ST LOUIS (MD Consult) - On May 13, 2009, Daiichi Sankyo, Inc, announced that the US Food and Drug Administration (FDA) has approved the combination drug Azor as first-line therapy for patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. Azor is a once-daily, single tablet combination of amlodipine, a calcium channel blocker (CCB), and olmesartan, an angiotensin II receptor blocker (ARB). It is presumed that antihypertensive combination medications like Azor may provide patients with a more convenient option than separate monotherapies by helping to simplify their treatment regimen and decrease overall pill burden.

Azor's approval as a first-line therapy was granted on the basis of data from a pivotal registration trial. Results of this study provided estimates of the probability of patients attaining blood pressure goals with Azor compared with amlodipine or olmesartan therapy alone. The trial used a double-blind design. Patients in the trial were treated for 8 weeks, and those treated with Azor sustained larger mean reductions in seated blood pressure. In addition, more patients treated with Azor achieved their blood pressure goals than those patients receiving monotherapy.

Initial antihypertensive treatment with Azor is not recommended for patients aged ≥75 years or for patients with impaired liver function. Azor may be substituted for its individually titrated components. Azor may also be used to provide additional blood pressure lowering for patients whose pressure is not adequately controlled with amlodipine (or another dihydropyridine CCB) alone or with olmesartan medoxomil (or another ARB) alone.

圣路易斯(MD Consult)——2009年5月13日，Daiichi Sankyo公司宣布，美国食品药品管理局(FDA)已批准复方制剂Azor作为一线治疗药物，用于治疗可能需要多种抗高血压药才能达到目标血压的患者。Azor是氨氯地平(钙通道阻滞剂，CCB)和奥美沙坦(血管紧张素Ⅱ受体阻滞剂，ARB)的复方片剂，每日只需服用1次。 据认为，诸如Azor这样的抗高血压复方制剂有助于简化治疗方案和减少总费用负担，比单药治疗更经济方便。

基于一项关键的注册研究试验，FDA同意批准Azor作为一线治疗药物。该试验中，将Azor与氨氯地平单药治疗或奥美沙坦单药治疗相比，提供达到目标血压患者的估计概率。该试验为双盲设计，患者接受8周治疗。Azor治疗患者的坐位血压平均降低更多。此外，与单药治疗相比，更多的Azor治疗患者达到目标血压。

不建议对≥75岁患者或肝功能损害患者使用Azor进行初始抗高血压治疗。Azor可用于代替其单独滴定成分。经氨氯地平(或另一种二氢吡啶类CCB)单药治疗或奥美沙坦酯(或另一种ARB)单药治疗但血压控制仍不理想者，也可加服Azor，帮助进一步降压。

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