References
- Gallo LA, Wright EM, Vallon V. Probing SGLT2 as a therapeutic target for diabetes: basic physiology and consequences. Diab Vasc Dis Res. 2015 Mar;12(2):78–89.
- Frampton JE. Empagliflozin: a review in type 2 diabetes. Drugs. 2018 Jul;78(10):1037–1048.
- Heise T, Jordan J, Wanner C, et al. Pharmacodynamic effects of single and multiple doses of empagliflozin in patients with type 2 diabetes. Clin Ther. 2016 Oct;38(10):2265–2276.
- Davies MJ, D’Alessio DA, Fradkin J, et al. Management of hyperglycemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018 Dec;41(12):2669–2701.
- Araki E, Goto A, Kondo T, et al. Japanese Clinical Practice Guideline for Diabetes 2019. J Diabetes Investig. 2020 Jul;11(4):1020–1076.
- Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015 Nov 26 373(22):2117–2128.
- Wanner C, Inzucchi SE, Lachin JM, et al. Empagliflozin and progression of kidney disease in type 2 diabetes. N Engl J Med. 2016 Jul 28 375(4):323–334.
- Kaku K, Lee J, Mattheus M, et al. Empagliflozin and cardiovascular outcomes in Asian patients with type 2 diabetes and established cardiovascular disease - results from EMPA-REG OUTCOME. Circ J. 2017 Jan 25 81(2):227–234.
- Kadowaki T, Nangaku M, Hantel S, et al. Empagliflozin and kidney outcomes in Asian patients with type 2 diabetes and established cardiovascular disease: results from the EMPA-REG OUTCOME((R)) trial. J Diabetes Investig. 2019 May;10(3):760–770.
- Kaku K, Wanner C, Anker SD, et al. The effect of empagliflozin on the total burden of cardiovascular and hospitalization events in the Asian and non-Asian populations of the EMPA-REG OUTCOME trial of patients with type 2 diabetes and cardiovascular disease. Diabetes Obes Metab 2022 Apr; 24(4):662–674.
- Patorno E, Pawar A, Franklin JM, et al. Empagliflozin and the risk of heart failure hospitalization in routine clinical care. Circulation. 2019 Jun 18 139(25):2822–2830.
- Patorno E, Pawar A, Wexler DJ, et al. Effectiveness and safety of empagliflozin in routine care patients: results from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study. Diabetes Obes Metab. 2022 Mar;24(3): 442–454. DOI:10.1111/dom.14593. .
- Seino Y, Kim DJ, Yabe D, et al. Cardiovascular and renal effectiveness of empagliflozin in routine care in East Asia: results from the EMPRISE East Asia study. Endocrinol Diabetes Metab. 2021 Jan;4(1):e00183.
- Sheu WH, Seino Y, Tan EC, et al. Healthcare resource utilization in patients treated with empagliflozin in East Asia. J Diabetes Investig. 2021. 10.1111/jdi.13728. Online ahead of print Dec 3.
- 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.
- Neal B, Perkovic V, Mahaffey KW, et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med. 2017 Aug 17 377(7):644–657.
- 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 Jul 18 136(3):249–259.
- Kinduryte Schorling O, Clark D, Zwiener I, et al. Pooled safety and tolerability analysis of empagliflozin in patients with type 2 diabetes mellitus. Adv Ther. 2020 Aug;37(8):3463–3484.
- Yabe D, Yasui A, Ji L, et al. Safety and tolerability of empagliflozin in East Asian patients with type 2 diabetes: pooled analysis of phase I-III clinical trials. J Diabetes Investig. 2019 Mar;10(2):418–428.
- Ma RC, Chan JC. Type 2 diabetes in East Asians: similarities and differences with populations in Europe and the United States. Ann N Y Acad Sci. 2013 Apr;1281(1):64–91.
