Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A subanalysis of a post‐marketing study (J‐STEP/EL Study). Issue 2 (5th September 2019)

• Record Type: Journal Article
• Authors: Kaku, Kohei; Naito, Yusuke; Senda, Masayuki; Kurihara, Yuji; Gunji, Ryoji; Kakiuchi, Seigo; Utsunomiya, Kazunori
• Is Part Of: Journal of diabetes investigation. Volume 11:Issue 2(2020)
• Page Start: 405
• Page End: 416
• Publication Date: 2019-09-05
• Subjects: Elderly -- Sodium–glucose transporter 2 -- Type 2 diabetes mellitus; Diabetes -- Periodicals; Diabetes -- Research -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462005
• DOI: 10.1111/jdi.13125
• Languages: English
• ISSNs: 2040-1116

Abstract

Abstract: Aims/Introduction: This subanalysis aimed to assess the safety and effectiveness of tofogliflozin by using data from the Japanese Study of Tofogliflozin with Type 2 Diabetes Mellitus Patients in an Observational Study of the Elderly to categorize elderly Japanese patients with type 2 diabetes mellitus by the number of concomitant oral antidiabetic drugs (OADs) and insulin use at baseline. Materials and Methods: Japanese Study of Tofogliflozin with Type 2 Diabetes Mellitus Patients in an Observational Study of the Elderly is a 1‐year prospective, observational and multicenter post‐marketing study that enrolled all patients with type 2 diabetes mellitus aged ≥65 years who started tofogliflozin during the first 3 months after its launch in May 2014 in Japan. Results: The safety and effectiveness analysis sets included 1, 497 and 1, 422 patients, respectively. Overall, 18.10 and 2.20% of the patients experienced adverse drug reactions (ADRs) and serious ADRs, respectively. ADRs of special interest in the total, 0 OAD, one OAD, two OADs, three or more OADs and insulin groups occurred in 12.22, 10.04, 12.35, 13.32, 11.27 and 14.91% of patients, respectively. Volume depletion‐related events were the most frequently observed ADRs of special interest. Hypoglycemia occurred in 1.07% of patients. Overall, glycated hemoglobin and bodyweight were significantly decreased, but the estimated glomerular filtration rate was not significantly changed. Conclusions: Our finding suggests that tofogliflozin could be safely and effectively used in elderly Japanese patients with type 2 diabetes mellitus, irrespective of the number of OADs and the use of insulin. Abstract : This subanalysis suggests that tofogliflozin could be safely and effectively used in elderly Japanese patients with type 2 diabetes mellitus in a real‐world clinical setting irrespective of the numbers of oral antidiabetic drugs and insulin use.