In vitro evaluation of potential drug interactions mediated by cytochrome P450 and transporters for luseogliflozin, an SGLT2 inhibitor

References

• Abdul-Ghani MA, Norton L, DeFronzo RA. (2011). Role of sodium-glucose cotransporter 2 (SGLT 2) inhibitors in the treatment of type 2 diabetes. Endocr Rev 32:515–31
   PubMed Web of Science ®Google Scholar
• Astellas Pharma I. (2016). Suglat (ipragliflozin) package insert. Available from: https://amn.astellas.jp/jp/di/list/sgl/pi_sgl.pdf [Japanese] [last accessed 16 May 2016]
   Google Scholar
• AstraZeneca KK. (2016). Forxiga (dapagliflozin) package insert. Available from: http://www2.astrazeneca.co.jp/product/di.asp?pr_kikaku_id=FXG05&di_type=01 [Japanese] [last accessed 16 May 2016]
   Google Scholar
• Bailey CJ. (2011). Renal glucose reabsorption inhibitors to treat diabetes. Trends Pharmacol Sci 32:63–71
   PubMed Web of Science ®Google Scholar
• Boehringer Ingelheim GmbH. (2016). Jardiance (empagliflozin) package insert. Available from: http://www.bij-kusuri.jp/leaflet/attach/pdf/jad_t10_pi.pdf [Japanese] [last accessed 16 May 2016]
   Google Scholar
• Devineni D, Polidori D. (2015). Clinical pharmacokinetic, pharmacodynamic, and drug-drug interaction profile of Canagliflozin, a sodium-glucose co-transporter 2 inhibitor. Clin Pharmacokinet 54:1027–41
   PubMed Web of Science ®Google Scholar
• Galteau MM, Shamsa F. (2003). Urinary 6β-hydroxycortisol: a validated test for evaluating drug induction or drug inhibition mediated through CYP3A in humans and in animals. Eur J Clin Pharmacol 59:713–33
   PubMed Web of Science ®Google Scholar
• Giacomini KM, Huang SM, Tweedie DJ, et al (2010). Membrane transporters in drug development. Nat Rev Drug Discov 9:215–36
   PubMed Web of Science ®Google Scholar
• Hasegawa M, Chino Y, Horiuchi N, et al (2015). Preclinical metabolism and disposition of luseogliflozin, a novel antihyperglycemic agent. Xenobiotica 45:1105–15
   Google Scholar
• Huang SM, Temple R, Throckmorton DC, et al (2007). Drug interaction studies: study design, data analysis, and implications for dosing and labeling. Clin Pharmacol Ther 81:298–304
   PubMed Web of Science ®Google Scholar
• Kakinuma H, Oi T, Hashimoto-Tsuchiya Y, et al (2010). (1S)-1,5-anhydro-1-[5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl]-1-thio-D-glucito l (TS-071) is a potent, selective sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for type 2 diabetes treatment. J Med Chem 53:3247–61
   PubMed Web of Science ®Google Scholar
• Kirchheiner J, Roots I, Goldammer M, et al (2005). Effect of genetic polymorphisms in cytochrome p450 (CYP) 2C9 and CYP2C8 on the pharmacokinetics of oral antidiabetic drugs: clinical relevance. Clin Pharmacokinet 44:1209–25
   PubMed Web of Science ®Google Scholar
• Macha S, Sennewald R, Rose P, et al (2013). Lack of clinically relevant drug-drug interaction between empagliflozin, a sodium glucose cotransporter 2 inhibitor, and verapamil, ramipril, or digoxin in healthy volunteers. Clin Ther 35:226–35
   PubMed Web of Science ®Google Scholar
• Macha S, Koenen R, Sennewald R, et al (2014). Effect of gemfibrozil, rifampicin, or probenecid on the pharmacokinetics of the SGLT2 inhibitor empagliflozin in healthy volunteers. Clin Ther 36:280–90
   PubMed Web of Science ®Google Scholar
• Miyata A, Hasegawa M, Hachiuma K, et al (2016). Metabolite profiling and enzyme reaction phenotyping of luseogliflozin, a sodium glucose cotransporter 2 inhibitor, in humans. Xenobiotica. [in press]
   Google Scholar
