Mechanism of ActionEzetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine. In a 2-week clinical study in 18 hypercholesterolemic patients, ZETIA inhibited intestinal cholesterol absorption by 54%, compared with placebo. ZETIA had no clinically meaningful effect on the plasma concentrations of the fat-soluble vitamins A, D, and E (in a study of 113 patients), and did not impair adrenocortical steroid hormone production (in a study of 118 patients).
The cholesterol content of the liver is derived predominantly from three sources. The liver can synthesize cholesterol, take up cholesterol from the blood from circulating lipoproteins, or take up cholesterol absorbed by the small intestine. Intestinal cholesterol is derived primarily from cholesterol secreted in the bile and from dietary cholesterol.
Ezetimibe has a mechanism of action that differs from those of other classes of cholesterol-reducing compounds (statins, bile acid sequestrants [resins], fibric acid derivatives, and plant stanols). The molecular target of ezetimibe has been shown to be the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which is involved in the intestinal uptake of cholesterol and phytosterols.
Ezetimibe does not inhibit cholesterol synthesis in the liver, or increase bile acid excretion. Instead, ezetimibe localizes at the brush border of the small intestine and inhibits the absorption of cholesterol, leading to a decrease in the delivery of intestinal cholesterol to the liver. This causes a reduction of hepatic cholesterol stores and an increase in clearance of cholesterol from the blood; this distinct mechanism is complementary to that of statins and of fenofibrate [see Clinical Studies (14.1)].
ZETIA is an inhibitor of intestinal cholesterol (and related phytosterol) absorption indicated as an adjunct to diet to:
• Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary hyperlipidemia, alone or in combination with an HMGCoA reductase inhibitor (statin) (1.1)
• Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia in combination with fenofibrate (1.1)
• Reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), in combination with atorvastatin or simvastatin (1.2)
• Reduce elevated sitosterol and campesterol in patients with homozygous sitosterolemia (phytosterolemia) (1.3)
Limitations of Use (1.4)
• The effect of ZETIA on cardiovascular morbidity and mortality has not been determined.
• ZETIA has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
Dr. Reddy's总部位于印度海得拉巴，是全球领先的活性药物成分（API）供应商之一。 Dr. Reddy's的API业务是美国、欧洲、巴西、拉丁美洲、日本、中国、韩国和新兴市场的制药公司的首选合作伙伴。
Dr. Reddy's博士的API业务在过去30多年来在开发和制造复杂API（如类固醇，多肽，复杂长链分子和高效API（HPAPI /肿瘤药物））方面所建立的深厚技术优势中茁壮成长。 我们在知识产权和法规事务方面的实力可以帮助我们始终如一地达到并超越监管标准，从而为这一专业知识提供补充。 Dr. Reddy's博士 Ezetimibe API是研发，知识产权和监管方面广泛专业知识的结果。
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