Hypertension Unit, Hospital 12 de Octubre, 28041 Madrid, Spain.
Contemp Clin Trials. 2011 Sep;32(5):710-6. doi: 10.1016/j.cct.2011.04.011. Epub 2011 May 14.
To date, few studies have investigated the effects of combined renin-angiotensin system blockade/calcium channel blockade on central aortic blood pressure. The Conduit Artery Function Evaluation (CAFE) sub-study of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) investigated the effects of amlodipine/perindopril and atenolol/bendroflumethiazide on central aortic blood pressure (CABP). Similar brachial blood pressure levels were achieved; however, there was a significant difference, in favor of the amlodipine/perindopril combination, on the effects of CABP. No study has investigated the effects of a combination of an angiotensin receptor blocker/calcium channel blocker compared to those of a calcium channel blocker/angiotensin-converting enzyme inhibitor combination. To confirm and support previous findings, the SEVITENSION study will assess the effects on CABP of treatment with the high dose combination of perindopril plus amlodipine as used in ASCOT-CAFE compared with the high dose combination of olmesartan/amlodipine in patients with moderate-to-severe hypertension uncontrolled on amlodipine monotherapy.
To demonstrate non-inferiority of fixed-dose olmesartan/amlodipine combination therapy compared with the combination of perindopril plus amlodipine on the mean change from baseline in central aortic systolic blood pressure.
A multicenter, double-blind, parallel-group, non-inferiority study comprising a 2-4-week open-label run-in period with amlodipine and a 24-week active treatment period. CABP will be measured by the SphygmoCor® Vx Pulse Wave Velocity System.
720 moderate-to-severe hypertensive patients aged ≥ 40 to ≤ 80 years and ≥ 3 additional risk factors will be enrolled.
Study treatment will comprise orally-administered combination of olmesartan/amlodipine (40/10mg) or perindopril (8 mg) plus amlodipine (10mg), and matching placebos. (EudraCT number: 2009-012966-30; ClinicalTrials.gov identifier: NCT01101009).
迄今为止，很少有研究调查联合肾素-血管紧张素系统阻断/钙通道阻断对中心主动脉血压的影响。 Anglo-Scandinavian 心脏结局试验（ASCOT）的导血管功能评估（CAFE）子研究调查了氨氯地平/培哚普利和阿替洛尔/苯磺酸氨氯地平对中心主动脉血压（CABP）的影响。尽管达到了类似的臂部血压水平，但氨氯地平/培哚普利联合治疗在 CABP 效果方面具有显著优势。没有研究调查血管紧张素受体阻滞剂/钙通道阻滞剂联合治疗与钙通道阻滞剂/血管紧张素转换酶抑制剂联合治疗的效果比较。为了证实和支持以前的发现，SEVITENSION 研究将评估在中度至重度高血压患者中，与氨氯地平单药治疗未控制的患者相比，使用 ASCOT-CAFE 中所用的培哚普利加氨氯地平的高剂量联合治疗对 CABP 的影响，与奥美沙坦/氨氯地平的高剂量联合治疗相比。
证明固定剂量奥美沙坦/氨氯地平联合治疗与培哚普利加氨氯地平联合治疗在中心主动脉收缩压从基线的平均变化方面不劣效。
一项多中心、双盲、平行组、非劣效性研究，包括 2-4 周的氨氯地平开放标签导入期和 24 周的活性治疗期。CABP 将通过 SphygmoCor® Vx 脉搏波速度系统进行测量。
720 名年龄≥40 岁至≤80 岁且≥3 个其他危险因素的中度至重度高血压患者将被纳入研究。
研究治疗将包括口服奥美沙坦/氨氯地平（40/10mg）或培哚普利（8mg）加氨氯地平（10mg）的联合治疗，以及匹配的安慰剂。（EudraCT 编号：2009-012966-30；ClinicalTrials.gov 标识符：NCT01101009）。
