Abstract

The safety profiles of sodium-glucose co-transporter 2 (SGLT2) inhibitors may depend on races/ethnicities. We aimed to assess the safety profiles of SGLT2 inhibitors in Japanese patients with diabetes mellitus (DM). The electronic databases MEDLINE, CENTRAL, and Ichushi-web were searched for studies with no language restriction from their inception to August 2019. Trials were included in the analysis if they were randomized controlled trials (RCTs) comparing the effects of SGLT2 inhibitors with a placebo in Japanese patients with DM > 18 years and reporting HbA1c and at least 1 adverse event. We calculated risk ratios with 95% CIs and used a random-effects model. Of the 22 RCTs included in our review, only 1 included patients with type 1 DM. The durations of RCTs ranged between 4 and 24 weeks. In comparison with a placebo, SGLT2 inhibitors were associated with similar risks of hypoglycemia, urinary tract infection, genital infection, hypovolemia, and fracture. The outcomes of treatment with SGLT2 inhibitors among Japanese patients with DM suggest favorable safety profiles. However, further evidence from studies with a longer duration, involving more diverse populations, such as patients with different types of DM, or including individual SGLT2 inhibitors is needed to resolve the limitations of the present study.

Highlights

  • The safety profiles of sodium-glucose co-transporter 2 (SGLT2) inhibitors may depend on races/ ethnicities

  • The results obtained revealed that SGLT2 inhibitors were associated with similar risks of hypoglycemia, urinary tract infection (UTI), genital infection, hypovolemia, and fracture as a placebo

  • The present study demonstrated that SGLT2 inhibitors had a similar risk of UTI [risk ratio 0.78] as a placebo

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Summary

Introduction

The safety profiles of sodium-glucose co-transporter 2 (SGLT2) inhibitors may depend on races/ ethnicities. Sodium-glucose co-transporter 2 (SGLT2) inhibitors are novel oral hypoglycemic agents that exert beneficial effects on glycemic control and weight loss in patients with type 1 and 2 diabetes mellitus (DM)[1,2,3]. Meta-analyses recently showed that the effects of SGLT2 inhibitors on glycemic control and weight loss, and lipid profiles were similar between Asian and non-Asian p­ atients[7,8]. Another study that focused on racial differences found that the risk of cough was higher in East Asian patients who are treated with angiotensinconverting enzyme inhibitors than in Caucasian ­patients[9] Based on these findings, we hypothesized that the safety profiles of SGLT2 inhibitors in patients with DM depend on racial differences. We conducted a systematic review and meta-analysis to summarize the available literature and appraise the safety profiles of SGLT2 inhibitors in Japanese patients with DM

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