- Ministry of Health, Labour, and Welfare, Japan. Summary of Patient Survey 2017 [Accessed 2021 Aug 16]. Available from: https://www.mhlw.go.jp/toukei/saikin/hw/kanja/17/dl/toukei.pdf
- Kaku K, Chin R, Naito Y, et al. Safety and effectiveness of empagliflozin in Japanese patients with type 2 diabetes: interim analysis from a post-marketing surveillance study. Expert Opin Drug Saf. 2020 Feb;19(2):211–221.
- Matsuo S, Imai E, Horio M, et al. Revised equations for estimated GFR from serum creatinine in Japan. Am J Kidney Dis. 2009 Jun;53(6):982–992.
- Nippon Boehringer Ingelheim. Jardiance (empagliflozin) Japanese package insert. [cited 2021 Jul 21]. Available at: https://www.pmda.go.jp/
- Shiba T, Ishii S, Okamura T, et al. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: a sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169–178.
- Kohler S, Zeller C, Iliev H, et al. Safety and tolerability of empagliflozin in patients with type 2 diabetes: pooled analysis of phase I-III clinical trials. Adv Ther. 2017 Jul;34(7):1707–1726.
- Committee on the Proper Use of SGLT2 Inhibitors. Recommendations on the proper use of SGLT2 inhibitors. J Diabetes Investig. 2020 Jan;11(1):257–261.
- Yasui A, Lee G, Hirase T, et al. Empagliflozin induces transient diuresis without changing long-term overall fluid balance in Japanese patients with type 2 diabetes. Diabetes Ther. 2018 Apr;9(2):863–871.
- Hirayama A, Torimoto K, Mastusita C, et al. Evaluation of factors influencing the natural history of nocturia in elderly subjects: results of the Fujiwara-kyo Study. J Urol. 2013 Mar;189(3):980–986.
- Suekane S, Ueda K, Suyama S, et al. Comprehensive health-related quality of life is influenced by nocturia and sleep disturbance: investigation based on the SF-8. Kurume Med J. 2016;62(1–2):9–16.
- Inzucchi SE, Iliev H, Pfarr E, et al. Empagliflozin and assessment of lower-limb amputations in the EMPA-REG OUTCOME trial. Diabetes Care. 2018 Jan;41(1):e4–e5.
- Iwase M, Fujii H, Nakamura U, et al. Incidence of diabetic foot ulcer in Japanese patients with type 2 diabetes mellitus: the Fukuoka diabetes registry. Diabetes Res Clin Pract. 2018 Mar;137:183–189.
- Ferrannini E, Baldi S, Frascerra S, et al. Shift to fatty substrate utilization in response to sodium-glucose cotransporter 2 inhibition in subjects without diabetes and patients with type 2 diabetes. Diabetes. 2016 May;65(5):1190–1195.
- Nishimura R, Tanaka Y, Koiwai K, et al. Effect of empagliflozin on free fatty acids and ketone bodies in Japanese patients with type 2 diabetes mellitus: a randomized controlled trial. Adv Ther. 2019 Oct;36(10):2769–2782.
- Tanizaki Y, Kiyohara Y, Kato I, et al. Incidence and risk factors for subtypes of cerebral infarction in a general population: the Hisayama study. Stroke. 2000 Nov;31(11):2616–2622.
- Ohta Y, Takao Y, Harada K, et al. Metabolic syndrome is a risk factor for acute cerebral infarction in a younger elderly Kurashiki population. J Stroke Cerebrovasc Dis. 2012 Apr;21(3):231–239.
- Zinman B, Inzucchi SE, Lachin JM, et al. Empagliflozin and cerebrovascular events in patients with type 2 diabetes mellitus at high cardiovascular risk. Stroke. 2017 May;48(5):1218–1225.
- McGuire DK, Zinman B, Inzucchi SE, et al. Effects of empagliflozin on first and recurrent clinical events in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a secondary analysis of the EMPA-REG OUTCOME trial. Lancet Diabetes Endocrinol. 2020 Dec;8(12):949–959.
- Imai E, Horio M, Watanabe T, et al. Prevalence of chronic kidney disease in the Japanese general population. Clin Exp Nephrol. 2009 Dec;13(6):621–630.
