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).
A single-blind, run-in, randomized, double-blind, parallel-group, placebo-controlled comparison trial was conducted to assess the safety and efficacy of low-dose amlodipine 2.5 mg daily, low-dose benazepril 10 mg daily, and the combination of the two drugs at the same doses used once daily in patients (n = 401) with mild to moderate (stages I and II) systemic hypertension. Both monotherapy regimens were shown to significantly reduce both systolic and diastolic blood pressure compared with baseline placebo values, and the combination regimen was shown to be superior in lowering systolic and diastolic blood pressure when compared with either of the monotherapy regimens. The combination therapy also resulted in a greater percentage of patients having successful clinical response in mean sitting diastolic blood pressure. The amlodipine and benazepril regimen was also shown to be associated with a similar incidence of adverse experiences as the active monotherapy or placebo regimens, although the group given combination therapy appeared to have a lower incidence of edema than the group given amlodipine alone. Low-dose amlodipine (2.5 mg) plus benazepril (10 mg) provides greater blood-pressure-lowering efficacy than either monotherapy, and has an excellent safety profile.
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