Safety and Effectiveness of Ipragliflozin for Type 2 Diabetes in Japan: 12-Month Interim Results of the STELLA-LONG TERM Post-Marketing Surveillance Study

Abstract

IntroductionThe present interim report of the STELLA-LONG TERM study aimed to examine the safety and effectiveness of ipragliflozin in real-word clinical practice in Japan using data up to 12 months. We also evaluated the effect of ipragliflozin on aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels in patients with normal vs. abnormal liver function.MethodsThis is an ongoing 3-year post-marketing surveillance study. We analyzed data from Japanese type 2 diabetes mellitus (T2DM) patients who were first prescribed ipragliflozin between 17 July 2014 and 16 October 2015 at participating centers in Japan, and whose data were locked by 16 January 2018. The incidence of adverse drug reactions (ADRs) was evaluated for safety. Changes in glycemic control and body weight were evaluated for effectiveness. The effect on liver function was evaluated by changes in the fatty liver index, and changes in AST and ALT were evaluated in patients with normal and abnormal liver function.ResultsThe safety analysis set comprised 11,051 patients and the efficacy analysis set comprised 8788 patients. The incidence rates of ADRs and serious ADRs were 14.6% (1616/11,051) and 0.97% (107/11,051), respectively. Significant reductions (all P < 0.001 vs. baseline, paired t test) in glycated hemoglobin (− 0.8%), fasting plasma glucose (− 31.9 mg/dL), body weight (− 2.9 kg), and fatty liver index (− 8.7) were observed. In patients with normal liver function at baseline, no clinically significant changes in AST and ALT were observed. In patients with abnormal liver function at baseline, clinically and statistically significant decreases (P < 0.05 vs. baseline, two-sample t test) in AST (− 9.0 U/L) and ALT (− 14.7 U/L) levels were observed.ConclusionIpragliflozin was effective and well tolerated in Japanese patients with T2DM over 12 months in the real-world clinical setting. Improvements in liver function parameters (AST and ALT) were observed in T2DM patients with abnormal liver function.Trial RegistrationClinicalTrials.gov identifier, NCT02479399.FundingAstellas Pharma Inc., Japan.

Long‐term (52‐week) efficacy and safety of ipragliflozin add‐on therapy to insulin in Japanese patients with type 1 diabetes mellitus: An uncontrolled, open‐label extension of a phase III study

“…The safety and efficacy of ipragliflozin in type 2 diabetes patients has been shown through clinical trials and post‐marketing surveys. Several studies have shown that ipragliflozin lowers blood glucose levels in an insulin‐independent fashion, and hence is expected to be efficacious in type 1 diabetes, as well as type 2 diabetes.…”

Safety and effectiveness of empagliflozin in Japanese patients with type 2 diabetes: interim analysis from a post-marketing surveillance study

“…Since the approval of the first SGLT2 inhibitor in Japan in 2014, the class has become widely used. In several post-marketing surveillance (PMS) studies, including in elderly patients, adverse drug reactions (ADRs) occurred at similar or lower frequencies to clinical trials, with no new safety concerns [2][3][4][5].…”

Safety and effectiveness of ipragliflozin in elderly versus non-elderly Japanese type 2 diabetes mellitus patients: 12 month interim results of the STELLA-LONG TERM study

“…The STELLA-LONG TERM study is an ongoing post-marketing surveillance study examining the safety and effectiveness of ipragliflozin in real-world clinical practice in Japan. Several analyses based on interim cutoff data and various subgroup analyses have been conducted so far [12][13][14][15][16] . One of the published subgroup analyses evaluated the safety and effectiveness of ipragliflozin in non-elderly vs elderly patients (<65 vs !65 years) using data from 3, 12 and 24 months.…”