Safety and effectiveness of tofogliflozin in Japanese people with type 2 diabetes: A multicenter prospective observational study in routine clinical practice

Author:

Yamada Yuichiro123ORCID,Yabe Daisuke1245ORCID,Shide Kenichiro16,Suzuki Atsushi17,Terauchi Yasuo18,Sato Yasunori9,Shihara Nobuyuki1,Seino Yutaka123ORCID

Affiliation:

1. Japan Association for Diabetes Education and Care Tokyo Japan

2. Yutaka Seino Distinguished Center for Diabetes Research Kansai Electric Power Medical Research Institute Kyoto Japan

3. Kansai Electric Power Hospital Osaka Japan

4. Department of Diabetes, Endocrinology and Metabolism and Department of Rheumatology and Clinical Immunology Gifu University Graduate School of Medicine Gifu Japan

5. Center for One Medicine Innovative Translational Research Gifu University Gifu Japan

6. Department of Metabolism and Clinical Nutrition Kyoto University Hospital Kyoto Japan

7. Department of Endocrinology, Diabetes and Metabolism Fujita Health University Toyoake Japan

8. Department of Endocrinology and Metabolism Yokohama City University Graduate School of Medicine Yokohama Japan

9. Department of Preventive Medicine and Public Health Keio University School of Medicine Tokyo Japan

Abstract

ABSTRACTAims/IntroductionSodium–glucose cotransporter 2 (SGLT2) inhibitors effectively and safely reduce fasting and postprandial hyperglycemia while promoting weight loss. However, their unique mechanism of action contributes to concerns regarding their safety. We therefore carried out a large‐scale, non‐commercial, investigator‐initiated study on the safety and effectiveness of the SGLT2 inhibitor tofogliflozin.Materials and MethodsThis multicenter, open‐label, uncontrolled, prospective observational study was carried out at hospitals and clinics across Japan in participants aged ≥20 years who were SGLT2 inhibitor‐naïve and had an established diagnosis of type 2 diabetes. The primary endpoint was adverse drug reactions (ADRs) of special interest. Secondary endpoints included all other ADRs and adverse events, glycated hemoglobin (HbA1c), and weight loss.ResultsThe study, carried out from June 2014 through February 2020, enrolled 11,480 participants from 1,103 medical institutions; 6,967 participants completed the 104‐week follow up. The most common ADRs of special interest were urinary and genital tract infections (1.53%), followed by volume depletion (1.25%). Hypoglycemia occurred in 27 participants (0.24%), adverse events in 1,054 (9.18%) and ADRs in 645 (5.62%). HbA1c decreased by 0.85% (95% confidence interval 0.82%–0.88%) and bodyweight decreased by 3.05 kg (95% confidence interval 2.94–3.17 kg). The HbA1c target was achieved by 51.70% of participants for target HbA1c <7.0%, 85.3% for <8.0% and 5.4% for <6.0% at week 104.ConclusionsTofogliflozin was associated with only mild or moderate ADRs characteristic of SGLT2 inhibitors, with no unpredictable, new, serious, or high‐incidence adverse events or ADRs. This independent study confirmed the safety and effectiveness of tofogliflozin in adult type 2 diabetes patients.

Funder

Kowa Company

Publisher

Wiley

Reference23 articles.

1. Japan Diabetes Clinical Data Management Study Group.Basic study data in 2021. Available from:http://jddm.jp/public‐information/index‐2021/. Accessed November 9 2023.

2. Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

3. Effects of SGLT2 Inhibitors on Kidney and Cardiovascular Function

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