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Diabetes

Efficacy and safety of ertugliflozin across racial groups in patients with type 2 diabetes mellitus

, , , , , , , , & ORCID Icon show all
Pages 1277-1284 | Received 01 Nov 2019, Accepted 23 Mar 2020, Published online: 13 May 2020

References

  • Golden SH, Brown A, Cauley JA, et al. Health disparities in endocrine disorders: biological, clinical, and nonclinical factors – an Endocrine Society scientific statement. J Clin Endocrinol Metab. 2012;97(9):E1579–E1639.
  • International Diabetes Federation. IDF diabetes atlas. 8th ed. Brussels (Belgium): International Diabetes Federation; 2017 [cited 2020 May 4]. Available from: https://www.idf.org/e-library/epidemiology-research/diabetes-atlas/134-idf-diabetes-atlas-8th-edition.html
  • Moller JB, Dalla Man C, Overgaard RV, et al. Ethnic differences in insulin sensitivity, beta-cell function, and hepatic extraction between Japanese and Caucasians: a minimal model analysis. J Clin Endocrinol Metab. 2014;99(11):4273–4280.
  • European Medicines Agency. Steglatro (ertugliflozin) summary of product characteristics. Hoddesdon (UK): Merck Sharp & Dohme Ltd; 2018.
  • US Food and Drug Administration. Steglatro (ertugliflozin) prescribing information. Whitehouse Station (NJ): Merck Sharp & Dohme Corp; 2017.
  • Heerspink HJ, Perkins BA, Fitchett DH, et al. Sodium glucose cotransporter 2 inhibitors in the treatment of diabetes mellitus: cardiovascular and kidney effects, potential mechanisms, and clinical applications. Circulation. 2016;134(10):752–772.
  • Kalgutkar AS, Tugnait M, Zhu T, et al. Preclinical species and human disposition of PF-04971729, a selective inhibitor of the sodium-dependent glucose cotransporter 2 and clinical candidate for the treatment of type 2 diabetes mellitus. Drug Metab Dispos. 2011;39(9):1609–1619.
  • Raje S, Callegari E, Sahasrabudhe V, et al. Novel application of the two-period microtracer approach to determine absolute oral bioavailability and fraction absorbed of ertugliflozin. Clin Transl Sci. 2018;11(4):405–411.
  • Terra SG, Focht K, Davies M, et al. Phase III, efficacy and safety study of ertugliflozin monotherapy in people with type 2 diabetes mellitus inadequately controlled with diet and exercise alone. Diabetes Obes Metab. 2017;19(5):721–728.
  • Rosenstock J, Frias J, Pall D, et al. Effect of ertugliflozin on glucose control, body weight, blood pressure and bone density in type 2 diabetes mellitus inadequately controlled on metformin monotherapy (VERTIS MET). Diabetes Obes Metab. 2018;20(3):520–529.
  • Pratley RE, Eldor R, Raji A, et al. Ertugliflozin plus sitagliptin versus either individual agent over 52 weeks in patients with type 2 diabetes mellitus inadequately controlled with metformin: the VERTIS FACTORIAL randomized trial. Diabetes Obes Metab. 2018;20(5):1111–1120.
  • Miller S, Krumins T, Zhou H, et al. Ertugliflozin and sitagliptin co-initiation in patients with type 2 diabetes: The VERTIS SITA randomized study. Diabetes Ther. 2018;9(1):253–268.
  • Dagogo-Jack S, Liu J, Eldor R, et al. Efficacy and safety of the addition of ertugliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sitagliptin: the VERTIS SITA2 placebo-controlled randomized study. Diabetes Obes Metab. 2018;20(3):530–540.
  • Grunberger G, Camp S, Johnson J, et al. Ertugliflozin in patients with stage 3 chronic kidney disease and type 2 diabetes mellitus: the VERTIS RENAL randomized study. Diabetes Ther. 2018;9(1):49–66.
  • Hollander P, Liu J, Hill J, et al. Ertugliflozin compared with glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin: the VERTIS SU randomized study. Diabetes Ther. 2018;9(1):193–207.
  • Liu J, Tarasenko L, Terra SG, et al. Efficacy of ertugliflozin in monotherapy or combination therapy in patients with type 2 diabetes: a pooled analysis of placebo-controlled studies. Diab Vasc Dis Res. 2019;16(6):415–423.
  • Fryar CD, Ostchega Y, Hales CM, et al. Hypertension prevalence and control among adults: United States, 2015–2016. NCHS Data Brief. 2017;(289):1–8.
  • Lindhorst J, Alexander N, Blignaut J, et al. Differences in hypertension between blacks and whites: an overview. Cardiovasc J Afr. 2007;18(4):241–247.
  • Carnethon MR, Pu J, Howard G, et al. Cardiovascular health in African Americans: a scientific statement from the American Heart Association. Circulation. 2017;136(21):e393–e423.
  • Sahasrabudhe V, Terra SG, Hickman A, et al. The effect of renal impairment on the pharmacokinetics and pharmacodynamics of ertugliflozin in subjects with type 2 diabetes mellitus. J Clin Pharmacol. 2017;57(11):1432–1443.
  • Sahasrabudhe V, Fediuk DJ, Matschke K, et al. Effect of food on the pharmacokinetics of ertugliflozin and its fixed-dose combinations ertugliflozin/sitagliptin and ertugliflozin/metformin. Clin Pharmacol Drug Dev. 2019;8(5):619–627.
  • Dawra VK, Cutler DL, Zhou S, et al. Assessment of the drug interaction potential of ertugliflozin with sitagliptin, metformin, glimepiride, or simvastatin in healthy subjects. Clin Pharmacol Drug Dev. 2019;8(3):314–325.
  • Miao Z, Nucci G, Amin N, et al. Pharmacokinetics, metabolism, and excretion of the antidiabetic agent ertugliflozin (PF-04971729) in healthy male subjects. Drug Metab Dispos. 2013;41(2):445–456.
  • Liang Y, Sahasrabudhe V, Tensfeldt T, et al. Meta-analysis of non-compartmental pharmacokinetic parameters to evaluate the effect of UGT1A9 polymorphism on ertugliflozin exposure. J Pharmacokinet Phar. 2018;45(S1):W-066.
  • Li Y, Mu Y, Shi H, et al. Pharmacokinetic properties of single and multiple doses of ertugliflozin, a selective inhibitor of SGLT2, in healthy Chinese subjects. Clin Pharmacol Drug Dev. 2019;9(1):97–106.
  • Li Y, Nucci G, Yamamoto Y, et al. Comparison of pharmacokinetic (PK) and pharmacodynamic (PD) Results of ertugliflozin (ERTU) between Japanese and western healthy subjects. Clin Pharmacol Ther. 2019;105:S1.
  • Ji L, Han P, Liu Y, et al. Canagliflozin in Asian patients with type 2 diabetes on metformin alone or metformin in combination with sulphonylurea. Diabetes Obes Metab. 2015;17(1):23–31.
  • Dave CV, Schneeweiss S, Patorno E. Comparative risk of genital infections associated with sodium–glucose co-transporter-2 inhibitors. Diabetes Obes Metab. 2019;21(2):434–438.
  • Cannon CP, McGuire DK, Pratley R, et al. Design and baseline characteristics of the eValuation of ERTugliflozin effIcacy and Safety CardioVascular outcomes trial (VERTIS-CV). Am Heart J. 2018;206:11–23.
  • Liu J, Patel S, Cater NB, et al. Efficacy and safety of ertugliflozin in East/Southeast Asian patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2020;22(4):574–582.