281
Views
4
CrossRef citations to date
0
Altmetric
Drug Evaluation

An evaluation of the efficacy and safety of Tofogliflozin for the treatment of type II diabetes

&
Pages 781-790 | Received 25 Nov 2018, Accepted 12 Feb 2019, Published online: 05 Mar 2019

References

  • International Diabetes Foundation. https://www.idf.org/.
  • Group AC, Patel A, MacMahon S, et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358(24):2560–2572.
  • Duckworth W, Abraira C, Moritz T, et al. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med. 2009;360(2):129–139.
  • Action to Control Cardiovascular Risk in Diabetes Study Group, Gerstein HC, Miller ME, et al. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008;358(24):2545–2559.
  • Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373(22):2117–2128.
  • Guthrie R. Canagliflozin and cardiovascular and renal events in type 2 diabetes. Postgrad Med. 2018;130(2):149–153.
  • Wiviott SD, Raz I, Bonaca MP, et al. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2019 Jan 24;380(4):347–357.
  • Kanai Y, Lee WS, You G, et al. The human kidney low affinity Na+/glucose cotransporter SGLT2. Delineation of the major renal reabsorptive mechanism for D-glucose. J Clin Invest. 1994;93(1):397–404.
  • Wright EM, Loo DD, Hirayama BA. Biology of human sodium glucose transporters. Physiol Rev. 2011;91(2):733–794.
  • Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American diabetes association and the European association for the study of diabetes. Diabetes Care. 2015;38(1):140–149.
  • American Diabetes A. Executive summary: standards of medical care in diabetes–2014. Diabetes Care. 2014;37(Suppl 1):S5–S13.
  • Ninomiya T, Perkovic V, de Galan BE, et al. Albuminuria and kidney function independently predict cardiovascular and renal outcomes in diabetes. J Am Soc Nephrol. 2009;20(8):1813–1821.
  • Cherney DZ, Perkins BA, Soleymanlou N, et al. Renal hemodynamic effect of sodium-glucose cotransporter 2 inhibition in patients with type 1 diabetes mellitus. Circulation. 2014;129(5):587–597.
  • Ojima A, Matsui T, Nishino Y, et al. Empagliflozin, an inhibitor of sodium-glucose cotransporter 2 exerts anti-inflammatory and antifibrotic effects on experimental diabetic nephropathy partly by suppressing AGEs-receptor axis. Horm Metab Res. 2015;47(9):686–692.
  • Panchapakesan U, Pegg K, Gross S, et al. Effects of SGLT2 inhibition in human kidney proximal tubular cells–renoprotection in diabetic nephropathy? PLoS One. 2013;8(2):e54442.
  • Salim HM, Fukuda D, Yagi S, et al. Glycemic control with ipragliflozin, a novel selective SGLT2 inhibitor, ameliorated endothelial dysfunction in streptozotocin-induced diabetic mouse. Front Cardiovasc Med. 2016;3:43.
  • Dekkers CCJ, Petrykiv S, Laverman GD, et al. Effects of the SGLT-2 inhibitor dapagliflozin on glomerular and tubular injury markers. Diabetes Obes Metab. 2018;20(8):1988–1993.
  • American Diabetes A. 15. Diabetes advocacy: standards of medical care in diabetes-2018. Diabetes Care. 2018;41(Suppl 1):S152–S153.
  • Zaccardi F, Webb DR, Htike ZZ, et al. Efficacy and safety of sodium-glucose co-transporter-2 inhibitors in type 2 diabetes mellitus: systematic review and network meta-analysis. Diabetes Obes Metab. 2016;18(8):783–794.
  • Ferrannini E, Ramos SJ, Salsali A, et al. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care. 2010;33(10):2217–2224.
  • Cefalu WT, Leiter LA, Yoon KH, et al. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 2013;382(9896):941–950.
  • Liu JJ, Lee T, DeFronzo RA. Why do SGLT2 inhibitors inhibit only 30–50% of renal glucose reabsorption in humans? Diabetes. 2012;61(9):2199–2204.
  • Blonde L, Stenlof K, Fung A, et al. Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks. Postgrad Med. 2016;128(4):371–380.
  • Bolinder J, Ljunggren O, Kullberg J, et al. Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin. J Clin Endocrinol Metab. 2012;97(3):1020–1031.
  • Liu J, Fox CS, Hickson DA, et al. Impact of abdominal visceral and subcutaneous adipose tissue on cardiometabolic risk factors: the Jackson heart study. J Clin Endocrinol Metab. 2010;95(12):5419–5426.
  • Baker WL, Smyth LR, Riche DM, et al. Effects of sodium-glucose co-transporter 2 inhibitors on blood pressure: a systematic review and meta-analysis. J Am Soc Hypertens. 2014;8(4):262–75 e9.
  • Mikhail N. Safety of canagliflozin in patients with type 2 diabetes. Curr Drug Saf. 2014;9(2):127–132.
  • Zinman B, Lachin JM, Inzucchi SE. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2016;374(11):1094.
