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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。
该药的商品名为“Edarbi”，是血管紧张素Ⅱ受体阻滞剂（ARB）阿齐沙坦酯（azilsartan medoxomil）的一个衍生物。
Edarbi可阻滞血管紧张素II引起的血管收缩，从而使血压下降。
武田制药北美公司首席执行官Shinji Honda表示对该药获批感到非常高兴，他说，“通过该新药的发现、开发和商业化，武田致力于将Edarbi等新药推向市场。Edarbi对高血压患者以及为其提供治疗的医护人员是一个重要的新治疗选择。”
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。
处方信息摘要
这些要点不包括所有需要使用EDARBI安全和有效的信息。查看完整的处方信息EDARBI。
Edarbi（azilsartan沙坦酯）片
美国初始认证：2011年
警告：避免在怀孕期间使用
查看完整的处方信息完整的黑框警示。
•当发现怀孕，尽快停止Edarbi。药物作用于肾素血管紧张素系统可能造成直接伤害和死亡的胎儿。 （5.1）
适应症
Edarbi是血管紧张素Ⅱ受体阻滞剂治疗高血压的表示，无论是单独或与其他抗高血压药物合用。 （1）
剂量和用法
在成人推荐剂量为80毫克每天服用一次。考虑谁与高剂量利尿剂治疗的患者一开始剂量为40毫克。 （2.1）
Edarbi可能是管理或没有食物。 （2.1）
Edarbi可能是管理与其他降压药。 （2.1）
剂型和优势
片剂：40毫克和80毫克。 （3）
禁忌
无
注意事项：
•避免胎儿或新生儿暴露。 （5.1）
•正确的卷或盐耗尽之前，Edarbi管理。 （5.2）
•监察恶化肾功能不全患者的肾功能。 （5.3）
不良反应
在成人中最常见的不良反应是腹泻（2％）。 （6.1） 。
利用在种群
•哺乳母亲：哺乳或停止用药。 （8.3）
•老年患者：血清肌酐异常高值，更可能是患者年龄为75岁或年纪较大的报道。没有比年轻患者的疗效，但更大一些年长者的整体差异的敏感性不能排除。 （8.5）
在与一个激活的肾素血管紧张素系统的病人•按体积或盐消耗，肾素血管紧张素醛固酮系统（RAAS），如azilsartan沙坦酯受体阻滞剂可引起过度低血压。在敏感的病人，如肾动脉狭窄，RAAS系统阻断剂可引起肾功能衰竭（5.2，5.3）。
•儿科：儿童的安全与疗效尚未确立
Edarbi（azilsartan medoxomil ）
Common name: azilsartan ester
Indications: Edarbi angiotensin Ⅱ receptor blocker is the treatment of hypertension, either with other individual ř combination of antihypertensive drugs.
Pregnancy: C level (first semester) and D (second and third period)
Manufacturer: Takeda Pharmaceuticals America
Formula: 40,80 mg tablets
Side effects: diarrhea, hypotension / postural hypotension. Other side effects include nausea, weakness, fatigue, muscle cramps, dizziness, postural dizziness, cough.
Note:
• When pregnancy is detected as soon as possible to stop Edarbi. Those drugs on the renin-angiotensin system can cause direct damage and fetal death.
• Avoid contact with the fetus or the newborn.
* The correct volume or salt depletion before, Edarbi management.
* Monitor renal dysfunction in patients with renal function deterioration.
Deerfield: Takeda Pharmaceutical Company Limited (Takeda) and its wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved for the treatment of hypertension Edarbi (azilsartan medoxomil), or high blood pressure, adults.
Edarbi is the angiotensin Ⅱ receptor blocker (ARB) to reduce by blocking the vasoconstrictor angiotensin Ⅱ and other hormones, contraction of blood pressure in rats. When angiotensin Ⅱ receptor blocker, blood vessels stay relaxed and open, can lower blood pressure. Edarbi was approved as a once-daily alone and with other antihypertensive drugs in combination with oral therapy.
Takeda Global R & D center in April 2010 the U.S. proposed a new drug Edarbi application (NDA). Confidentiality agreement is to support the seven involved in over 5900 cases of controlled phase 3 clinical trials in patients with hypertension. The key phase III studies show that the Edarbi (80 mg / day) was statistically superior to placebo and the highest approved two drugs commonly used ARB, olmesartan medoxomil (40 mg / day) and valsartan (320 mg / day), dose reduction, outpatient and 24-hour mean blood pressure measurements.
"We are pleased to build on the cardiovascular and Edarbi treatment in the United States ratified the global expertise, said:" Honda President and CEO Shinji Takeda Pharmaceuticals North America. "Through the discovery, development and commercialization of new medicines, Takeda is committed to the market as Edarbi therapy. Edarbi is an important hypertension and health care workers who put their new treatment option."
The safety and efficacy were studied Edarbi once daily oral treatment, as well as chlorthalidone and amlodipine combination. The results from the Phase III clinical trials that successfully met Edarbi lower blood pressure than the statistical significance of the primary endpoint of 24-hour mean systolic blood pressure (SBP) measurement of changes in ambulatory blood pressure monitoring, placebo and active head to head comparison.
Specifically, results from a study in the 80 mg / day and 40 mg / day to 24 hours average 14.3 mm Hg and 13.2 mm Hg baseline, respectively, systolic blood pressure Edarbi. On Edarbi (80 mg / day) reduced blood pressure was statistically more active than valsartan 320 mg / day (-10.0 mm Hg), and olmesartan medoxomil 40 mg / day (-11.7 mm Hg). Similar results were compared in all three studies. In adults the most common adverse reactions were diarrhea (2%).
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