【通用名称】

洛美他派 ^{[ INN ]}

【英文名称】

Lomitapide ^{[ INN ]}

【拉丁名称】

lomitapidum ^{[ INN ]}

【汉语拼音】

Luo Mei Ta Pai

【其它语种名称】

lomitapide{French}; lomitapide{Spanish}; ломитапид{Russian}; لوميتابيد{Arabic}

【化学资料】

【英文化学名称】

N-(2,2,2-trifluoroethyl)-9-(4-{4-[4'-(trifluoromethyl)[1,1'-biphenyl]-2-carboxamido]piperidin-1-yl}butyl)-9H-fluorene-9-carboxamide ^[INN]

【化学结构式】

[化学结构式图片出处：INN]
　近日，美国食品与药物管理局（FDA）批准了洛美他派（lomitapide）上市，该药获准与低脂饮食和其他降脂药物一起用于治疗纯合性家族性高胆固醇血症（hoFH），降低这些患者的低密低脂蛋白胆固醇（LDL-C）、总胆固醇（TC）、载脂蛋白B（apoB）和非高密度脂蛋白胆固醇。

　　上市后的产品说明书将包含一项加框警告，提醒医务人员和患者该药具有肝脏毒性风险。相关厂商也已向FDA承诺将进行上市后观察队列研究。

　　目前，尚未确定洛美他派对儿科患者或非hoFH的安全性和有效性，也未确定该药对心血管发病率和死亡率的影响。

Aegerion Pharmaceuticals announced that the FDA has approved Juxtapid (lomitapide capsules) as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol, apolipoprotein B and non- high-density-lipoprotein cholesterol in patients with homozygous familial hypercholesterolemia (HoFH). Lomitapide is a MTP-inhibitor that reduces blood levels of cholesterol and triglyceride by limiting the production of lipoproteins from the intestine and liver.

The approval of Juxtapid was based on a multinational, single-arm, open-label, 78-week Phase 3 study, which eva luated the safety and effectiveness of the medicine to reduce LDL-C levels in 29 adult patients with HoFH. When added to the patients' existing lipid-lowering therapy, Juxtapid significantly reduced LDL-C by 40% at Week 26 in the intent-to-treat population with last observation carried forward for the patients who discontinued prematurely. LDL-C was reduced by an average of 50% for the 23 patients who completed the study through Week 26.

Because of the risk of liver toxicity, Juxtapid is available only through a restricted program called the Juxtapid Risk eva luation and Mitigation Strategy (REMS) Program. Aegerion will certify all health care providers who prescribe Juxtapid and the pharmacies that will dispense the medicine.