武田在日本推出高血压药物Zacras和Azilva

武田（Tkeda）6月18日宣布，在日本推出高血压药物Zacras复方片和Azilva片（azilsartan，阿齐沙坦，10mg）。Zacras复方片是阿齐沙坦（azilsartan）和氨氯地平（amlodipine）固定剂量组合（FDC）复方药，该药为每日一次的口服片剂，有2种剂量：Zacras复方片LD（azilsartan/amlodipine，20mg/2.5mg）和Zacras复方片HD（20mg/5mg）。Azilva（10mg）提供了一种新的剂量强度，目前已上市的剂量为Azilva（20mg）和Azilva（40mg）。

阿齐沙坦（zilsartan）是一种血管紧张素II受体阻滞剂（ARB），通过阻断血管升压激素血管紧张素II发挥降血压作用；氨氯地平（amlodipine）是一种钙通道阻滞剂（CCB），通过抑制血管平滑肌细胞内向钙通道发挥降血压作用，导致外周动脉血管舒张。

英文原文：Zacras® Combination Tablets LD and Zacras® Combination Tablets HD, Fixed-Dose Combination of Azilsartan and Amlodipine, and Azilva® Tablets 10mg, Treatment for Hypertension, are Now Available in Japan

Osaka, Japan, June 18, 2014—Takeda Pharmaceutical announced that it has launched Zacras combination tablets, a fixed-dose combination (FDC) of azilsartan and amlodipine besylate hydrochloride, and Azilva tablets 10mg (azilsartan) for the treatment of hypertension in Japan.

Zacras is a once-daily, oral tablet in two strengths: Zacras Combination Tablets LD (20mg azilsartan / 2.5mg amlodipine) and Zacras Combination Tablets HD (20mg azilsartan / 5mg). Avilza 10 mg tablets adds another dosage strength to the already available Azilva 20 mg and 40 mg. Azilsartan is a angiotensin II receptor blocker (ARB) that works to lower blood pressure by blocking the vasopressor hormone angiotensin II. Amlodipine is a calcium channel blocker with a hypotensive action that inhibits inward calcium ion channels in the vascular smooth-muscle cells. This results in peripheral arteriolar vasodilation.

The company reports that in a Phase III clinical trial, Zacras’ anti-hypertensive effect in diastolic blood pressure was statistically significant versus monotherapy with either azilsartan or amlodipine. The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH2014), issued by the Japanese Society of Hypertension, recommends the ARB-CCB combination treatment for hypertension based on safety and efficacy. Takeda points out that the simpler prescription of fixed dose combination also leads to improved blood pressure control. NHI prices of the FDC drugs are also comparatively lower than the sum of two individual drugs.

Masato Iwasaki, Director and Senior Vice President, Pharmaceutical Marketing Division of Takeda, said, “The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH2014) report that there are approximately 43 million hypertensive patients in Japan, and of all individuals on anti-hypertensive medication, only approximately 30% of men and 40% of women have achieved their target blood pressure 2 levels. We believe that Zacras, having strong and persistent hypotensive effects, may offer a new… optimal treatment option that fit the clinical conditions of individual patients.”