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【drug-news】FDA批准资料胸痛的新药

FDA Approves New Treatment for Chest Pain

The Food and Drug Administration (FDA) announced today the approval of Ranexa (ranolazine), a new drug for the treatment of chronic angina. Ranexa, a new molecular entity (NME), is the first drug approved to treat chronic angina in over ten years. Although several pharmacological activities of ranolazine have been described, the precise way the drug works is not fully understood. Because Ranexa affects electrical conduction in the heart (prolong the QT interval), it should only be used by patients who have not responded to other anti-anginal (long-acting nitrates, calcium channel blockers and beta blockers) drugs.

Chronic angina is characterized by episodes of chest pain, pressure, or discomfort that occur during exercise because the heart muscle is not getting enough oxygen. The most common cause of angina is coronary heart disease, in which the coronary arteries that supply the heart with oxygen–rich blood become blocked with plaque deposits. According to the American Heart Association, approximately 6.8 million Americans are diagnosed with angina every year. While many of these patients respond to other treatments, including surgery and other approved drugs, some remain with angina despite receiving these treatments. Acute attacks of angina are treated with nitroglycerin placed under the tongue whereas treatments for chronic angina are given to increase the amount of exercise a person can do before angina occurs. This is usually tested by showing that people with angina can exercise longer on a treadmill or bicycle when they take the drug.

"Chronic angina limits people's activities," said Dr. Steven Galson, MD, Director of FDA's Center for Drug Evaluation and Research. "The approval of Ranexa provides a new treatment option for Americans who continue to suffer symptoms of angina despite using other angina drugs."

Ranexa was studied in patients with chronic angina who still had symptoms despite being treated with other anti-anginal drugs. Two clinical trials, ERICA (Efficacy of Ranolazine in Chronic Angina) and CARISA (Combination Assessment of Ranolazine In Stable Angina) were conducted. In ERICA, 565 patients who were experiencing about 4.5 angina attacks per week while taking a full dose of a calcium channel blocker were randomized to Ranexa or placebo for 6 weeks. Patients receiving Ranexa had a reduction in angina attacks of about 1 attack per week, compared with those in the placebo group.

In CARISA, 823 patients on either a calcium channel blocker or beta blocker (atenolol) were randomized to Ranexa or placebo and followed for 12 weeks using a formal exercise treadmill test. Patients in the Ranexa group had a mean exercise improvement similar to that seen with other anti-anginal therapies.

In both studies, Ranexa appeared to be less effective in women than in men.

In clinical studies, common side effects included dizziness, headache, constipation and nausea.

Ranexa is manufactured by CV Therapeutics, Inc. in Palo Alto, California. 认领了! FDA批准胸痛新疗法
食品与药品管理局(FDA)今天宣布批准Ranexa(雷诺嗪)作为治疗慢性心绞痛的新药。新式分子药物(NME)Ranexa是近十多年来第一个被批准用于治疗心绞痛的药物。尽管已经说明了雷诺嗪的一些药理活性,但是该药的确切作用机制仍未完全了解。由于Ranexa影响心脏的电位传导(延长QT间期),所以它仅用于对其它抗心绞痛药(长效硝酸酯类、钙通道阻滞剂和β受体阻断剂)无反应的患者。
慢性心绞痛的特征是运动期间出现阵发性胸痛、压迫感或者感觉不适,这是由于心肌没有得到足够的氧。通常心绞痛的起因是冠状动脉心脏病。冠状动脉心脏病是由于供给心脏富氧血的冠状动脉被斑块沉积物堵塞引起的。
根据美国心脏病协会的调查,每年大概有680万美国人被诊断患有心绞痛。当他们中很多患者对其它疗法包括手术和其它被批准的药物产生反应时,而另外一些人尽管接受这些治疗却仍未治愈。心绞痛急性发作给予舌下含服硝酸甘油治疗,然而慢性心绞痛的治疗也可以增加患者在心绞痛发作前的运动量。这通常可以通过心绞痛患者服药期间在踏车或自行车上的运动时间较久来验证。
“慢性心绞痛限制了人们的活动,”药品评价与研究中心主任、医学博士史蒂文•格尔森说,“Ranexa的批准为服用其它心绞痛药但仍遭受心绞痛折磨的美国人提供一种新的治疗选择。”

Ranexa在服用其它抗心绞痛药但仍具有症状的慢性心绞痛患者中进行ERICA(雷诺嗪治疗慢性心绞痛疗效)和CARISA(雷诺嗪合并治疗稳定性心绞痛疗效)两次临床试验。在ERICA试验中,565例每周心绞痛约发作4.5次并服用全量钙通道阻滞剂的患者被随机分为两组,分别服用Ranexa和安慰剂6周。与安慰剂组患者相比, Ranexa组患者每周心绞痛发作次数减少约1次。

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【drug-news】FDA批准安进公

作者:admin@医学,生命科学    2011-01-07 17:14
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