Clarification of P-glycoprotein inhibition-related drug-drug interaction risks based on a literature search of the clinical information

被引:12
作者
Umeyama, Yukari [1 ]
Fujioka, Yasushi [1 ]
Okuda, Teruaki [1 ]
机构
[1] Takeda Pharmaceut Co Ltd, Div Pharmaceut Res, Drug Metab & Pharmacokinet Res Labs, Fujisawa, Kanagawa 2518555, Japan
关键词
CYP3A; drug-drug interaction; P-glycoprotein; RENAL-TRANSPLANT RECIPIENTS; CYTOCHROME P4503A CYP3A; HIV PROTEASE INHIBITORS; BLOOD-BRAIN-BARRIER; HEALTHY-VOLUNTEERS; PLASMA-CONCENTRATIONS; ORAL BIOAVAILABILITY; PHARMACOKINETIC INTERACTIONS; GRAPEFRUIT JUICE; CYCLOSPORINE-A;
D O I
10.3109/00498254.2014.928958
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
1. Recently, the Food and Drug Administration (FDA) and European Medicines Agency have shown decision trees to determine whether a drug candidate is an inhibitor of P-glycoprotein (P-gp). However, there has been no clear information on whether P-gp inhibition can be significant in clinical drug-drug interactions (DDIs). The purpose of this study was to confirm the effect of P-gp inhibition through comprehensive analysis of the clinical DDI studies. 2. Clinical information on P-gp inhibition was collected using the University of Washington Metabolism and Transport Drug Interaction Database (TM). The risks of P-gp inhibition-related DDI were qualitatively evaluated in terms of the contribution of CYP3A inhibition. The degrees of DDI risk were categorized using the area under the plasma concentration-time curve increase ratio (AUCR), according to the FDA DDI criteria. 3. When both P-gp and CYP3A were inhibited, the DDI risks were potent in 25% of the studies. When CYP3A inhibition did not contribute to the DDI, no study was categorized as potent DDI risk, and the detailed analysis revealed that AUCRs were basically <3.0. The DDI risk caused by P-gp inhibition solely would be limited, although the use of P-gp substrates with narrow therapeutic range should be carefully controlled.
引用
收藏
页码:1135 / 1144
页数:10
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