药代动力学相互作用pitavastatin、缬沙坦:一项随机、非盲交叉研究在健康男性志愿者。

文章的细节

引用
复制到剪贴板

荣格JA,能剧YH,金,金MJ,金正日YH,荣格是的,Lim HS, Bae KS

药代动力学相互作用pitavastatin、缬沙坦:一项随机、非盲交叉研究在健康男性志愿者。

其他。2012年4月,34 (4):958 - 65。doi: 10.1016 / j.clinthera.2012.01.026。Epub 2012 3月10。

PubMed ID
22410289 (在PubMed
]
文摘

背景:Pitavastatin 3-hydroxy-3-methylglutaryl辅酶a还原酶的竞争性抑制剂,缬沙坦,使用血管紧张素受体阻断剂,同时在一些患者hyperlipidemic和高血压。然而,迄今为止,没有发表的研究探索pitavastatin、缬沙坦之间是否有交互作用。摘要目的:本研究的目的是探讨潜在的药代动力学相互作用在韩国pitavastatin、缬沙坦在健康男性志愿者。方法:随机、非盲交叉研究是在健康男性进行的朝鲜志愿者。在不同序列,每个主题收到pitavastatin 2 x 2毫克,缬沙坦2 x 160毫克,而治疗,每天一次连续7天,7天,洗脱期之间的治疗时期。在稳态等离子体样本获得pitavastatin、缬沙坦的药代动力学评价。药效学评价包括血脂水平和生命体征测量(收缩压和舒张压(分别SBP和菲律宾)和脉冲重复频率(公关))。安全性评估,包括生命体征测量、ECG和临床实验室检测,在每个主题进行。结果:共招收了24名受试者(平均年龄30.5岁(范围23.0 - -45.0年);平均体重,71.2公斤(范围56.1 - -86.0公斤); and mean body mass index, 23.2 kg/m(2) [range, 19.2-25.8 kg/m(2)]). The 95% CIs of the geometric mean ratios of AUC(tau) and C(max,ss) of pitavastatin were 0.97 to 1.11 and 0.73 to 1.09, respectively. The 95% CIs of the geometric mean ratios of AUC(tau) and C(max,ss) of valsartan were 0.90 to 1.27 and 0.81 to 1.29. Pitavastatin administered as monotherapy and in combination with valsartan was associated with significantly lowered total cholesterol and LDL-C compared with valsartan monotherapy (both, P < 0.05). Differences in lipid-lowering effects were not statistically significant between pitavastatin monotherapy and pitavastatin combined with valsartan. Valsartan monotherapy and valsartan combined with pitavastatin were associated with significantly lower SBP and DBP compared with baseline (both, P < 0.05), although no significant changes in PR were observed. No significant differences in BP or PR changes were noted between concurrent administration of valsartan monotherapy compared with pitavastatin + valsartan. There were no serious AEs reported, and none of the subjects discontinued the study due to AEs. CONCLUSIONS: The pharmacokinetic profiles of pitavastatin and valsartan administered as monotherapy were comparable to combination treatment in these healthy male Korean volunteers, suggesting that individual pharmacokinetic properties are not significantly affected by concurrent administration. The concurrent administration of pitavastatin and valsartan was generally well tolerated. The findings from the present study provide a basis for a larger study in hypertensive patients with hyperlipidemia.

DrugBank数据引用了这篇文章

药物