SGLT2 inhibitors in the pipeline for the treatment of diabetes mellitus in Japan

ABSTRACT

Introduction: Sodium glucose cotransporter 2 (SGLT2) inhibitors have been available for the treatment of type 2 diabetes (T2DM) in Japan since April 2014. The prescription rate in Japan is low in comparison to Western countries. We summarize the results obtained from the phase 3 clinical trials and clinical studies involving Japanese T2DM patients. We also discuss the current situation and the future prospects of SGLT2 inhibitors in Japan.

Areas covered: Unexpected adverse events, such as cerebral infarction and diabetic ketoacidosis have been reported from clinics shortly after the initiation of SGLT2 inhibitor treatment. However, the reductions in blood glucose levels and body weight have been demonstrated in phase 3 trials using 6 types of SGLT2 inhibitors, while observational studies of Japanese T2DM patients, which were performed in the clinical setting, showed that the incidence of adverse drug reactions, such as severe hypoglycemia, was low.

Expert opinion: SGLT2 inhibitors are also considered to be effective for treating Japanese patients with T2DM. When prescribing SGLT2 inhibitors, it is necessary to ensure that they are used appropriately because the Japanese T2DM patient population has a high proportion of elderly individuals and a high incidence of cerebrovascular disease.

KEYWORDS:

• Sodium glucose cotransporter 2 inhibitors
• Japanese
• obesity
• weight reduction
• ipragliflozin
• dapagliflozin
• luseogliflozin
• tofogliflozin
• canagliflozin
• empagliflozin

Article highlights

• In Japan, sodium glucose cotransporter 2 (SGLT2) inhibitors have been available for the treatment of type 2 diabetes (T2DM) since April 2014. However, the rate at which SGLT2 inhibitors are prescribed in Japan is still limited in comparison to the U.S. and European countries

• The Japanese T2DM patient population includes a high proportion of elderly subjects and has a high incidence of cerebrovascular disease.

• Some unexpected adverse events, such as cerebral infarction and diabetic ketoacidosis have been reported shortly after the initiation of SGLT2 inhibitor treatment in clinics that treat Japanese T2DM patients.

• Reductions in the blood glucose level and body weight were demonstrated in phase 3 trials of SGLT2 inhibitors, while observational studies that were performed in the clinical setting reported that the frequency of adverse drug reactions, such as severe hypoglycemia, was low in Japanese T2DM patients.

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Acknowledgments

The authors thank Tomoko Koyanagi in the secretarial section of Edogawa Hospital for her valuable help with data collection.

Declaration of interest

The authors have no 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

This paper was not funded