Triple-Combination Therapy with Olmesartan, Amlodipine, and Hydrochlorothiazide in Black and Non-Black Study Participants with Hypertension The TRINITY Randomized, Double-Blind, 12-Week, Parallel-Group Study
Triple-Combination Therapy with Olmesartan, Amlodipine, and Hydrochlorothiazide in Black and Non-Black Study Participants with Hypertension The TRINITY Randomized, Double-Blind, 12-Week, Parallel-Group Study
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DOI：
10.2165/11634160-000000000-00000
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发表时间：
2012-01-01
影响因子：
3
通讯作者：
Heyrman, Reinilde
中科院分区：
文献类型：
--
作者：
Chrysant, Steven G.;Littlejohn, Thomas, III;Heyrman, Reinilde
背景资料：虽然黑人患者对高血压的认识有所增加，但血压（BP）经常得不到充分的控制。目的：Trinity研究中预先规定的亚组分析评价了奥美沙坦酯（OM）40 mg、阿苯磺酸盐（AML）10 mg、和氢氯噻嗪（HCTZ）25 mg三联治疗与黑人和非黑人中的组分双联治疗相比研究设计：Trinity是一项为期12周的随机、双盲、平行组评估。首例患者于2008年5月入组，末例患者于2009年2月完成研究。该研究包括接受抗高血压治疗的参与者的3周洗脱期和12周双盲治疗期。对于治疗阶段，所有研究受试者按年龄、人种和糖尿病状态分层，并随机分配至最终治疗分配的治疗序列，从第4周至第12周接受治疗（OM 40 mg/AML 10 mg/HCTZ 25 mg、OM 40 mg/AML 10 mg、OM 40 mg/HCTZ 25 mg或AM L 10 mg/HCTZ 25 mg）。在双盲治疗期的前2周，所有受试者均接受双联治疗或安慰剂治疗。被分配到双重组合治疗的参与者继续治疗直到第4周，并且接受安慰剂的参与者在第2周转换为接受双重组合治疗之一直到第4周。在第4周，参与者继续接受双联治疗或随机接受三联治疗，直到第12周。设置：美国和波多黎各的317个临床中心被纳入研究。符合随机分组标准的研究参与者（N=2492）年龄≥ 18岁，平均坐位血压（SeBP）≥ 140/100 mmHg或≥ 160/90 mmHg干预：干预是双重或三重联合降压治疗：OM 40 mg/AML 10 mg/HCTZ 25 mg，OM 40 mg/AML 10 mg，OM 40 mg/HCTZ 25 mg或AML 10 mg/HCTZ 25 mg。主要结局指标：主要有效性变量为从基线至第12周最小二乘（LS）平均坐位舒张压（SeDBP）的变化。次要疗效变量包括坐位收缩压（SeSBP）的LS均值变化、研究参与者达到血压目标的百分比和安全性参数。结果：在黑人和非黑人参与者中，三联治疗导致SeDBP和SeSBP显著和相似的平均降低（p
Background: Although awareness of hypertension in Black patients has increased, blood pressure (BP) is frequently inadequately controlled.Objective: This prespecified subgroup analysis of the TRINITY study evaluated the efficacy and safety of olmesartan medoxomil (OM) 40 mg, amlodipine besylate (AML) 10 mg, and hydrochlorothiazide (HCTZ) 25 mg triple-combination treatment compared with the component dual-combination treatments in Black and non-Black study participants.Study Design: TRINITY was a 12-week, randomized, double-blind, parallel-group evaluation. The first patient was enrolled in May 2008 and the last patient completed the study in February 2009. The study consisted of a 3-week washout period for participants receiving antihypertensive therapy and a 12-week double-blind treatment period. For the treatment phase, all study participants were stratified by age, race, and diabetes mellitus status and randomized to a treatment sequence that led to their final treatment assignment, which they received from weeks 4 to 12 (OM 40 mg/AML 10 mg/HCTZ 25 mg, OM 40 mg/AML 10 mg, OM 40 mg/HCTZ 25 mg, or AM L 10 mg/HCTZ 25 mg). In the first 2 weeks of the double-blind treatment period, all participants received either dual-combination treatment or placebo. Participants assigned to dual-combination treatment continued treatment until week 4, and participants receiving placebo were switched at week 2 to receive one of the dual-combination treatments until week 4. At week 4, participants either continued dual-combination treatment or randomly received triple-combination treatment until week 12.Setting: 317 clinical sites in the USA and Puerto Rico were included in the study.Patients: Study participants eligible for randomization (N=2492) were >= 18 years of age with mean seated blood pressure (SeBP) >= 140/100 mmHg or >= 160/90 mmHg (off antihypertensive medication).Intervention: The intervention was with dual- or triple-combination antihypertensive treatment: OM 40 mg/AML 10 mg/HCTZ 25 mg, OM 40 mg/AM L 10 mg, OM 40 mg/HCTZ 25 mg, or AML 10 mg/HCTZ 25 mg.Main Outcome Measure: The primary efficacy variable was the change in least squares (LS) mean seated diastolic BP (SeDBP) from baseline to week 12. Secondary efficacy variables included the LS mean change in seated systolic BP (SeSBP), percentage of study participants reaching BP goal, and safety parameters.Results: In both Black and non-Black participants, triple-combination treatment resulted in significant and similar mean reductions in SeDBP and SeSBP (p