Abstract | AIMS/INTRODUCTION:
Tofogliflozin is a potent and highly selective sodium- glucose cotransporter 2 inhibitor, and is currently used to treat patients with type 2 diabetes mellitus. We designed a 3-year study of tofogliflozin in patients with type 2 diabetes mellitus to evaluate the safety and effectiveness in routine clinical practice. The 3- and 12-month interim analysis showed tofogliflozin was well-tolerated, safe and clinically effective. Here, we report the results of the 24-month interim analysis. MATERIALS AND METHODS: This is a 3-year prospective, observational and multicenter post-marketing study (Japanese Study of Tofogliflozin with Type 2 Diabetes Mellitus Patients/Long Term). RESULTS: Of the 6,897 patients enrolled, 6,712 and 6,461 patients were analyzed for the safety and effectiveness of tofogliflozin, respectively. During the 24-month observation period, the incidence rates of adverse drug reactions (ADRs) and serious adverse drug reactions were 11.25 and 1.21%, respectively. As to adverse drug reactions of special interest, the incidence rates of hypoglycemia, polyuria/pollakiuria, volume depletion-related events, urinary tract infections and genital infection were 0.83, 1.28, 1.46, 1.18 and 1.62%, respectively. Renal disorders, and cardiovascular and cerebrovascular disorders occurred in 0.63 and 0.76% of the patients, respectively. Glycated hemoglobin A1c and bodyweight decreased significantly by -0.70% (P < 0.0001) and -2.95 kg (P < 0.0001), respectively, from baseline to week 104 (last observation carried forward). CONCLUSIONS: Significant safety concerns have not been observed, and clinical benefit including a long-term reduction in glycated hemoglobin A1c over a 104-week (24 months) observation period with weight loss was suggested in this 24-month interim analysis of the 3-year Japanese Study of Tofogliflozin with Type 2 Diabetes Mellitus Patients/Long Term in routine clinical practice.
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Authors | Kazunori Utsunomiya, Seigo Kakiuchi, Masayuki Senda, Shoko Fujii, Yuji Kurihara, Ryoji Gunji, Ryusuke Koshida, Hiroyuki Kameda, Masahiro Tamura, Kohei Kaku |
Journal | Journal of diabetes investigation
(J Diabetes Investig)
Vol. 11
Issue 4
Pg. 906-916
(Jul 2020)
ISSN: 2040-1124 [Electronic] Japan |
PMID | 32034997
(Publication Type: Journal Article, Multicenter Study, Observational Study)
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Copyright | © 2020 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd. |
Chemical References |
- Benzhydryl Compounds
- Glucosides
- Glycated Hemoglobin A
- Sodium-Glucose Transporter 2 Inhibitors
- hemoglobin A1c protein, human
- 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol
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Topics |
- Aged
- Benzhydryl Compounds
(therapeutic use)
- Diabetes Mellitus, Type 2
(blood, drug therapy)
- Female
- Glucosides
(therapeutic use)
- Glycated Hemoglobin
(drug effects)
- Humans
- Japan
- Male
- Middle Aged
- Product Surveillance, Postmarketing
- Prospective Studies
- Sodium-Glucose Transporter 2 Inhibitors
(therapeutic use)
- Treatment Outcome
- Weight Loss
(drug effects)
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