- Monteiro P, Bergenstal RM, Toural E, et al. Efficacy and safety of empagliflozin in older patients in the EMPA-REG OUTCOME(R) trial. Age Ageing. 2019 Nov 1 48(6):859–866.
- Kraus BJ, Weir MR, Bakris GL, et al. Characterization and implications of the initial estimated glomerular filtration rate ‘dip’ upon sodium-glucose cotransporter-2 inhibition with empagliflozin in the EMPA-REG OUTCOME trial. Kidney Int. 2021 Mar;99(3):750–762.
- Abdul-Ghani MA, Norton L, DeFronzo RA. Renal sodium-glucose cotransporter inhibition in the management of type 2 diabetes mellitus. Am J Physiol Renal Physiol. 2015 Dec 1; 309(11):F889–900.
- Sargeant JA, Henson J, King JA, et al. A review of the effects of glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter 2 inhibitors on lean body mass in humans. Endocrinol Metab (Seoul). 2019 Sep;34(3):247–262.
- Sasaki T, Sugawara M, Fukuda M. Sodium-glucose cotransporter 2 inhibitor-induced changes in body composition and simultaneous changes in metabolic profile: 52-week prospective LIGHT (Luseogliflozin: the Components of Weight Loss in Japanese Patients with Type 2 Diabetes Mellitus) Study. J Diabetes Investig. 2019 Jan;10(1):108–117.
- Yabe D, Shiki K, Suzaki K, et al. Rationale and design of the EMPA-ELDERLY trial: a randomised, double-blind, placebo-controlled, 52-week clinical trial of the efficacy and safety of the sodium-glucose cotransporter-2 inhibitor empagliflozin in elderly Japanese patients with type 2 diabetes. BMJ Open. 2021 Apr 7;11(4):e045844.
- Chilton R, Tikkanen I, Cannon CP, et al. Effects of empagliflozin on blood pressure and markers of arterial stiffness and vascular resistance in patients with type 2 diabetes. Diabetes Obes Metab. 2015 Dec;17(12):1180–1193.
- Striepe K, Jumar A, Ott C, et al. Effects of the selective sodium-glucose cotransporter 2 inhibitor empagliflozin on vascular function and central hemodynamics in patients with type 2 diabetes mellitus. Circulation. 2017 Sep 19 136(12):1167–1169.
- Lunder M, Janic M, Japelj M, et al. Empagliflozin on top of metformin treatment improves arterial function in patients with type 1 diabetes mellitus. Cardiovasc Diabetol. 2018 Dec 3 17(1):153.
- Cherney DZ, Perkins BA, Soleymanlou N, et al. The effect of empagliflozin on arterial stiffness and heart rate variability in subjects with uncomplicated type 1 diabetes mellitus. Cardiovasc Diabetol. 2014 Jan 29 13(1):28.
- Kadowaki T, Haneda M, Inagaki N, et al. Efficacy and safety of empagliflozin monotherapy for 52 weeks in Japanese patients with type 2 diabetes: a randomized, double-blind, parallel-group study. Adv Ther. 2015 Apr;32(4):306–318.
- Sone H, Kaneko T, Shiki K, et al. Efficacy and safety of empagliflozin as add-on to insulin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2020 Mar;22(3):417–426.
- Terauchi Y, Utsunomiya K, Yasui A, et al. Safety and efficacy of empagliflozin as add-on therapy to GLP-1 receptor agonist (liraglutide) in Japanese patients with type 2 diabetes mellitus: a randomised, double-blind, parallel-group phase 4 study. Diabetes Ther. 2019 Jun;10(3):951–963.
- Kawamori R, Haneda M, Suzaki K, et al. Empagliflozin as add-on to linagliptin in a fixed-dose combination in Japanese patients with type 2 diabetes: glycaemic efficacy and safety profile in a 52-week, randomized, placebo-controlled trial. Diabetes Obes Metab. 2018 Sep;20(9):2200–2209.
- Araki E, Tanizawa Y, Tanaka Y, et al. Long-term treatment with empagliflozin as add-on to oral antidiabetes therapy in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2015 Jul;17(7):665–674.