducted in 185 patients with hypertension. Patients were initially treated with AML 5 mg/ day and uptitrated to AML/OM 5/20, 5/40, and 10/40 mg/day every 3 weeks if mean seated BP (SeBP) was ≥ 120/80 mmHg. The primary efficacy endpoint was the change from baseline in mean 24-hour systolic BP at week 12 as assessed by ABPM. At baseline, the mean 24-hour ambulatory BP (± standard deviation [SD]) was 144.8 ± 11.1/85.7 ± 7.9 mmHg. At week 12, the change from baseline in mean 24-hour ambulatory BP (± standard error of the mean [SEM]) was -21.4 ± 0.8/-12.7 ± 0.5 mmHg (p < 0.0001 versus baseline). At baseline, the mean SeBP (± SD) was 158.2 ± 12.6/92.8 ± 8.6 mmHg and at week 12, the mean SeBP change (± SEM) from baseline (last observation carried forward) was -24.1 ± 1.1/-12.1 ± 0.7 mmHg (p < 0.0001 versus baseline). Proportions of patients achieving mean 24-hour ambulatory BP prespecified study targets were 70.9% (<130/80 mmHg), 48.3% (<125/75 mmHg), and 40.7% (<120/80 mmHg). Cumulatively, 76.8% of patients uptitrated to AML/OM 10/40 mg/day attained an SeBP goal of <140/90 mmHg. The study drug was well tolerated with few adverse events (peripheral edema, 2.2%; dizziness, 1.1%). An AML/OM-based titration regimen effectively reduces BP in patients with hypertension.
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