新的ω-3脂肪酸获准用于重度高甘油三酯血症

阿斯利康5月6日宣布，另一个ω-3脂肪酸制剂——ω-3羧酸已获得美国食品药品管理局（FDA）批准，用于成人重度高甘油三酯血症治疗。

阿斯利康声明称，该产品上市规格为1 g胶囊，推荐剂量为每日2 g或4 g，将以商品名Epanova上市销售。

据该产品处方信息，Epanova为“源于鱼油的游离脂肪酸混合物，主要成分为二十碳五烯酸（EPA）和二十二碳六烯酸（EPA）”。批准的适应症是作为饮食疗法的辅助药物，用于降低重度高甘油三酯血症（甘油三酯≥500 mg/dL）成人患者的甘油三酯水平。

声明指出，该批准令是基于 III期临床试验EVOLVE（Epanova降低极高甘油三酯）的研究结果，该研究评价了Epanova对甘油三酯水平极高患者甘油三酯和其他脂类水平的作用。不过，EPANOVA对胰腺炎风险或心血管死亡率和发病率的作用尚未确定。

阿斯利康正在推进Epanova作为重度高甘油三酯血症治疗药物在其他国家的上市批准，并计划开发一种Epanova与他汀类药物固定剂量的复方制剂。

据该公司称，将通过STRENGTH（Epanova对心血管高风险的高甘油三酯血症患者他汀类治疗残余风险的降低作用）试验对该复方制剂的安全性和有效性进行评价。该研究是一项针对心血管疾病风险增加的混合型血脂异常患者心血管结局的大规模研究。

根据clinicaltrials.gov网站信息，该研究是一项随机双盲对照试验，旨在比较玉米油胶囊联合他汀类与Epanova联合他汀类的安全性和有效性，每日1次，给药时间月3~5年，计划入组患者约13,000例。主要终点结局是主要不良心脏事件（心血管死亡、非致命性心梗、非致命性卒中、急诊/选择性冠脉重建术或不稳定性心绞痛住院）复合指标中任一事件首次发作时间。

FDA内分泌和代谢药物咨询委员会的大多数专家在2013年10月召开的会议上建议，在扩大批准另一ω-3脂肪酸（二十碳五烯酸乙酯+他汀类）用于降低冠心病高风险的混合型血脂异常成人患者甘油三酯水平的适应症之前，应等待正在进行的心血管结局试验（REDUCE-IT）结果。专家认为，在批准该适应症之前，应根据该试验结果确认联合用药对血脂的有益作用能否转化为心血管结局的改善。二十碳五烯酸乙酯（商品名为Vascepa）于2012年获准用于重度高甘油三酯血症。

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By: ELIZABETH MECHCATIE, Cardiology News Digital Network

Another omega-3 fatty acid formulation – omega-3-carboxylic acids – has been approved by the Food and Drug Administration for treating adults with severe hypertriglyceridemia, the manufacturer, AstraZeneca, announced May 6.

The product will be available in 1-g capsules, the recommended dosages are 2 g or 4 g per day, and it will be marketed as Epanova, the statement said.

The prescribing information describes Epanova as "a fish oil–derived mixture of free fatty acids primarily composed of EPA [eicosapentaenoic acid] and DHA [docosahexaenoic acid]." The approved indication is as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglycerides of 500 mg/dL or greater).

Approval was based on the results of EVOLVE (for Lowering Very High Triglycerides), a phase III study that evaluated the effects of Epanova on triglycerides and other lipids in patients with very high triglyceride levels, according to the company.

"The effect of EPANOVA on the risk of pancreatitis or on cardiovascular mortality and morbidity has not been determined," the statement said.

AstraZeneca is pursuing approval of Epanova as a treatment for severe hypertriglyceridemia in other countries, and is planning to develop a fixed-dose combination of Epanova with a statin.

The safety and efficacy of Epanova plus statin therapy will be evaluated in the STRENGTH(Statin Residual Risk Reduction With Epanova in High Cardiovascular Risk Patients With Hypertriglyceridemia) trial, a large cardiovascular outcomes study of patients with mixed dyslipidemia who are at an increased risk of cardiovascular disease, according to the company.

The study is a randomized, double-blind, controlled trial that will compare a corn oil capsule plus a statin or Epanova plus a statin, once a day for about 3-5 years in about 13,000 patients, according to the clinicaltrials.gov website. The primary outcome will be the time to the first occurrence of any component of the composite of major adverse cardiac events (cardiovascular death, nonfatal MI, nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina).

At a meeting in October 2013, the majority of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended waiting for the results of an ongoing cardiovascular outcomes trial before expanding the approval of another omega-3 fatty acid, icosapent ethyl plus a statin, for reducing triglycerides in adults with mixed dyslipidemia who are at a high risk of coronary heart disease. Panelists said the results of that study (REDUCE-IT) were needed before this indication was approved to determine if the beneficial effects of the combined treatment on lipids translated into improved cardiovascular outcomes. Icosapent ethyl, marketed as Vascepa, was approved in 2012 as a treatment for severe hypertriglyceridemia.