Safety and efficacy of tofogliflozin in Japanese patients with type 2 diabetes mellitus in real-world clinical practice - Results of 3-month interim analysis of a long-term post-marketing surveillance study (J-STEP/LT).

AIMS/INTRODUCTION: This study analysis was conducted to evaluate the safety and efficacy of tofogliflozin, a sodium-glucose co-transporter (SGLT) 2 inhibitor in Japanese patients with type 2 diabetes mellitus (T2DM) in real-world clinical practice.

MATERIALS AND METHODS: This was a 3-year non-interventional observational study in patients with T2DM newly administered tofogliflozin uncontrolled on current therapy. We conducted a 12-week interim analysis of tofogliflozin as a part of 3-year post-marketing surveillance study. The incidence of adverse drug reactions (ADRs) was evaluated as a safety endpoint. As efficacy endpoints, glycated hemoglobin (HbA1c) and body weight were evaluated.

RESULTS: A total of 6897 patients were enrolled. Tofogliflozin significantly reduced mean changes from baseline HbA1c (-0.63%, p<0.0001) and body weight (-2.02 kg, p<0.0001). The change in HbA1c and body weight reductions in response to tofogliflozin were consistently observed in all body mass index subgroups. Any ADRs occurred in 345/6712 patients (5.14%). There was a low incidence of ADRs known to be associated with SGLT2 inhibitors, and they were reported as non-serious. The incidences of polyuria/pollakiuria were higher in patients with ≥ 65 than < 65 years of age and were significantly different among estimated glomerular filtration rate subgroups. Urinary tract and genital infections occurred more frequently in female than in male patients.

CONCLUSIONS: Tofogliflozin was well tolerated, and no emerging new safety concerns were observed. Tofogliflozin significantly improved glycaemic control with no impact on body weight gain. The short-term administration of tofogliflozin is considered to have a favorable benefit-risk profile in Japanese patients with T2DM. This article is protected by copyright. All rights reserved.