  • Ahmadieh H, Azar S. Effects of Sodium Glucose Cotransporter-2 Inhibitors on Serum Uric Acid in Type 2 Diabetes Mellitus. Diabetes Technol Ther. 2017;19(9):507–512.
  • Chino Y, Samukawa Y, Sakai S, et al. SGLT2 inhibitor lowers serum uric acid through alteration of uric acid transport activity in renal tubule by increased glycosuria. Biopharm Drug Dispos. 2014;35(7):391–404.
  • Puckrin R, Saltiel MP, Reynier P, et al. SGLT-2 inhibitors and the risk of infections: a systematic review and meta-analysis of randomized controlled trials. Acta Diabetol. 2018;55(5):503–514.
  • Sharma PV, Jobanputra YB, Lewin K, et al. Diabetic ketoacidosis in patients with type 2 diabetes on sodium-glucose cotransporter-2 inhibitors - a case series. Rev Recent Clin Trials. 2018;13(2):156–160.
  • Ahmed M, McKenna MJ, Crowley RK. Diabetic ketoacidosis in patients with type 2 diabetes recently commenced on SGLT-2 inhibitors: an ongoing concern. Endocr Pract. 2017;23(4):506–508.
  • Burke KR, Schumacher CA, Harpe SE. SGLT2 inhibitors: a systematic review of diabetic ketoacidosis and related risk factors in the primary literature. Pharmacotherapy. 2017;37(2):187–194.
  • Zelniker TA, Wiviott SD, Raz I, et al. SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials. Lancet. 2019 Jan 5;393(10166):31–39.
  • Nadkarni GN, Ferrandino R, Chang A, et al. Acute kidney injury in patients on SGLT2 inhibitors: a propensity-matched analysis. Diabetes Care. 2017;40(11):1479–1485.
  • Maranghi M, Carnovale A, Durante C, et al. Pharmacokinetics, pharmacodynamics and clinical efficacy of dapagliflozin for the treatment of type 2 diabetes. Expert Opin Drug Metab Toxicol. 2015;11(1):125–137.
  • Tomlinson B, Hu M, Zhang Y, et al. Evaluation of the pharmacokinetics, pharmacodynamics and clinical efficacy of empagliflozin for the treatment of type 2 diabetes. Expert Opin Drug Metab Toxicol. 2017;13(2):211–223.
  • Hu J, Deng A, Zhao Y. Ertugliflozin as a monotherapy for the treatment of type 2 diabetes. Expert Opin Pharmacother. 2018;19(16):1841–1847.
  • Poole RM, Prossler JE. Tofogliflozin: first global approval. Drugs. 2014;74(8):939–944.
  • Plosker GL. Canagliflozin: a review of its use in patients with type 2 diabetes mellitus. Drugs. 2014;74(7):807–824.
  • Rieg T, Masuda T, Gerasimova M, et al. Increase in SGLT1-mediated transport explains renal glucose reabsorption during genetic and pharmacological SGLT2 inhibition in euglycemia. Am J Physiol Renal Physiol. 2014;306(2):F188–F193.
  • Polidori D, Sha S, Mudaliar S, et al. Canagliflozin lowers postprandial glucose and insulin by delaying intestinal glucose absorption in addition to increasing urinary glucose excretion: results of a randomized, placebo-controlled study. Diabetes Care. 2013;36(8):2154–2161.
  • Kosiborod M, Cavender MA, Fu AZ, et al. Lower risk of heart failure and death in patients initiated on sodium-glucose cotransporter-2 inhibitors versus other glucose-lowering drugs: the CVD-REAL study (comparative effectiveness of cardiovascular outcomes in new users of sodium-glucose cotransporter-2 inhibitors). Circulation. 2017;136(3):249–259.
  • Kosiborod M, Lam CSP, Kohsaka S, et al. Cardiovascular events associated with SGLT-2 inhibitors versus other glucose-lowering drugs: the CVD-REAL 2 study. J Am Coll Cardiol. 2018;71(23):2628–2639.
  • Fitchett D. SGLT2 inhibitors in the real world: too good to be true? Lancet Diabetes Endocrinol. 2017;5(9):673–675.
  • Lv B, Xu B, Feng Y, et al. Exploration of O-spiroketal C-arylglucosides as novel and selective renal sodium-dependent glucose co-transporter 2 (SGLT2) inhibitors. Bioorg Med Chem Lett. 2009;19(24):6877–6881.
  • chem.ncbi.nlm.nih.gov/compound/tofogliflozin#section=Tophp. Secondary.
  • Suzuki M, Honda K, Fukazawa M, et al. Tofogliflozin, a potent and highly specific sodium/glucose cotransporter 2 inhibitor, improves glycemic control in diabetic rats and mice. J Pharmacol Exp Ther. 2012;341(3):692–701.
  • Yamaguchi K, Kato M, Suzuki M, et al. In vitro-in vivo correlation of the inhibition potency of sodium-glucose cotransporter inhibitors in rat: a pharmacokinetic and pharmacodynamic modeling approach. J Pharmacol Exp Ther. 2013;345(1):52–61.
