Department of Clinical Pharmacology, Orange County Research Center, Tustin, CA 92780, USA.
Adv Ther. 2012 Jun;29(6):508-23. doi: 10.1007/s12325-012-0030-z. Epub 2012 Jul 4.
While monotherapy is often recommended as initial treatment, most patients require dose escalation and add-on agents to achieve their blood pressure (BP) goal. This secondary analysis evaluated the efficacy and safety of initiating patients on a regimen of fixed-dose amlodipine (AML)/olmesartan medoxomil (OM) ± hydrochlorothiazide (HCTZ) who were uncontrolled on prior monotherapy with a calcium channel blocker (CCB) or angiotensin II receptor blocker (ARB).
Patients uncontrolled on prior monotherapy with CCB or ARB therapy were initiated on AML/OM 5/20 mg and up-titrated every 4 weeks to AML/OM 5/40 mg, AML/OM 10/40 mg, AML/OM 10/40 + HCTZ 12.5 mg, and AML/OM 10/40 + HCTZ 25 mg. Patients were up-titrated to a higher AML/OM dose if mean seated cuff BP (SeBP) was ≥120/70 mmHg, and up-titrated to any HCTZ dose if mean SeBP was ≥125/75 mmHg. The primary efficacy endpoint was the cumulative proportion of patients achieving a seated cuff systolic BP (SeSBP) goal of <140 mmHg (<130 mmHg for patients with diabetes) after 12 weeks. Secondary endpoints included mean change from baseline in SeBP and ambulatory BP, ambulatory BP target achievement, and safety.
For the prior CCB (n = 118; baseline SeBP: 153.4/91.5 mmHg) and ARB (n = 237; 154.6/92.6 mmHg) groups, SeSBP goal achievement after 12 weeks was 72.7% and 76.9%, respectively. Mean changes (± SE) from baseline in SeBP were dose proportional for prior CCB and ARB patients, ranging from -9.9 (± 1.25)/-5.8 (± 0.83) mmHg and -13.9 (± 0.79)/-7.6 (± 0.47) mmHg at the AML/OM 5/20 mg dose, respectively, to -21.8 (± 1.68)/-11.6 (±.12) mmHg and -26.2 (± 1.31)/-15.0 (± 0.86) mmHg at the AML/OM 10/40 mg + HCTZ 25 mg dose (P < 0.0001 for all).
An AML/OM-based titration regimen was efficacious in achieving BP goal in patients uncontrolled on prior monotherapy with a CCB or ARB.
虽然通常推荐单药治疗作为初始治疗，但大多数患者需要增加剂量并添加附加药物才能达到其血压（BP）目标。这项二次分析评估了起始患者使用固定剂量氨氯地平（AML）/奥美沙坦酯（OM）±氢氯噻嗪（HCTZ）治疗方案的疗效和安全性，这些患者先前使用钙通道阻滞剂（CCB）或血管紧张素 II 受体阻滞剂（ARB）单药治疗未得到控制。
先前使用 CCB 或 ARB 单药治疗未得到控制的患者开始使用 AML/OM 5/20mg，并每 4 周递增至 AML/OM 5/40mg、AML/OM 10/40mg、AML/OM 10/40+ HCTZ 12.5mg 和 AML/OM 10/40+HCTZ 25mg。如果平均坐位袖带血压（SeBP）≥120/70mmHg，则将患者递增至更高的 AML/OM 剂量，如果平均 SeBP≥125/75mmHg，则递增至任何 HCTZ 剂量。主要疗效终点是在 12 周后达到坐位袖带收缩压（SeSBP）<140mmHg（糖尿病患者<130mmHg）的患者累积比例。次要终点包括基线 SeBP 和动态血压的平均变化、动态血压目标达标情况和安全性。
对于先前的 CCB（n=118；基线 SeBP：153.4/91.5mmHg）和 ARB（n=237；154.6/92.6mmHg）组，分别有 72.7%和 76.9%的患者在 12 周后达到 SeSBP 目标。对于先前的 CCB 和 ARB 患者，从 AML/OM 5/20mg 剂量开始，SeBP 的平均变化（± SE）与剂量呈比例，分别为-9.9（±1.25）/-5.8（±0.83）mmHg 和-13.9（±0.79）/-7.6（±0.47）mmHg，至 AML/OM 10/40mg+HCTZ 25mg 剂量时为-21.8（±1.68）/-11.6（±0.12）mmHg 和-26.2（±1.31）/-15.0（±0.86）mmHg（均<0.0001）。
基于 AML/OM 的滴定方案在先前使用 CCB 或 ARB 单药治疗未得到控制的患者中实现了血压目标，是有效的。
