最近，美国食品药品管理局(FDA)已经批准Vascepa(icosapent ethyl)胶囊作为成人重度高甘油三酯血症(TG水平≥500mg/dl)患者饮食疗法的辅助治疗药物，用于降低甘油三酯(TG)水平。Vascepa是一种超纯的Ω-3脂肪酸产品。该公司通过一项随机、安慰剂对照、双盲、设平行组的研究对Vascepa的有效性和安全性进行了评估，受试者为空腹TG水平非常高(500~2000mg/dl)的成人患者。基线时，25%的患者接受Vascepa与他汀配伍治疗，28%患有糖尿病，39%的患者TG水平>750mg/dl。 4g剂量的Vascepa治疗组患者在接受12周治疗后甘油三酯中位水平降低了33%，与安慰剂对照组相比具有统计学意义(P<0.001)，其低密度脂蛋白胆固醇水平相对于安慰剂对照组未升高。Vascepa治疗组患者中最常报告的不良反应为关节痛。
Vascepa对重度高甘油三脂血症患者胰腺炎风险的影响及其对重度高甘油三脂血症患者心血管死亡率和发病率的影响均尚未确定。
Vascepa的日剂量为4g，通过口服用药。患者在接受Vascepa治疗前及治疗期间，应适当控制营养摄入量和体力活动。
Amarin预计Vascepa在2013年第一季度初上市
美国FDA已经批准了Vascepa(icosapent ethyl, 二十碳五烯酸胶囊)的上市，Vascepa就是深海鱼油里面的一种EPA。 但是Vascepa适用在有严重(≥ 500mg/dL)高甘油三酯血症成年患者中作为膳食辅助减低甘油三酸酯(TG)水平，推荐每天剂量是4 g。
VASCEPA™(icosapent ethyl)胶囊，为口服使用
美国初次批准：2012
适应证和用途
VASCEPA是一种二十碳五烯酸的乙酯(EPA)适用在有严重(≥ 500 mg/dL)高甘油三酯血症成年患者中作为膳食辅助减低甘油三酸酯(TG)水平。
使用的限制：
（1）尚未确定有严重高甘油三酯血症患者中VASCEPA对胰腺炎的风险的影响。
（2）尚未确定有严重高甘油三酯血症患者中VASCEPA对心血管死亡率和发病率的影响。
剂量和给药方法
VASCEPA的每天剂量是4 g每天服粒2胶囊每天2次与食物。
应劝告患者整吞VASCEPA胶囊。不要破开，粉碎，溶解，或咀嚼VASCEPA。
剂型和规格
胶囊：1 g。(3)

INDICATIONS AND USAGE
VASCEPA™ (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet and exercise regimen before receiving VASCEPA and should continue this diet and exercise regimen with VASCEPA.
Attempts should be made to control any medical problems such as diabetes mellitus, hypothyroidism, and alcohol intake that may contribute to lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed, if possible, prior to consideration of TG-lowering drug therapy.
Limitations of Use:
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
The effect of VASCEPA on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
DOSAGE AND ADMINISTRATION
Assess lipid levels before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage as appropriate. [see Indications and Usage (1) ].
Patients should engage in appropriate nutritional intake and physical activity before receiving VASCEPA, which should continue during treatment with VASCEPA.
The daily dose of VASCEPA is 4 grams per day taken as 2 capsules twice daily with food.
Patients should be advised to swallow VASCEPA capsules whole. Do not break open, crush, dissolve, or chew VASCEPA.
DOSAGE FORMS AND STRENGTHS
VASCEPA capsules are supplied as 1-gram amber-colored soft-gelatin capsules imprinted with VASCEPA.
HOW SUPPLIED/STORAGE AND HANDLING
VASCEPA (icosapent ethyl) capsules are supplied as 1-gram amber-colored soft-gelatin capsules imprinted with VASCEPA.
Bottles of 120: NDC 52937-001-20.
Store at 20° to 25° C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.
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产地国家: 美国
原产地英文商品名:
VASCEPA 1g 120caps
原产地英文药品名:
ICOSAPENT ETHYL
中文参考商品译名:
VASCEPA胶囊 1克/胶囊 120胶囊/瓶
中文参考药品译名:
二十碳五烯酸
生产厂家英文名: