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使用24小时动态血压监测评估血压控制情况:奥美沙坦酯与苯磺酸氨氯地平的比较

Use of 24-h ambulatory blood pressure monitoring to assess blood pressure control: a comparison of olmesartan medoxomil and amlodipine besylate.

作者信息

Chrysant Steven G, Marbury Thomas C, Silfani Tonous N

机构信息

Oklahoma Cardiovascular and Hypertension and the University of Oklahoma School of Medicine, Oklahoma City 73132, USA.

出版信息

Blood Press Monit. 2006 Jun;11(3):135-41. doi: 10.1097/01.mbp.0000209087.40117.b3.

Abstract

OBJECTIVE

Olmesartan medoxomil is an angiotensin II receptor blocker with similar antihypertensive efficacy as the calcium channel blocker amlodipine besylate in patients with mild-to-moderate hypertension. In addition to a drug's ability to lower blood pressure, the effectiveness of the agent in enabling patients to achieve specific blood pressure targets is an important clinical consideration. This secondary analysis of a randomized, double-blind study compared the efficacy of olmesartan medoxomil with that of amlodipine besylate in achieving ambulatory blood pressure goals among patients with mild-to-moderate hypertension.

METHODS

Following a 4-week placebo run-in, 440 study participants aged >or=18 years were randomized to olmesartan medoxomil (20 mg/day), amlodipine besylate (5 mg/day), or placebo for 8 weeks. The proportion of participants achieving specific systolic and diastolic ambulatory blood pressure goal levels was calculated by dividing the number of participants who had achieved a particular blood pressure goal by the total number of patients in the intent-to-treat population.

RESULTS

After 8 weeks of treatment, a mean 24-h ambulatory blood pressure of <130/80 or <130/85 mmHg was achieved by significantly more participants in the olmesartan medoxomil group (18.1 and 30.4%, respectively) than in the amlodipine besylate (7.0 and 14.0%, respectively) or placebo (1.9% for both) groups. The target daytime ambulatory blood pressure of <135/85 mmHg was achieved by more participants in the olmesartan medoxomil group than in the amlodipine besylate group (15.8 vs. 5.8%, respectively; P<0.01).

CONCLUSION

In a previous publication of the same study, we demonstrated that starting doses of olmesartan medoxomil and amlodipine besylate produced similar mean reductions in blood pressure. In this subanalysis of the blood pressure data from that primary publication, however, olmesartan medoxomil therapy was shown to result in a greater proportion of patients achieving specific ambulatory blood pressure goals than therapy with amlodipine besylate. As blood pressure goal attainment may be of more direct clinical relevance than numerical blood pressure lowering, the achievement of blood pressure goals should be a key efficacy parameter assessed in clinical trials of antihypertensive medications.

摘要

目的

奥美沙坦酯是一种血管紧张素II受体阻滞剂,在轻至中度高血压患者中,其降压疗效与钙通道阻滞剂苯磺酸氨氯地平相似。除了药物降低血压的能力外,药物使患者达到特定血压目标的有效性也是一项重要的临床考量因素。这项对一项随机双盲研究的二次分析,比较了奥美沙坦酯与苯磺酸氨氯地平在轻至中度高血压患者中实现动态血压目标的疗效。

方法

在为期4周的安慰剂导入期后,440名年龄≥18岁的研究参与者被随机分为奥美沙坦酯组(20毫克/天)、苯磺酸氨氯地平组(5毫克/天)或安慰剂组,为期8周。通过将达到特定血压目标的参与者人数除以意向性治疗人群中的患者总数,计算达到特定收缩压和舒张压动态血压目标水平的参与者比例。

结果

治疗8周后,奥美沙坦酯组中达到24小时平均动态血压<130/80或<130/85 mmHg的参与者比例(分别为18.1%和30.4%)显著高于苯磺酸氨氯地平组(分别为7.0%和14.0%)或安慰剂组(两者均为1.9%)。奥美沙坦酯组达到目标日间动态血压<135/85 mmHg的参与者比苯磺酸氨氯地平组更多(分别为15.8%对5.8%;P<0.01)。

结论

在同一研究的先前出版物中,我们证明奥美沙坦酯和苯磺酸氨氯地平的起始剂量产生了相似的平均血压降低幅度。然而,在对该主要出版物的血压数据进行的此次亚组分析中,与苯磺酸氨氯地平治疗相比,奥美沙坦酯治疗显示有更大比例的患者实现了特定的动态血压目标。由于实现血压目标可能比单纯降低血压数值具有更直接的临床相关性,因此实现血压目标应是抗高血压药物临床试验中评估的关键疗效参数。

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