阿斯利康（AstraZeneca）5月6日宣布，高血脂新药Epanova（ω-3-羧酸）获FDA批准，辅助饮食，用于降低严重高甘油三脂血症（甘油三酯水平≥500mg/升）成人患者的甘油三酯水平。该药的获批，对于阿斯利康来说是一个重要的里程碑，将加强该公司现有的心血管药物产品组合。阿斯利康表示，将进一步评估Epanova的临床属性，并鉴别可能从该药中受益的其他患者群体。
Epanova是FDA批准的首个处方ω-3游离脂肪酸，有2个剂量选择：每日2克（2粒胶囊）或4克（4粒胶囊）。Epanova的获批，对于数目庞大且正在不断增长的严重高甘油三酯患者群体来说，是个好消息。该药的疗效已在临床试验中证实，可为临床医生和患者提供一种新的重要治疗选择。Epanova是一种含涂层明胶软胶囊，包含一组源于鱼油的多不饱和脂肪酸混合物（长链ω-3和ω-6脂肪酸），能够有效降低甘油三酯，并改善其他主要血脂参数。
Epanova是一种纯的、游离脂肪酸，可为医生提供一个选择，来有效管理高甘油三脂血症，同时不会显著提高患者的药物负担。Epanova的获批，是基于一个临床开发项目的数据，包括来自III期EVOLVE试验的积极数据，该试验调查了Epanova降低高甘油三脂血症患者甘油三酯水平和其他关键参数的疗效。目前，Epanova对胰腺炎或心血管发病率和死亡风险的影响尚未确定。
Epanova由阿斯利康于2013年7月耗资4.43亿美元收购Omthera制药后获得，此次收购将增强阿斯利康后期心血管疾病药物管线。目前Epanova主要开发用于严重高甘油三脂血症患者（甘油三酯水平≥500mg/dL）的治疗。该领域中，阿斯利康将与葛兰素史克（GSK）和Amartin竞争，这2个公司均有类似的鱼油药品获批。
甘油三酯（triglycerides）是存在于血液中的一种脂质（脂肪），是机体的重要能量来源。但一些人的甘油三酯水平非常高（严重高甘油三脂血症），这意味着这类患者的血液中存在过多的脂肪，这会导致严重的并发症。在美国，有近400万严重高甘油三脂血症患者，随着相关疾病（如肥胖症和糖尿病）患病率的持续上升，严重高甘油三脂血症患者群体的数目也在不断增长。
目前，阿斯利康正在继续评估Epanova的临床属性。阿斯利康计划通过一项大规模心血管预后试验STRENGTH，在心血管疾病风险增加的混合型血脂异常患者群体中，评估Epanova联合他汀类药物对心血管预后的安全性和疗效。阿斯利康也计划开发一种固定剂量的Epanova/他汀类药物组合疗法。正在开发一种Crestor+Epanova固定剂量组合，
对于阿斯利康而言，心血管医学是一个关键领域，该公司最畅销药物为降胆固醇药物Crestor，该药属于他汀类药物。目前，阿斯利康计划通过一项大规模心血管预后试验STRENGTH，在心血管疾病风险增加的混合型血脂异常患者群体中，评估该Epanova+Crestor组合疗法对心血管预后的安全性和疗效。阿斯利康也计划开发一种Epanova/Crestor固定剂量组合药物，如果获得成功，将有望使Crestor的专营权延长至2016年以后
IMPORTANT SAFETY INFORMATION FOR EPANOVA® (omega-3-carboxylic acids) Capsules
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EPANOVA is contraindicated in patients with known hypersensitivity to EPANOVA or any of its components
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In some patients, EPANOVA increases LDL-C levels. LDL-C levels should be monitored periodically during therapy with EPANOVA
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In patients with hepatic impairment, ALT and AST levels should be monitored periodically during therapy with EPANOVA
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EPANOVA should be used with caution in patients with known hypersensitivity to fish and/or shellfish
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Some published studies with omega-3-fatty acids demonstrated prolongation of bleeding time, which did not exceed normal limits and did not produce clinically significant bleeding episodes. Patients taking anti-platelet agents or anticoagulants were excluded from EPANOVA clinical trials involving patients with hypertriglyceridemia. Nonetheless, patients receiving treatment with EPANOVA and an anticoagulant or other drugs affecting coagulation (eg, anti-platelet agents) should be monitored periodically
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Most common adverse reactions with EPANOVA 2 grams and 4 grams, respectively, were diarrhea (7%, 15%), nausea (4%, 6%), abdominal pain or discomfort (3%, 5%) and eructation (3%, 3%)
INDICATION
EPANOVA 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 before receiving EPANOVA and should continue this diet during treatment with EPANOVA.
Laboratory studies should be done to ascertain that the triglyceride levels are consistently abnormal before instituting EPANOVA therapy. Attempts should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.
Limitations of Use:
The effect of EPANOVA on the risk for pancreatitis has not been determined.
The effect of EPANOVA on cardiovascular mortality and morbidity in patients has not been determined.
Please see full Prescribing Information.
处方说明
http://www1.astrazeneca-us.com/pi/epanova.pdf#page=1
临床信息
http://clinicaltrials.gov/ct2/show/study/NCT01208961
