Luseogliflozin, an SGLT2 Inhibitor, in Japanese Patients With Mild/Moderate Hepatic Impairment: A Pharmacokinetic Study

Clinical Pharmacology in Drug Development

Volumn 6, Issue 5, 2017, Pages 439-447

  Samukawa, Yoshishige ^a   Sata, Michio ^b   Furihata, Kenichi ^c   Ito, Toshifumi ^d   Ueda, Naohiko ^e   Ochiai, Hidekazu ^a   Sakai, Soichi ^a   Kumagai, Yuji ^f  

^a TAISHO PHARMACEUTICAL CO LTD   (Japan)

^b KURUME UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^c P one Clinic Keikokai Medical Corporation   (Japan)

^d OSAKA KOSEI NENKIN HOSPITAL   (Japan)

^e Medical Corporation Kyosoukai AMC Nishi Umeda Clinic   (Japan)

^f KITASATO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

Author keywords

diabetes; hepatic impairment; luseogliflozin; pharmacokinetics; SGLT2 inhibitor

Indexed keywords

DRUG METABOLITE; LUSEOGLIFLOZIN; 1,5-ANHYDRO-1-(5-(4-ETHOXYBENZYL)-2-METHOXY-4-METHYLPHENYL)-1-THIOGLUCITOL; ANTIDIABETIC AGENT; GLUCOSE; SLC5A2 PROTEIN, HUMAN; SODIUM GLUCOSE COTRANSPORTER 2; SORBITOL;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CLINICAL ARTICLE; CLINICAL EVALUATION; CONTROLLED STUDY; DISEASE SEVERITY; DRUG HALF LIFE; DRUG SAFETY; FEMALE; HUMAN; JAPANESE (PEOPLE); LIVER DISEASE; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL; RHINOPHARYNGITIS; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; URINALYSIS; URINARY EXCRETION; ANALOGS AND DERIVATIVES; ANTAGONISTS AND INHIBITORS; BLOOD; CLINICAL TRIAL; METABOLISM; MIDDLE AGED; URINE;

ADULT; AGED; AREA UNDER CURVE; FEMALE; GLUCOSE; HUMANS; HYPOGLYCEMIC AGENTS; LIVER DISEASES; MALE; MIDDLE AGED; SODIUM-GLUCOSE TRANSPORTER 2; SORBITOL;

EID: 85028772096     PISSN: 2160763X     EISSN: 21607648     Source Type: Journal    
DOI: 10.1002/cpdd.364     Document Type: Article

References (24)

