Sodium glucose co-transporter 2 inhibitor luseogliflozin in the management of type 2 diabetes: a drug safety evaluation

ABSTRACT

Introduction: Sodium glucose co-transporter-2 (SGLT2) inhibitors have been developed recently as a new class of anti-diabetic drug, and are becoming widely used in the management of type 2 diabetes (T2D). As these agents have a considerably different glucose-lowering mechanism from those of other anti-diabetic drugs, safe use of this drug class needs to be discussed based on data available from preapproval clinical trials as well as real-world studies. The SGLT2 inhibitor luseogliflozin was developed by Taisho Pharmaceutical Co., Ltd. and was approved as an oral anti-diabetic drug for T2D in Japan

Areas covered: The overall safety and efficacy of SGLT2 inhibitor luseogliflozin are summarized on the basis of a literature review, with a focus on reported adverse drug reactions in preapproval clinical trials and a post-marketing surveillance.

Expert opinion: SGLT2 inhibitor luseogliflozin is well tolerated, significantly improves hyperglycemia in preapproval clinical trials, and has a favorable safety profile in both preapproval clinical trials and post-marketing surveillance in elderly patients. While long-term safety and efficacy remain to be seen, luseogliflozin can benefit T2D patients worldwide. However, healthcare professionals must perform appropriate patient education that includes temporary withdrawal of luseogliflozin during patient a ‘sick day’ and avoidance of strict carbohydrate restriction during luseogliflozin treatment.

KEYWORDS:

• Drug safety
• luseogliflozin
• sodium glucose co-transporter 2 inhibitors
• type 2 diabetes

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Acknowledgements

The authors are especially grateful to Mss. R. Nishikino, N. Yamanaka, C. Ito of Japan Medical Data Centre Co., Ltd for sharing pharmacovigilance data on SGLT2 inhibitors. The authors also thank Ms. M. Yamane, Mr. H. Abe of Kansai Electric Power Hospital for their support. Editorial assistance was provided by Taisho Toyama Pharmaceutical Co., Ltd. Taisho Toyama provided advice on the review and input to drafts.

Declaration of interest

D. Yabe received consulting and/or speaker fees from Novo Nordisk Pharma Ltd. D. Yabe also received clinical commissioned/joint research grants from Nippon Boehringer Ingelheim Co., Ltd., Eli Lilly and Company, Taisho Toyama Pharmaceutical Co. Ltd. and MSD K.K. Y. Hamamoto received consulting and/or speaker fee from Novo Nordisk Pharma Ltd. T. Kurose received consulting and/or speaker fees from Sanofi K.K. T. Kurose also received clinical commissioned/joint research grants from the Japan vascular disease research foundation. Yut. Seino received consulting and/or speaker fees from Eli Lilly Japan K.K., Sanofi K.K., Novo Nordisk Pharma Inc., Glaxo-Smith-Kline, Taisho Pharmaceutical Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Astellas Pharma Inc., BD, Nippon Boehringer Ingelheim Co., Ltd., Johnson & Johnson and Takeda Pharmaceutical Company Limited. Yut. Seino also received clinical commissioned/joint research grants from Taisho Toyama Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Eli Lilly and MSD, K.K. Yus. Seino and H. Kuwata report no conflict of interest relevant to this study. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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Funding

The authors receive Grants-in-Aid for Scientific Research from the Japan Society for Promotion of Science, Grants for Young Researchers from the Japan Association for Diabetes Education and Care, and Grants from the Japan Vascular Disease Research Foundation.