gemcabene基于模型的发展,一个新的lipid-altering代理。

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王Mandema JW,赫尔曼·D, W, Sheiner T, Milad M, Bakker-Arkema R,哈特曼D

gemcabene基于模型的发展,一个新的lipid-altering代理。

aap j . 2005 10月7;7 (3):E513-22。

PubMed ID

16353929 (在PubMed

]

文摘

本研究的目的是评估的价值基于模型,定量决策在gemcabene的发展,一种新型lipid-altering代理。的决定是由一个模型可能的临床资料gemcabene与竞争对手相比,如3-hydroxymethylglutaryl辅酶a还原酶抑制剂(他汀类药物),胆固醇吸收抑制剂ezetimibe及其组合。剂量反应模型为脂质开发效果(低密度脂蛋白胆固醇(低密度脂蛋白)和高密度脂蛋白胆固醇);不利影响,如持续的丙氨酸转氨酶升高和肌痛;耐受性的问题,如头痛;和风险降低冠状动脉疾病事件5他汀类药物,ezetimibe gemcabene,他们的组合。集成模型是基于公开的联合分析汇总数据和专有数据和包括信息从近10000例患者的立场。模型是可用的和可访问模型浏览器开发团队使用Pharsight药物模型可视化技术。建模极大地促进了临床资料的理解gemcabene时单独或与他汀类药物相结合。他汀类药物之间的相互作用和gemcabene密度降低的效果被发现从他汀类药物之间的相互作用和ezetimibe明显不同。 Ezetimibe was found to have a pharmacological-independent interaction resulting in additional LDL-C lowering over the entire statin dose range. The gemcabene interaction was found to be less than independent, resulting in almost no additional LDL-C lowering at high-statin doses, although the drug has a significant LDL-C effect when administered alone or in combination with a low dose of a statin. The quick availability of the model after completion of the first phase II trial in the target patient population and the ability of the team to explore the potential clinical efficacy and safety of gemcabene in comparison with alternative treatment options facilitated a quick decision to stop development.

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药物

Gemcabene