• Mizuno-Yasuhira A, Nakai Y, Gunji E, et al (2011). A strategy for assessing potential drug-drug interactions of a concomitant agent against a drug absorbed via an intestinal transporter in humans. Drug Metab Dispos 42:1456–65
   Web of Science ®Google Scholar
• Obermeier M, Yao M, Khanna A, et al (2010). In vitro characterization and pharmacokinetics of dapagliflozin (BMS-512148), a potent sodium-glucose cotransporter type II inhibitor, in animals and humans. Drug Metab Dispos 38:405–14
   PubMed Web of Science ®Google Scholar
• Peng CC, Templeton I, Thummel KE, et al (2011). Evaluation of 6β-hydroxycortisol, 6β-hydroxycortisone, and a combination of the two as endogenous probes for inhibition of CYP3A4 in vivo. Clin Pharmacol Ther 89:888–95
   PubMed Web of Science ®Google Scholar
• Raggers RJ, Vogels I, van Meer G. (2002). Upregulation of the expression of endogenous Mdr1 P-glycoprotein enhances lipid translocation in MDCK cells transfected with human MRP2. Histochem Cell Biol 117:181–5
   PubMed Web of Science ®Google Scholar
• Sanofi KK. (2016). Apleway (tofogliflozin) package insert. Available from: http://e-mr.sanofi.co.jp/di/tenpu/apleway.pdf?date=1463384017031 [Japanese] [last accessed May 2016]
   Google Scholar
• Sasaki T, Seino Y, Fukatsu A, et al (2014). Safety, pharmacokinetics, and pharmacodynamics of single and multiple luseogliflozin dosing in healthy Japanese males: a randomized, single-blind, placebo-controlled trial. Adv Ther 31:345–61
   PubMed Web of Science ®Google Scholar
• Sasaki T, Seino Y, Fukatsu A, et al (2015). Absence of drug-drug interactions between luseogliflozin, a sodium-glucose co-transporter-2 inhibitor, and various oral antidiabetic drugs in healthy Japanese males. Adv Ther 32:404–17
   PubMed Web of Science ®Google Scholar
• Scheen AJ. (2014). Drug-drug interactions with sodium-glucose cotransporters type 2 (SGLT2) inhibitors, new oral glucose-lowering agents for the management of type 2 diabetes mellitus. Clin Pharmacokinet 53:295–304
   PubMed Web of Science ®Google Scholar
• Seino Y. (2014). Luseogliflozin for the treatment of type 2 diabetes. Expert Opin Pharmacother 15:2741–9
   PubMed Web of Science ®Google Scholar
• Taisho Toyama Pharmaceutical Co., Ltd. (2016). Lusefi (Luseogliflozin) package insert. Available from: http://medical.taishotoyama.co.jp/data/tenp/pdf/tenp_lsf.pdf [Japanese] [last accessed 16 May 2016]
   Google Scholar
• US FDA, Center for Drug Evaluation and Research (CDER). (2012). Guidance for industry. Drug interaction studies - study design, data analysis, implications for dosing, and labeling recommendations. draft guidance
   Google Scholar
• van Herwaarden AE, Schinkel AH. (2006). The function of breast cancer resistance protein in epithelial barriers, stem cells and milk secretion of drugs and xenotoxins. Trends Pharmacol Sci 27:10–16
   PubMed Web of Science ®Google Scholar
• Vlaming ML, Lagas JS, Schinkel AH. (2009). Physiological and pharmacological roles of ABCG2 (BCRP): recent findings in Abcg2 knockout mice. Adv Drug Deliv Rev 61:14–25
   PubMed Web of Science ®Google Scholar
• Wienkers LC, Heath TG. (2005). Predicting in vivo drug interactions from in vitro drug discovery data. Nat Rev Drug Discov 4:825–33
   PubMed Web of Science ®Google Scholar
• Yamamoto K, Uchida S, Kitano K, et al (2011). TS-071 is a novel, potent and selective renal sodium-glucose cotransporter 2 (SGLT2) inhibitor with anti-hyperglycaemic activity. Br J Pharmacol 164:181–91
   PubMed Web of Science ®Google Scholar
• Zell M, Husser C, Kuhlmann O, et al (2014). Metabolism and mass balance of SGLT2 inhibitor tofogliflozin following oral administration to humans. Xenobiotica 44:369–78
   PubMed Web of Science ®Google Scholar