Edarbi获准用于治疗成人高血压

ST LOUIS (MD Consult) - On February 25, 2011, Takeda Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved Edarbi (azilsartan medoxomil) for the treatment of hypertension in adults. Edarbi is an angiotensin II receptor blocker. The drug is approved as a once-daily oral therapy for use alone or in combination with other antihypertensive agents.

The safety and efficacy of Edarbi were studied as a once-daily oral therapy, as well as in combination with chlorthalidone and amlodipine. Results from phase 3 clinical trials showed that Edarbi successfully met the primary end point (ie, a change in 24-hour mean systolic blood pressure [SBP] as measured by ambulatory blood pressure monitoring) with statistical significance of lowering blood pressure compared with placebo and with head-to-head active comparators. Specifically, results from one study showed that the use of Edarbi at doses of 80 mg/d and 40 mg/d lowered 24-hour mean SBP by 14.3 mm Hg and 13.2 mm Hg from baseline, respectively. The blood pressure reductions shown with the use of Edarbi (80 mg/d) were statistically superior to those with the use of the active comparators valsartan 320 mg/d (–10.0 mm Hg) and olmesartan medoxomil 40 mg/d (–11.7 mm Hg). Similar results were observed in all 3 comparator studies.

The most common adverse reaction observed during clinical trials was diarrhea (2%). The use of Edarbi should be avoided in pregnant women because drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women during the second and third trimester.

Edarbi will be available in 80- and 40-mg doses, with the recommended dose set at 80 mg once daily. In patients with an activated renin-angiotensin system, such as persons with volume- and/or salt-depletion (eg, those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with Edarbi. Volume or sodium depletion should be corrected before the administration of Edarbi, and dosing in such patients should start at 40 mg/d.

圣路易斯(MD Consult)——2011年2月25日，日本武田制药公司宣布，美国食品药品管理局(FDA)已经批准血管紧张素Ⅱ受体阻滞剂Edarbi(阿齐沙坦酯)用于治疗成人高血压。该药为口服用药，每日服药1次，既可单用，亦可与其他降压药联用。

有研究探讨了Edarbi每日1次口服用药及其与氯塞酮和氨氯地平联用时的安全性和疗效。Ⅲ期临床试验的结果显示，Edarbi成功达到主要研究终点，即24小时动态血压监测显示平均收缩压(SBP)改变，并且与安慰剂和其他活性药物相比，该药可降低血压且差异达到统计学意义。具体而言，一项研究的结果表明，Edarbi 80 mg/d 和40 mg/d可分别使24 小时平均SBP相对于基线下降14.3 mmHg和13.2 mmHg。Edarbi (80 mg/d)的降压疗效在统计学上优于阳性对照缬沙坦320 mg/d(降幅为10.0mm Hg)和奥美沙坦酯40 mg/d (降幅为11.7 mmHg)。3项相关活性药物的“头对头”试验也都观察到了相似的结果。

在临床试验期间观察到的最常见的不良反应是腹泻(2%)。由于Edarbi直接作用于肾素-血管紧张素系统，若孕妇在孕中期和孕晚期使用该药，可引起胎儿和新生儿患病和死亡，故孕妇应该禁用此药。

Edarbi将以80 mg和 40 mg两种剂型上市，推荐剂量是80 mg、每日1次。对于肾素-血管紧张素系统已激活的患者，比如伴有低血容量和(或)低钠血症的患者(如使用大剂量利尿剂治疗的患者)，在使用Edarbi后可发生症状性低血压，故在对这类患者使用Edarbi之前应该先纠正低血容量或低钠血症，而且应以40 mg/d作为起始剂量。

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