Punzi Henry, Shojaee Ali, Maa Jen-Fue
Punzi Medical Center, 1932 Walnut Plaza, Carrollton, TX 75006, USA.
Ther Adv Cardiovasc Dis. 2012 Aug;6(4):149-61. doi: 10.1177/1753944712452190. Epub 2012 Aug 1.
This is a prespecified subgroup analysis in Hispanic and non-Hispanic patients of a study that evaluated blood pressure (BP) control with fixed-dose amlodipine/olmesartan medoxomil (AML/OM)-based therapy in patients whose condition was uncontrolled on prior monotherapy.
In this prospective, open-label, dose-titration study, patients with uncontrolled BP after at least 1 month of antihypertensive monotherapy were switched to fixed-dose AML/OM 5/20 mg. Patients were uptitrated to AML/OM 5/40 and 10/40 mg, with uptitration to AML/OM + hydrochlorothiazide 10/40 + 12.5 mg and 10/40 + 25 mg to achieve target BP. The primary efficacy endpoint was the cumulative proportion of patients achieving seated cuff systolic BP (SeSBP) less than 140 mmHg (<130 mmHg in patients with diabetes mellitus) at 12 weeks. Secondary endpoints included SeBP goal rates, ambulatory BP (ABP) target rates, and mean change from baseline in seated cuff BP (SeBP) and ABP at weeks 12 and 20.
Mean baseline BP was similar in Hispanics (153.6/92.8 mmHg; n = 105) and non-Hispanics (153.7/91.8 mmHg; n = 894). At 12 weeks, 72.0% of Hispanics and 76.3% of non-Hispanics achieved the primary endpoint. At week 12, goal rates for cumulative SeBP (<140/90 mmHg or <130/80 mmHg in patients with diabetes) were 69.0% and 71.5% in Hispanic and non-Hispanic patients, respectively. Mean change in SeBP in Hispanics ranged from -15.3/-7.3 mmHg for AML/OM 5/20 mg to -23.2/-13.8 mmHg for AML/OM 10/40 mg + hydrochlorothiazide 25 mg, and in non-Hispanics from -14.1/-7.8 mmHg to -25.4/-13.7 mmHg (all p < 0.0001 versus baseline). A majority of patients achieved mean 24 h, daytime, and nighttime ABP targets in both subgroups. Greater proportions of Hispanics achieved ABP targets versus non-Hispanics at week 12; however, this trend was reversed at week 20. Treatment was well tolerated.
Switching to a fixed-dose combination of AML/OM ± hydrochlorothiazide provided significant BP lowering and effectively controlled BP in a large proportion of Hispanic and non-Hispanic patients with hypertension uncontrolled on previous monotherapy.
这是一项在西班牙裔和非西班牙裔患者中进行的预先指定的亚组分析，该研究评估了在先前单一疗法控制不佳的患者中，使用固定剂量氨氯地平/奥美沙坦酯（AML/OM）为基础的疗法对血压（BP）的控制情况。
在这项前瞻性、开放标签、剂量滴定研究中，经过至少1个月抗高血压单一疗法后血压仍未得到控制的患者被换用固定剂量的AML/OM 5/20 mg。患者被滴定至AML/OM 5/40和10/40 mg，再滴定至AML/OM + 氢氯噻嗪10/40 + 12.5 mg和10/40 + 25 mg以达到目标血压。主要疗效终点是在12周时达到坐位袖带收缩压（SeSBP）低于140 mmHg（糖尿病患者<130 mmHg）的患者的累积比例。次要终点包括SeBP达标率、动态血压（ABP）达标率，以及在第12周和第20周时坐位袖带血压（SeBP）和ABP相对于基线的平均变化。
西班牙裔患者（153.6/92.8 mmHg；n = 105）和非西班牙裔患者（153.7/91.8 mmHg；n = 894）的平均基线血压相似。在12周时，72.0%的西班牙裔患者和76.3%的非西班牙裔患者达到了主要终点。在第12周时，西班牙裔和非西班牙裔患者累积SeBP（<140/90 mmHg或糖尿病患者<130/80 mmHg）的达标率分别为69.0%和71.5%。西班牙裔患者中，SeBP的平均变化范围从AML/OM 5/20 mg时的-15.3/-7.3 mmHg到AML/OM 10/40 mg + 氢氯噻嗪25 mg时的-23.2/-13.8 mmHg，非西班牙裔患者则从-14.1/-7.8 mmHg到-25.4/-13.7 mmHg（与基线相比，所有p < 0.0001）。两个亚组中的大多数患者均达到了24小时平均、日间和夜间ABP目标。在第12周时，达到ABP目标的西班牙裔患者比例高于非西班牙裔患者；然而，这一趋势在第20周时逆转。治疗耐受性良好。
换用固定剂量的AML/OM ± 氢氯噻嗪组合可显著降低血压，并有效控制了大部分先前单一疗法控制不佳的西班牙裔和非西班牙裔高血压患者的血压。
