Punzi Henry, Neutel Joel M, Kereiakes Dean J, Shojaee Ali, Waverczak William F, Dubiel Robert, Maa Jen-Fue
Trinity Hypertension Research Institute and Metabolic Research Institute, Punzi Medical Center, 1932 Walnut Plaza, Carrollton, TX 75006, USA.
Ther Adv Cardiovasc Dis. 2010 Aug;4(4):209-21. doi: 10.1177/1753944710374745. Epub 2010 Jun 2.
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.
本研究的目的是使用动态血压监测（ABPM）来确定氨氯地平（AML）与奥美沙坦酯（OM）固定剂量组合在24小时给药间隔内的疗效。这项为期12周的达标滴定研究纳入了185例高血压患者。患者最初接受5毫克/天的AML治疗，如果平均坐位血压（SeBP）≥120/80毫米汞柱，则每3周将剂量上调至AML/OM 5/20、5/40和10/40毫克/天。主要疗效终点是通过ABPM评估的第12周时24小时平均收缩压相对于基线的变化。基线时，24小时动态血压平均值（±标准差[SD]）为144.8±11.1/85.7±7.9毫米汞柱。在第12周时，24小时动态血压平均值相对于基线的变化（±平均标准误差[SEM]）为-21.4±0.8/-12.7±0.5毫米汞柱（与基线相比，p<0.0001）。基线时，平均SeBP（±SD）为158.2±12.6/92.8±8.6毫米汞柱，在第12周时，相对于基线（末次观察值结转）的平均SeBP变化（±SEM）为-24.1±1.1/-12.1±0.7毫米汞柱（与基线相比，p<0.0001）。达到24小时动态血压预设研究目标的患者比例分别为70.9%（<130/80毫米汞柱）、48.3%（<125/75毫米汞柱）和40.7%（<120/80毫米汞柱）。累计有76.8%上调至AML/OM 10/40毫克/天的患者实现了SeBP目标<140/90毫米汞柱。研究药物耐受性良好，不良事件较少（外周水肿，2.2%；头晕，1.1%）。基于AML/OM的滴定方案可有效降低高血压患者的血压。
