|
近年；,欧美相继批准了Novartis公司开发的一个由钙通道阻滞剂氨氯地平(amlodipine)、血管紧张素受体阻滞剂缬沙坦(valsartan)和利尿药氢氯噻嗪(hydrochlorothiazide)组成的固定剂量复合片剂Exforge HCT,用于一日1次口服治疗虽在使用该制剂中含有的任两药物联合治疗.
美国FDA批准复方氨氯地平/缬沙坦/氢氯噻嗪片上市
美国FDA批准诺华公司氨氯地平+缬沙坦+氢氯噻嗪片商品复方制剂(amlodipine+valsartan+hydrochlorothiazide，Exforge HCT)上市治疗高血压。本品结合了3种最常处方用药的高血压治疗药：钙通道阻滞剂氨氯地平、血管紧张素受体阻滞剂缬沙坦和利尿药氢氯噻嗪。本品对曾联合使用过这些降压药中的两者但未获得满意疗效的患者来说是一重要的治疗新观点。
大多数高血压患者需要一种以上的抗高血压药来控制血压，少数严重高血压患者需3种或更多的药物来严格控制血压。3种药物结合在1片一日1次的Exforge HCT服用更为方便，有助于更好地控制患者的血压。
临床研究显示:
本品治疗中度至严重高血压[平均坐位舒张压（MSDBP）100 mmHg 而 <120 mmHg，平均坐位收缩压（MSSBP）145 mmHg 而 <200 mmHg]患者有效。在临床研究中，Exforge HCT最大剂量（氨氯地平/缬沙坦/氢氯噻嗪10 mg/320 mg/25 mg）显示较所有2种相同剂量药物联合使用多降低收缩压18％～29％和舒张压19％～32％。Exforge HCT较下述2种药物联合使用多降低收缩压/舒张压分别比缬沙坦/氢氯噻嗪320 mg/25 mg -7.6 mmHg/5.0 mmHg；氨氯地平/缬沙坦10 mg/320 mg -6.2 mmHg/3.3 mmHg；氨氯地平/氢氯噻嗪10 mg/25 mg -8.2 mmHg/5.3 mmHg。对不卧床患者的血压监测显示，Exforge HCT降压疗效可持续24小时。
FDA approves Exforge HCT® - the only high blood pressure treatment to combine three medications in a single pill
Exforge HCT combines in one pill a calcium channel blocker, angiotensin receptor blocker and diuretic (amlodipine, valsartan, hydrochlorothiazide)
In a clinical trial, Exforge HCT demonstrated significantly greater reductions in systolic and diastolic BP, compared to all dual combinations of its components1
Up to 85% of patients may need multiple medications to help control their blood pressure2 and many need three or more1
Exforge HCT can help appropriate patients reach BP goals; offers convenienceand potential cost savings by reducing up to three co-payments to one
Basel, 30 April, 2009 — The US Food and Drug Administration (FDA) has approved Exforge HCT, the only single pill to combine the three most prescribed high blood pressure treatments in their classes in the US3: the calcium channel blocker amlodipine, the angiotensin receptor blocker valsartan, and the diuretic hydrochlorothiazide.
Exforge HCT is an important new option for patients who have tried taking dual combinations of these classes of blood pressure medications without success.
“The majority of people with hypertension will require more than one medication to control their blood pressure and it’s not uncommon for patients with severe hypertension and/or patients requiring stricter blood pressure control to need three or more medications,” said David A. Calhoun, MD, Professor of Medicine, Vascular Biology and Hypertension Program, University of Alabama at Birmingham. “With a
triple combination option, appropriate patients may experience a simpler routine of a convenient, once-daily pill to help them control their high blood pressure.”
Exforge HCT provides proven efficacy in patients with moderate to severe hypertension (MSDBP 100 mmHg and <120 mmHg, MSSBP 145 mmHg and <200 mmHg)1. In a clinical trial, the maximum dose of Exforge HCT (amlodipine/valsartan/hydrochlorothiazide 10 mg/320 mg/25 mg) demonstrated additional reductions of 18-29% in systolic blood pressure and 19-32% in diastolic blood pressure when compared to all dual combinations of its components at the same doses1,4.
The reductions in systolic/diastolic blood pressure with Exforge HCT were 7.6/5.0 mmHg greater than with valsartan/hydrochlorothiazide 320mg/25 mg; 6.2/3.3 mmHg greater than with amlodipine/valsartan 10mg/320 mg; and 8.2/5.3 mmHg greater than with amlodipine/hydrochlorothiazide 10 mg/25 mg4.
These results also include a placebo effect of unknown size. Ambulatory blood pressure monitoring showed that the blood pressure lowering effect of Exforge HCT was maintained throughout the 24-hour period4.
High blood pressure affects approximately 74 million adults in the US and one in four adults worldwide5. If high blood pressure is not treated, it can lead to heart attack and stroke.
