Safety and effectiveness of empagliflozin according to body mass index in Japanese patients with type 2 diabetes: a subgroup analysis of a 3-year post-marketing surveillance study

References

• van Dam RM. The epidemiology of lifestyle and risk for type 2 diabetes. Eur J Epidemiol. 2003;18(12):1115–1125.
   PubMed Web of Science ®Google Scholar
• Sun H, Saeedi P, Karuranga S, et al. IDF diabetes Atlas: global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2021;24:109–119.
   Google Scholar
• Karter AJ, Schillinger D, Adams AS, et al. Elevated rates of diabetes in Pacific Islanders and Asian subgroups: the Diabetes Study of Northern California (DISTANCE). Diabetes Care. 2013 Mar;36(3):574–579.
   PubMed Web of Science ®Google Scholar
• Miyazawa I, Kadota A, Miura K, et al. Twelve-year trends of increasing overweight and obesity in patients with diabetes: the Shiga Diabetes Clinical Survey. Endocr J. 2018 May 28;65(5):527–536.
   PubMed Web of Science ®Google Scholar
• Zhou X, Ji L, Ran X, et al. Prevalence of obesity and its influence on achievement of cardiometabolic therapeutic goals in Chinese type 2 diabetes patients: an analysis of the nationwide, cross-sectional 3B study. PLoS One. 2016;11(1):e0144179.
   PubMed Web of Science ®Google Scholar
• Sone H, Ito H, Ohashi Y, et al. Obesity and type 2 diabetes in Japanese patients. Lancet. 2003 Jan 4;361(9351):85.
   PubMed Web of Science ®Google Scholar
• Kubota Y, Iso H, Tamakoshi A, et al. Association of body mass index and mortality in Japanese diabetic men and women based on self-reports: the Japan Collaborative Cohort (JACC) study. J Epidemiol. 2015;25(8): 553–558.
   PubMed Web of Science ®Google Scholar
• Tanaka S, Tanaka S, Iimuro S, et al. Body mass index and mortality among Japanese patients with type 2 diabetes: pooled analysis of the Japan Diabetes Complications Study and the Japanese Elderly Diabetes Intervention Trial. J Clin Endocrinol Metab. 2014 Dec;99(12):E2692–6.
   PubMed Web of Science ®Google Scholar
• Michel MC, Mayoux E, Vallon V. A comprehensive review of the pharmacodynamics of the SGLT2 inhibitor empagliflozin in animals and humans. Naunyn Schmiedebergs Arch Pharmacol. 2015 Aug;388(8):801–816.
   PubMed Web of Science ®Google Scholar
• Frampton JE. Empagliflozin: a review in type 2 diabetes. Drugs. 2018 Jul;78(10):1037–1048.
   PubMed Web of Science ®Google Scholar
• Giaccari A. Sodium-glucose co-transporter inhibitors: medications that mimic fasting for cardiovascular prevention. Diabetes Obes Metab. 2019 Oct;21(10):2211–2218.
   PubMed Web of Science ®Google Scholar
• Barnett AH. Impact of sodium glucose cotransporter 2 inhibitors on weight in patients with type 2 diabetes mellitus. Postgrad Med. 2013 Sep;125(5):92–100.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Kaku K, Yamamoto K, Fukushima Y, et al. Safety and effectiveness of empagliflozin in Japanese patients with type 2 diabetes: final results of a 3-year post-marketing surveillance study. Expert Opin Drug Saf. 2022 Mar 22;1–14. Online ahead of print. doi:10.1080/14740338.2022.2054987.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Huttunen R, Syrjanen J. Obesity and the risk and outcome of infection. Int J Obes (Lond). 2013 Mar;37(3):333–340.
   PubMed Web of Science ®Google Scholar
• Alhabeeb H, Baradwan S, Kord-Varkaneh H, et al. Association between body mass index and urinary tract infection: a systematic review and meta-analysis of observational cohort studies. Eat Weight Disord. 2021 Oct;26(7):2117–2125.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Sasaki T. Sarcopenia, frailty circle and treatment with sodium-glucose cotransporter 2 inhibitors. J Diabetes Investig. 2019 Mar;10(2):193–195.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMedGoogle Scholar
• Ji Q, Ji L, Mu Y, et al. Effect of empagliflozin on cardiorenal outcomes and mortality according to body mass index: a subgroup analysis of the EMPA-REG OUTCOME trial with a focus on Asia. Diabetes Obes Metab. 2021 Aug;23(8):1886–1891.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Boehringer Ingelheim. Data on file.
   Google Scholar
• Wanner C, Heerspink HJL, Zinman B, et al. Empagliflozin and kidney function decline in patients with type 2 diabetes: a slope analysis from the EMPA-REG OUTCOME trial. J Am Soc Nephrol. 2018 Nov;29(11):2755–2769.
   PubMed Web of Science ®Google Scholar
• Pavkov ME, Nelson RG. Estimating GFR in the elderly - new approaches to an old problem. Kidney Int Rep. 2019 Jun;4(6):763–765.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar