5,677
Views
12
CrossRef citations to date
0
Altmetric
Original Research

Real-World Evidence for Long-Term Safety and Effectiveness of Ipragliflozin in Japanese Patients with Type 2 Diabetes Mellitus: final Results of a 3-Year Post-Marketing Surveillance Study (STELLA-LONG TERM)

, , &
Pages 373-387 | Received 21 Jul 2020, Accepted 27 Aug 2020, Published online: 03 Oct 2020

References

  • Arnott C, Li Q, Kang A, et al. Sodium-glucose cotransporter 2 inhibition for the prevention of cardiovascular events in patients with type 2 diabetes mellitus: a systematic review and meta-analysis. J Am Heart Assoc. 2020;9(3):e014908.
  • Watada H. Current understanding of the effect of sodium–glucose co-transporter-2 inhibitors in Asian patients with diabetes mellitus. Diabetol Int. 2020;11(3):242–244.
  • Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. New Engl J Med. 2019;380(24):2295–2306.
  • Rådholm K, Figtree G, Perkovic V, et al. Canagliflozin and heart failure in type 2 diabetes mellitus: results from the CANVAS program. Circulation. 2018;138(5):458–468.
  • Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. New Engl J Med. 2015;373(22):2117–2128.
  • Cosentino F, Grant PJ, Aboyans V, et al. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the task force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD). Eur Heart J. 2020;41(2):255–323.
  • Dennis JM, Henley WE, McGovern AP, et al. Time trends in prescribing of type 2 diabetes drugs, glycaemic response and risk factors: a retrospective analysis of primary care data, 2010–2017. Diabetes Obes Metab. 2019;21(7):1576–1584.
  • Ito Y, Van Schyndle J, Nishimura T, et al. Characteristics of patients with diabetes initiating sodium glucose co-transporter-2 inhibitors (SGLT2i): real-world results from three administrative databases in Japan. Diabetes Ther. 2019;10(2):549–562.
  • Poole RM, Dungo RT. Ipragliflozin: first global approval. Drugs. 2014;74(5):611–617.
  • Kadokura T, Akiyama N, Kashiwagi A, et al. Pharmacokinetic and pharmacodynamic study of ipragliflozin in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study. Diabetes Res Clin Pract. 2014;106(1):50–56.
  • Kashiwagi A, Akiyama N, Shiga T, et al. Efficacy and safety of ipragliflozin as an add-on to a sulfonylurea in Japanese patients with inadequately controlled type 2 diabetes: results of the randomized, placebo-controlled, double-blind, phase III EMIT study. Diabetol Int. 2015;6(2):125–138.
  • Kashiwagi A, Isaka H, Kawano H, et al. Long-term safety, tolerability and efficacy of ipragliflozin in combination with a dipeptidyl peptidase-4 inhibitor in Japanese patients with type 2 diabetes mellitus inadequately controlled with a dipeptidyl peptidase-4 inhibitor alone - DAYLIGHT study. Jpn Pharmacol Ther. 2014;42:941–952.
  • Kashiwagi A, Isaka H, Nakahama H, et al. Long-term safety, tolerability and efficacy of ipragliflozin in combination with nateglinide in Japanese patients with type 2 diabetes mellitus inadequately controlled with nateglinide alone - CANDLE study. Jpn Pharmacol Ther. 2014;42:959–975.
  • Kashiwagi A, Kazuta K, Goto K, et al. Ipragliflozin in combination with metformin for the treatment of Japanese patients with type 2 diabetes: ILLUMINATE, a randomized, double-blind, placebo-controlled study. Diabetes Obes Metab. 2015;17(3):304–308.
  • Kashiwagi A, Kazuta K, Takinami Y, et al. Ipragliflozin improves glycemic control in Japanese patients with type 2 diabetes mellitus: the BRIGHTEN study. Diabetol Int. 2015;6(1):8–18.
  • Kashiwagi A, Kazuta K, Yoshida S, et al. Randomized, placebo-controlled, double-blind glycemic control trial of novel sodium-dependent glucose cotransporter 2 inhibitor ipragliflozin in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig. 2014;5(4):382–391.
  • Kashiwagi A, Shiga T, Akiyama N, et al. Efficacy and safety of ipragliflozin as an add-on to pioglitazone in Japanese patients with inadequately controlled type 2 diabetes: a randomized, double-blind, placebo-controlled study (the SPOTLIGHT study). Diabetol Int. 2015;6(2):104–116.
  • Kashiwagi A, Takahashi H, Ishikawa H, et al. A randomized, double-blind, placebo-controlled study on long-term efficacy and safety of ipragliflozin treatment in patients with type 2 diabetes mellitus and renal impairment: results of the long-term ASP1941 safety evaluation in patients with type 2 diabetes with renal impairment (LANTERN) study. Diabetes Obes Metab. 2015;17(2):152–160.
  • Kashiwagi A, Isaka H, Takinami Y, et al. Long-term safety and efficacy of ipragliflozin in combination with an α-glucosidase inhibitor in Japanese patients with type 2 diabetes mellitus inadequately controlled with an α-glucosidase inhibitor alone -AGLOW study. Jpn Pharmacol Ther. 2014;42:923–939.
  • Kashiwagi A, Kawano H, Kazuta K, et al. Long-term safety, tolerability and efficacy of ipragliflozin in Japanese patients with type 2 diabetes mellitus -IGNITE study. Jpn Pharmacol Ther. 2015;43:85–100.
  • Maegawa H, Tobe K, Tabuchi H, et al. Baseline characteristics and interim (3-month) efficacy and safety data from STELLA-LONG TERM, a long-term post-marketing surveillance study of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice. Expert Opin Pharmacother. 2016;17(15):1985–1994.
  • Tabuchi H, Maegawa H, Tobe K, et al. Effect of ipragliflozin on liver function in Japanese type 2 diabetes mellitus patients: a subgroup analysis of the STELLA-LONG TERM study (3-month interim results). Endocr J. 2019;66(1):31–41.
  • Nakamura I, Maegawa H, Tobe K, et al. Safety and effectiveness of ipragliflozin for type 2 diabetes in Japan: 12-month interim results of the STELLA-LONG TERM post-marketing surveillance study. Adv Ther. 2019;36(4):923–949.
  • Maegawa H, Tobe K, Nakamura I, et al. Safety and effectiveness of ipragliflozin in elderly versus non-elderly Japanese type 2 diabetes mellitus patients: 12 month interim results of the STELLA-LONG TERM study. Curr Med Res Opin. 2019;35(11):1901–1910.
  • Nakamura I, Tobe K, Maegawa H, et al. Safety and effectiveness of ipragliflozin in Japanese patients with type 2 diabetes mellitus: 24‒month interim results of the STELLA-LONG TERM post-marketing surveillance study. Jpn Pharmacol Ther. 2019;47(11):1765–1789.
  • Tobe K, Maegawa H, Nakamura I, et al. Safety and effectiveness of ipragliflozin in Japanese patients with type 2 diabetes mellitus stratified by body mass index: a subgroup analysis of 24-month interim results from the STELLA-LONG TERM post-marketing surveillance study. Jpn Pharmacol Ther. 2019;47(11):1791–1805.
  • The Committee on the Proper Use of SGLT2 Inhibitors. Recommendations on the proper use of SGLT2 inhibitors. J Diabetes Investig. 2020;11(1):257–261.
  • Araki E, Goto A, Kondo T, et al. Japanese clinical practice guideline for diabetes 2019. Diabetol Int. 2020;11(3):165–223.
  • Ueki K, Sasako T, Okazaki Y, et al. Effect of an intensified multifactorial intervention on cardiovascular outcomes and mortality in type 2 diabetes (J-DOIT3): an open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2017;5(12):951–964.
  • Kashiwagi A, Shestakova MV, Ito Y, et al. Safety of ipragliflozin in patients with type 2 diabetes mellitus: pooled analysis of phase II/III/IV clinical trials. Diabetes Ther. 2019;10(6):2201–2217.
  • Nakamura I, Maegawa H, Tobe K, et al. Safety and efficacy of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice: interim results of the STELLA-LONG TERM post-marketing surveillance study. Expert Opin Pharmacother. 2018;19(3):189–201.
  • Inagaki N, Nangaku M, Sakata Y. et al. Safety and efficacy of canagliflozin, an SGLT2 inhibitor, in patients with type 2 diabetes mellitus: an interim analysis of post-marketing surveillance (SAPPHIRE). J New Rem Clin. 2019;68(1):9–37.
  • 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;19(2):211–221.
  • Utsunomiya K, Senda M, Kakiuchi S, et al. Safety and efficacy of tofogliflozin in Japanese patients with type 2 diabetes mellitus in real-world clinical practice: results of 3-month interim analysis of a long-term post-marketing surveillance study (J-STEP/LT). J Diabetes Invest. 2019;10(5):1272–1283.
  • Yoshida S, Kim H, Takumi Y. Evaluation of safety and efficacy of dapagliflozin in patients with type 2 diabetes: an interim report of a special drug use-results survey for long-term use. Jpn Pharmacol Ther. 2017;45(5):737–762.
  • Ansary TM, Nakano D, Nishiyama A. Diuretic effects of sodium glucose cotransporter 2 inhibitors and their influence on the renin-angiotensin system. Int J Mol Sci. 2019;20(3):629.
  • 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;34(7):1707–1726.
  • Mol A, Bui Hoang PTS, Sharmin S, et al. Orthostatic hypotension and falls in older adults: a systematic review and meta-analysis. J Am Med Dir Assoc. 2019;20(5):589–597.e5.
  • Yabe D, Nishikino R, Kaneko M, et al. Short-term impacts of sodium/glucose co-transporter 2 inhibitors in Japanese clinical practice: considerations for their appropriate use to avoid serious adverse events. Expert Opin Drug Saf. 2015;14(6):795–800.
  • Donnan JR, Grandy CA, Chibrikov E, et al. Comparative safety of the sodium glucose co-transporter 2 (SGLT2) inhibitors: a systematic review and meta-analysis. BMJ Open. 2019;9(1):e022577.
  • Schols JM, De Groot CP, van der Cammen TJ, et al. Preventing and treating dehydration in the elderly during periods of illness and warm weather. J Nutr Health Aging. 2009;13(2):150–157.
  • Asplund R. Nocturia, nocturnal polyuria, and sleep quality in the elderly. J Psychosom Res. 2004;56(5):517–525.
  • Yokote K, Terauchi Y, Nakamura I, et al. Real-world evidence for the safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): final results of a post-marketing surveillance study. Expert Opin Pharmacother. 2016;17(15):1995–2003.
  • Geerlings S, Fonseca V, Castro-Diaz D, et al. Genital and urinary tract infections in diabetes: impact of pharmacologically-induced glucosuria. Diabetes Res Clin Pract. 2014;103(3):373–381.
  • Cherukuri L, Smith MS, Tayek JA. The durability of oral diabetic medications: time to A1c baseline and a review of common oral medications used by the primary care provider. Endocrinol Diabetes Metab J. 2018;2(3):1-4.
  • Bailey CJ, Del Prato S, Wei C, et al. Durability of glycaemic control with dapagliflozin, an SGLT2 inhibitor, compared with saxagliptin, a DPP4 inhibitor, in patients with inadequately controlled type 2 diabetes. Diabetes Obes Metab. 2019;21(11):2564–2569.
  • Tanaka A, Node K. Promising roles of sodium–glucose cotransporter 2 inhibitors in heart failure prevention and treatment. Diabetol Int. 2020;11(3):252–260.
  • Sano M, Goto S. Possible mechanism of hematocrit elevation by sodium glucose cotransporter 2 inhibitors and associated beneficial renal and cardiovascular effects. Circulation. 2019;139(17):1985–1987.
  • Zhao Y, Xu L, Tian D, et al. Effects of sodium-glucose co-transporter 2 (SGLT2) inhibitors on serum uric acid level: a meta-analysis of randomized controlled trials. Diabetes Obes Metab. 2018;20(2):458–462.
  • Inzucchi SE, Zinman B, Fitchett D, et al. How does empagliflozin reduce cardiovascular mortality? Insights from a mediation analysis of the EMPA-REG OUTCOME trial. Diabetes Care. 2018;41(2):356–363.
  • Mooradian AD. Dyslipidemia in type 2 diabetes mellitus. Nat Rev Endocrinol. 2009;5(3):150–159.
  • Bando Y, Tohyama H, Aoki K, et al. Ipragliflozin lowers small, dense low-density lipoprotein cholesterol levels in Japanese patients with type 2 diabetes mellitus. J Clin Transl Endocrinol. 2016;6:1–7.
  • Kashiwagi A, Sakatani T, Nakamura I, et al. Improved cardiometabolic risk factors in Japanese patients with type 2 diabetes treated with ipragliflozin: a pooled analysis of six randomized, placebo-controlled trials. Endocr J. 2018;65(7):693–705.
  • Wiviott SD, Raz I, Bonaca MP, et al. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. New Engl J Med. 2018;380(4):347–357.