  • Nagata T, Fukuzawa T, Takeda M, et al. Tofogliflozin, a novel sodium-glucose co-transporter 2 inhibitor, improves renal and pancreatic function in db/db mice. Br J Pharmacol. 2013;170(3):519–531.
  • Jurczak MJ, Lee HY, Birkenfeld AL, et al. SGLT2 deletion improves glucose homeostasis and preserves pancreatic beta-cell function. Diabetes. 2011;60(3):890–898.
  • Suzuki M, Takeda M, Kito A, et al. Tofogliflozin, a sodium/glucose cotransporter 2 inhibitor, attenuates body weight gain and fat accumulation in diabetic and obese animal models. Nutr Diabetes. 2014;4:e125.
  • Olefsky JM, Glass CK. Macrophages, inflammation, and insulin resistance. Annu Rev Physiol. 2010;72:219–246.
  • Obata A, Kubota N, Kubota T, et al. Tofogliflozin improves insulin resistance in skeletal muscle and accelerates lipolysis in adipose tissue in male mice. Endocrinology. 2016;157(3):1029–1042.
  • Obara K, Shirakami Y, Maruta A, et al. Preventive effects of the sodium glucose cotransporter 2 inhibitor tofogliflozin on diethylnitrosamine-induced liver tumorigenesis in obese and diabetic mice. Oncotarget. 2017;8(35):58353–58363.
  • Kaku K, Watada H, Iwamoto Y, et al. Efficacy and safety of monotherapy with the novel sodium/glucose cotransporter-2 inhibitor tofogliflozin in Japanese patients with type 2 diabetes mellitus: a combined phase 2 and 3 randomized, placebo-controlled, double-blind, parallel-group comparative study. Cardiovasc Diabetol. 2014;13:65.
  • Tanizawa Y, Kaku K, Araki E, et al. Long-term safety and efficacy of tofogliflozin, a selective inhibitor of sodium-glucose cotransporter 2, as monotherapy or in combination with other oral antidiabetic agents in Japanese patients with type 2 diabetes mellitus: multicenter, open-label, randomized controlled trials. Expert Opin Pharmacother. 2014;15(6):749–766.
  • Nagata T, Fukazawa M, Honda K, et al. Selective SGLT2 inhibition by tofogliflozin reduces renal glucose reabsorption under hyperglycemic but not under hypo- or euglycemic conditions in rats. Am J Physiol Endocrinol Metab. 2013;304(4):E414–E423.
  • Ikeda S, Takano Y, Cynshi O, et al. A novel and selective sodium-glucose cotransporter-2 inhibitor, tofogliflozin, improves glycaemic control and lowers body weight in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2015;17(10):984–993.
  • Egan AM, Montori VM. Review: in adults with type 1 diabetes, SGLT-2 inhibitors reduce HbA1c but increase diabetic ketoacidosis. Ann Intern Med. 2018;169(2):JC3.
  • Lucero P, Chapela S. Euglycemic diabetic ketoacidosis in the ICU: 3 case reports and review of literature. Case Rep Crit Care. 2018;2018:1747850.
  • Badwal K, Tariq T, Peirce D. Dapagliflozin-associated euglycemic diabetic ketoacidosis in a patient presenting with acute pancreatitis. Case Rep Endocrinol. 2018;2018:6450563.
  • Peters AL, Buschur EO, Buse JB, et al. Euglycemic diabetic ketoacidosis: a potential complication of treatment with sodium-glucose cotransporter 2 inhibition. Diabetes Care. 2015;38(9):1687–1693.
  • Taylor SI, Blau JE, Rother KI. SGLT2 inhibitors may predispose to ketoacidosis. J Clin Endocrinol Metab. 2015;100(8):2849–2852.
  • Yabe D, Iwasaki M, Kuwata H, et al. Sodium-glucose co-transporter-2 inhibitor use and dietary carbohydrate intake in Japanese individuals with type 2 diabetes: A randomized, open-label, 3-arm parallel comparative, exploratory study. Diabetes Obes Metab. 2017;19(5):739–743.
  • Ferrannini E, Mark M, Mayoux E. CV protection in the EMPA-REG OUTCOME trial: a “thrifty substrate” hypothesis. Diabetes Care. 2016;39(7):1108–1114.
  • Mudaliar S, Alloju S, Henry RR. Can a shift in fuel energetics explain the beneficial cardiorenal outcomes in the EMPA-REG OUTCOME study? A unifying hypothesis. Diabetes Care. 2016;39(7):1115–1122.
  • Utsunomiya K, Shimmoto N, Senda M, et al. Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post-marketing study (J-STEP/EL Study). J Diabetes Investig. 2017;8(6):766–775.
  • Higashikawa T, Ito T, Mizuno T, et al. The effects of 12-month administration of tofogliflozin on electrolytes and dehydration in mainly elderly Japanese patients with type 2 diabetes mellitus. J Int Med Res. 2018 Oct 25;300060518790870.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.