Exforge HCT is not indicated for the treatment or prevention of heart attack or
stroke.2/3 Research suggests that up to 85% of patients may need multiple medications2 and many need three or more1 to help control their blood pressure. Patients may find treatment more convenient with one single pill rather than separate pills.
Exforge HCT contains three effective medicines that work in three different ways1. A patient may be switched to the single pill combination Exforge HCT if blood pressure is not adequately controlled on any two of the following anti-hypertensive classes:
calcium channel blockers, angiotensin receptor blockers, and diuretics4.
The full blood pressure lowering effect was achieved two weeks after being on the maximal dose of Exforge HCT.
“This approval of Exforge HCT as the only single blood pressure pill combining the efficacy of three of the most-prescribed treatments in their classes represents a significant milestone toward reducing the burden of unmet need in hypertension,” said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. “Novartis remains confident in the important role of single pill combination medications to help appropriate patients achieve their blood pressure targets, while providing physicians with a range of powerful yet flexible combinations of doses to effectively manage
high blood pressure in different patients.”
Exforge and Exforge HCT will be offered at the same price in the US on a doseequivalent basis, essentially providing the added diuretic in Exforge HCT at no additionalcost.
Since Exforge HCT combines three medications in a single pill, patients may benefit from reduced insurance co-payments.
 
附件:
200981300535221.png
200981300433119.png
200981300424934.pdf
---------------------------------------------------------------
注：以下产品不同规格和不同价格，购买以咨询为准！
---------------------------------------------------------------
产地国家: 欧洲共同体国家
原产地英文商品名:
EXFORGE HCT (5-160-25)mg/tablet 28tablets/bottle
原产地英文药品名:
AMLODIPINE BESYLATE/VALSARTAN/HYDROCHLOROTHIAZIDE
中文参考商品译名:
EXFORGE HCT (5-160-25)毫克/片 28片/瓶
中文参考药品译名:
苯磺酸氨氯地平/缬沙坦/氢氯噻嗪
生产厂家中文参考译名:
诺华
生产厂家英文名:
NOVARTIS
---------------------------------------------------------------
产地国家: 德国
原产地英文商品名:
EXFORGE HCT (5-160-25)mg/tablet 28tablets/bottle
原产地英文药品名:
AMLODIPINE BESYLATE/VALSARTAN/HYDROCHLOROTHIAZIDE
中文参考商品译名:
EXFORGE HCT (5-160-25)毫克/片 98片/瓶
中文参考药品译名:
苯磺酸氨氯地平/缬沙坦/氢氯噻嗪
生产厂家中文参考译名:
诺华
生产厂家英文名:
NOVARTIS
--------------------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
EXFORGE HCT 10-160-25 MG/ TAB 30tablets/bottle
原产地英文药品名:
AMLODIPINE BESYLATE 10MG / VALSARTAN 160MG / HYDROCHLOROTHIAZIDE 25MG
中文参考商品译名:
EXFORGE HCT 10-160-25毫克/片 30片/瓶
中文参考药品译名:
苯磺酸氨氯地平10毫克 / 缬沙坦160毫克 / 氢氯噻嗪 25毫克
生产厂家中文参考译名:
诺华
生产厂家英文名:
NOVARTIS
--------------------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
EXFORGE HCT 10-160-12.5 MG/ TAB 30tablets/bottle
原产地英文药品名:
AMLODIPINE BESYLATE 10MG / VALSARTAN 160MG / HYDROCHLOROTHIAZIDE 12.5MG
中文参考商品译名:
EXFORGE HCT 10-160-12.5毫克/片 30片/瓶
中文参考药品译名:
苯磺酸氨氯地平10毫克 / 缬沙坦160毫克 / 氢氯噻嗪 12.5毫克
生产厂家中文参考译名:
诺华
生产厂家英文名:
NOVARTIS
---------------------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
EXFORGE HCT 5-160-25 MG/ TAB 30tablets/bottle
原产地英文药品名:
AMLODIPINE BESYLATE 5MG / VALSARTAN 160MG / HYDROCHLOROTHIAZIDE 25MG
中文参考商品译名:
EXFORGE HCT 5-160-25毫克/片 30片/瓶
中文参考药品译名:
苯磺酸氨氯地平5毫克 / 缬沙坦160毫克 / 氢氯噻嗪 25毫克
生产厂家中文参考译名:
诺华
生产厂家英文名:
NOVARTIS
-------------------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
EXFORGE HCT 5-160-12.5 MG/ TAB 30tablets/bottle
原产地英文药品名:
AMLODIPINE BESYLATE 5MG / VALSARTAN 160MG / HYDROCHLOROTHIAZIDE 12.5MG
中文参考商品译名:
EXFORGE HCT 5-160-12.5毫克/片 30片/瓶
中文参考药品译名:
苯磺酸氨氯地平5毫克 / 缬沙坦160毫克 / 氢氯噻嗪 12.5毫克
生产厂家中文参考译名:
诺华
生产厂家英文名:
NOVARTIS
|
