Niaspan(R)在慢性肾病和透析患者中的药代动力学和剂量推荐。
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刘建军，刘建军，刘建军，刘建军，刘建军
Niaspan(R)在慢性肾病和透析患者中的药代动力学和剂量推荐。
肾移植杂志，2011,26(1):276-82。doi: 10.1093 /无损检测/ gfq344。Epub 2010年6月17日。
- PubMed ID
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20562093 (PubMed视图]
- 摘要
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背景:Niaspan(R)是一种烟酸缓释制剂，与速释和缓释制剂相比，耐受性提高。它用于治疗高密度脂蛋白水平低的高甘油三酯血症。这种类型的血脂异常经常出现在慢性肾脏疾病(CKD)患者中。由于缺乏药代动力学数据，目前尚无针对这些患者的剂量建议。本研究旨在分析慢性肾病患者和透析患者缓释烟酸的药代动力学，以得出推荐剂量。方法:10名透析患者和8名CKD患者入组一项前瞻性、三期、开放标签的药代动力学研究。他们在第一周每天服用500毫克Niaspan(R)，在第二周每天服用1000毫克，在第三周每天服用1500毫克。每个治疗单元的第4天，在给药后24 h采集11份血浆样本，分析烟酸(NA)及其代谢物烟酰胺和烟尿酸(NUA)。结果:CKD患者的中位血浆NA浓度明显高于透析患者，但不高于无肾损害患者。透析患者NA的t(max)平均为0.75 h, CKD患者为3.0 h，因此，特别是透析患者，明显短于缓释制剂的预期。 It is particularly noticeable that the AUC, C(max) and t(1/2) of the metabolite NUA are significantly higher in dialysis patients in comparison to CKD patients. This may indicate that the dialysis was not effective in removing this metabolite. However, there was no correlation between the incidence of flush and the concentration of NUA. Another possibility could be a drug-drug interaction with omeprazole via CYP450 enzymes. CONCLUSIONS: These data suggest that no dose adjustment of Niaspan(R) is necessary in patients with renal impairment. Despite an extended-release formulation of NA, we could not detect a delay in t(max) especially in dialysis patients. We found no correlation between the incidence of flush and the NUA concentration. Furthermore, there were hints of an interaction with omeprazole.
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