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【drug-news】FDA批准武田制药北美公司的Edarbi治疗
FDA NEWS RELEASE
For Immediate Release: February 25, 2011
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves Edarbi to treat high blood pressure
The U.S. Food and Drug Administration today approved Edarbi tablets (azilsartan medoxomil) to treat high blood pressure (hypertension) in adults.
Data from clinical studies showed Edarbi to be more effective in lowering 24-hour blood pressure compared with two other FDA-approved hypertension drugs, Diovan (valsartan) and Benicar (olmesartan).
“High blood pressure is often called the 'silent killer' because it usually has no symptoms until it causes damage to the body,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Drug Products in the FDA’s Center for Drug Evaluation and Research. “High blood pressure remains inadequately controlled in many people diagnosed with the condition, so having a variety of treatment options is important.”
Edarbi will be available in 80 milligram and 40 mg doses, with the recommended dose set at 80 mg once daily. The 40 mg dose will be available for patients who are treated with high-dose diuretics taken to reduce salt in the body.
Blood pressure is the force of blood pushing against the walls of the arteries as the heart pumps. If blood pressure rises and stays high over time, it can damage the body in many ways. Nearly 1 in 3 adults in the United States has high blood pressure, which increases the risks of stroke, heart failure, heart attack, kidney failure, and death.
Edarbi is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone.
Adverse reactions reported by patients taking Edarbi in clinical trials were similar to those reported by those taking an inactive drug (placebo).
Edarbi has a boxed warning that says the use of the drug should be avoided in pregnant women because use of the drug during the second or third trimester can cause injury and even death in the developing fetus. If a woman becomes pregnant while using the drug, it should be discontinued as soon as possible.
Edarbi is made by Takeda Pharmaceutical North America of Deerfield, Ill. 认领，48h内完成 FDA approves Edarbi to treat high blood pressure
FDA批准Edarbi用于高血压的治疗
The U.S. Food and Drug Administration today approved Edarbi tablets (azilsartan medoxomil) to treat high blood pressure (hypertension) in adults.
美国食品药品监督管理局（FDA）与今天（美国时间2011年2月25日）批准Edarbi片（阿齐沙坦酯）用于成人高血压的治疗。
Data from clinical studies showed Edarbi to be more effective in lowering 24-hour blood pressure compared with two other FDA-approved hypertension drugs, Diovan (valsartan) and Benicar (olmesartan).
临床数据显示Edarbi与FDA已经批准的用于高血压治疗的两种药物代文（缬沙坦）和Benicar（奥美沙坦）相比，在降低24小时血压方面效果更佳。
“High blood pressure is often called the 'silent killer' because it usually has no symptoms until it causes damage to the body,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Drug Products in the FDA’s Center for Drug Evaluation and Research. “High blood pressure remains inadequately controlled in many people diagnosed with the condition, so having a variety of treatment options is important.”
“高血压常被称作是‘无声的杀手’因为直到对身体造成伤害前，通常都不会有明显的症状”，FDA药品评价与研究中心（CDER）心血管及肾脏药物学部主任Norman Stockbridge医学博士表示，“许多患者确诊为高血压，但仍不能对其进行足够的控制，因此对高血压有多种治疗选项是重要的。”
Edarbi will be available in 80 milligram and 40 mg doses, with the recommended dose set at 80 mg once daily. The 40 mg dose will be available for patients who are treated with high-dose diuretics taken to reduce salt in the body.
Edarbi有80mg和40mg两种规格，推荐剂量定为80mg每日一次，40mg规格用于接受大剂量利尿药治疗以降低体内盐分的患者。
Blood pressure is the force of blood pushing against the walls of the arteries as the heart pumps. If blood pressure rises and stays high over time, it can damage the body in many ways. Nearly 1 in 3 adults in the United States has high blood pressure, which increases the risks of stroke, heart failure, heart attack, kidney failure, and death.
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作者:admin@医学,生命科学 2011-03-05 00:11
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