1. Holstein A, Hinze S, Thiessen E, Plaschke A, Egberts EH. Clinical implications of hepatogenous diabetes in liver cirrhosis. J Gastroenterol Hepatol. 2002;17(6):677–681.
2. Kawaguchi T, Taniguchi E, Itou M, Sakata M, Sumie S, Sata M. Insulin resistance and chronic liver disease. World J Hepatol. 2011;3(5):99–107.
3. Kawaguchi T, Taniguchi E, Morita Y, et al. Association of exogenous insulin or sulphonylurea treatment with an increased incidence of hepatoma in patients with hepatitis C virus infection. Liver Int. 2010;30(3):479–486.
4. Garcia-Compean D, Jaquez-Quintana JO, Gonzalez-Gonzalez JA, et al. Liver cirrhosis and diabetes: risk factors, pathophysiology, clinical implications and management. World J Gastroenterol. 2009;15:280–288
5. Kakinuma H, Oi T, Hashimoto-Tsuchiya Y, et al. (1S)-1,5-anhydro-1-[5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl]-1-thio-D-glucitol (TS-071) is a potent, selective sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for type 2 diabetes treatment. J Med Chem. 2010;53(8):3247–3261.
6. Yamamoto K, Uchida S, Kitano K, et al. TS-071 is a novel, potent and selective renal sodium-glucose cotransporter 2 (SGLT2) inhibitor with anti-hyperglycaemic activity. Br J Pharmacol. 2011;164(1):181–191.
7. Seino Y, Sasaki T, Fukatsu A, Sakai S, Samukawa Y. Efficacy and safety of luseogliflozin monotherapy in Japanese patients with type 2 diabetes mellitus: a 12-week, randomized, placebo-controlled, phase II study. Curr Med Res Opin. 2014;30:1245–1255.
8. Seino Y, Sasaki T, Fukatsu A, et al. Dose-finding study of luseogliflozin in Japanese patients with type 2 diabetes mellitus: a 12-week, randomized, double-blind, placebo-controlled, phase II study. Curr Med Res Opin. 2014;30:1231–1244.
9. Miyata A, Hasegawa M, Hachiuma K, et al. Metabolite profiling and enzyme reaction phenotyping of luseogliflozin, a sodium–glucose cotransporter 2 inhibitor, in humans. Xenobiotica. 2017;47(4):332–345.
10. Chino Y, Hasegawa M, Fukasawa Y, et al. In vitro evaluation of potential drug interactions mediated by cytochrome P450 and transporters for luseogliflozin, an SGLT2 inhibitor, Xenobiotica. 2017;47(4):314–323.
11. Sasaki T, Seino Y, Fukatsu A, Sakai S, Samukawa Y. Safety, pharmacokinetics, and pharmacodynamics of single and multiple luseogliflozin dosing in healthy Japanese males: a randomized, single-blind, placebo-controlled trial. Adv Ther. 2014;31(3):345–361.
12. Sasaki T, Seino Y, Fukatsu A, Ubukata M, Sakai S, Samukawa Y. 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. 2015;32:404–417.
13. Sasaki T, Seino Y, Samukawa Y, Sakai S, Watanabe T. Effect of gender and age on the pharmacokinetics of luseogliflozin (TS-071), a selective SGLT2 inhibitor [ADA 2012, Philadelphia]. Poster (1069-P).
14. Haneda M, Seino Y, Sasaki T, et al. Luseogliflozin (TS-071), a selective SGLT2 inhibitor, improves glycemic control in Japanese type 2 diabetic subjects with renal impairment [EASD 2012, Berlin]. Abstract 741.
15. Child CG, Turcotte JG. Surgery and portal hypertension. Major Probl Clin Surg. 1964;1:1–85.
16. Pugh RN, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the oesophagus for bleeding oesophageal varices. Br J Surg. 1973;60(8):646–649.
17. Le Couteur DG, Fraser R, Hilmer SN, et al. The hepatic sinusoid in aging and cirrhosis: effects on hepatic substrate disposition and drug clearance. Clin Pharmacokinet. 2005:44:187–200.14.
18. Zhang W, Krauwinkel WJJ, Keirns J, et al. The effect of moderate hepatic impairment on the pharmacokinetics of ipragliflozin, a novel sodium glucose co-transporter 2 (SGLT2) inhibitor. Clin Drug Investig. 2013;33(7):489–496.
19. Kasichayanula S, Liu X, Zhang W, Pfister M, LaCreta FP, Boulton DW. Influence of hepatic impairment on the pharmacokinetics and safety profile of dapagliflozin: an open-label, parallel-group, single-dose study. Clin Ther. 2011;33(11):1798–1808.
20. Macha S, Rose P, Mattheus M, et al. Pharmacokinetics, safety and tolerability of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with hepatic impairment [published online ahead of print 2013]. Diabetes Obes Metab.
21. Michitaka K, Nishiguchi S, Aoyagi Y, Hiasa Y, Tokumoto Y, Onji M. Etiology of liver cirrhosis in Japan: a nationwide survey. J Gastroenterol. 2010;45(1):86–94.
22. Bell BP, Manos MM, Zaman A, et al. The epidemiology of newly diagnosed chronic liver disease in gastroenterology practices in the United States: results from population-based surveillance. Am J Gastroenterol. 2008;103(11):2727–2736.
23. Fleming KM, Aithal GP, Solaymani-Dodaran M, Card TR, West J. Incidence and prevalence of cirrhosis in the United Kingdom, 1992-2001: a general population-based study. J Hepatol. 2008;49(5):732–738.
24. Komoroski B, Vachharajani N, Feng Y, et al. Dapagliflozin, a novel SGLT2 inhibitor, induces dose-dependent glucosuria in healthy subjects. Clin Pharmacol Ther. 2009;85(5):520–526.