Odanacatib,选择性组织蛋白酶K抑制剂,显示了类似的药效学和药动学在老年男性和绝经后妇女。
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安德森女士,Gendrano,刘C,杰弗斯年代,马洪C,梅塔,Mostoller K, Zajic年代,莫里斯D,李J,意义下SA
Odanacatib,选择性组织蛋白酶K抑制剂,显示了类似的药效学和药动学在老年男性和绝经后妇女。
中国性金属底座。2014年2月,99 (2):552 - 60。doi: 10.1210 / jc.2013 - 1688。Epub 2013年11月25日。
- PubMed ID
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24276460 (在PubMed]
- 文摘
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背景:Odanacatib是组织蛋白酶K抑制剂在治疗骨质疏松症的发展。评价治疗以确保治疗效果相关不管性是临床上重要的。方法:在这个双盲、随机对照试验,老男人(50 - 75岁)和绝经后妇女(年龄在45 - 75岁)被给予odanacatib 50 mg曾经为4周每周或安慰剂。药效学(PD)评价测量加权平均抑制(WAI)尿伴交联端肽的I型胶原蛋白/肌酐(uNTx / Cr)后odanacatib管理。药代动力学(PK)参数数据收集和分析性的因素进行PK / PD关系。不良事件监测。围的假设是uNTx / Cr > 40%(包括> 90%置信区间的下限为40% (CIs))对老年男性和绝经后女性,不会有重要差异曲线下的面积从0到168小时(auc0 - 168 h)男人和女人之间,,odanacatib会安全和耐受性良好。结果:共有44个科目(32男12女)是随机的。最小二乘均值围在周4 (uNTx / Cr)为42.8%(90%可信区间,35.5% - -49.3%),男性和42.7%(90%可信区间,30.3% -52.9%)为女性;意思是值> 40%,但下界指定< 40%的主要假设。 The differences among men and women in PD parameters were not meaningful (0.1; 90% CI, -14.7 to 14.9). PK parameters for both groups were comparable (geometric mean ratio of AUC0-168 h, 0.90; 90% CI, 0.75-1.07). A PK/PD analysis found that the EC50 and maximum fractional inhibition were similar in male and female subjects. There were no notable or serious adverse events in this study. CONCLUSIONS: Although the primary hypothesis was not met, there were no clinically meaningful differences in PD, PK, or PK/PD parameters between older men and postmenopausal women, supporting further research on odanacatib (50 mg once weekly) as a treatment for male osteoporosis. Odanacatib was generally well tolerated.
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