美国FDA批准上市治疗高血压口服片剂Benicar

Benicar口服片剂，治疗高血压；Forest Laboratories开发生产；2002年4月批准上市。FDA已经批准了Benicar® (olmesartan)——新的血管紧张素转化酶II抑制剂，用来治疗高血压。该药物是由Sankyo Pharma (Parsippany, NJ)研制的。

Benicar可以单独给予，也可以与其它抗高血压药物联合使用，其推荐的初始剂量为20mg/天。研究显示使用该药物剂量可以是舒张压和收缩压都降低，其中使收缩压平均降低15mmHg，而舒张压可以平均降低12mmHg。使用安慰剂的患者其收缩压平均降低5.6mmHg，而舒张压平均降低6.2mmHg。使用Benicar其唯一的副作用是超过1%的患者会发生头昏，比那些接受安慰剂治疗的患者的发生率要高（3%比1%）。

Drug Name: Benicar
The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.
Company: Forest Laboratories
Approval Status: Approved April 2002
Treatment for: Hypertension

General Information
Benicar is an angiotensin II receptor blocker (ARB) approved for the treatment of hypertension. This once-daily oral tablet that may be administered alone or in combination with other antihypertensive agents.
Hypertension, the term used for abnormally high blood pressure, is the most common health problem in the United States. Over 50 million Americans suffer from hypertension, but many are unaware of the problem and remain untreated. Left untreated, it can lead to serious and life-threatening events including stroke and heart attack.

Clinical Results
Approval of Benicar is supported by 7 placebo-controlled studies, with doses ranging from 2.5 to 80 mg, given for six to 12 weeks. The trials included more than 3275 subjects with essential hypertension. All seven studies reported significant reductions in peak and trough levels of diastolic and systolic blood pressure. Response was dose-related, with 20 mg and 40 mg doses inducing the desired effect and doses over 40 mg having little additional effect. The blood pressure lowering effect from using Benicar once-daily was maintained throughout the 24 hour period, with trough-to-peak ratios for systolic and diastolic response between 60 and 80%.

Side Effects
Adverse events associated with the use of Benicar may include (but are not limited to) the following:
• Dizziness

Mechanism of Action
Benicar (olmesartan medoxomil) blocks the vasoconstrictive effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT receptor in vascular smooth muscle.

Additional Information
For additional information on Benicar, please visit www.benicar.com.