Effect of ipragliflozin on liver function in Japanese type 2 diabetes mellitus patients: a subgroup analysis of the STELLA-LONG TERM study (3-month interim results)

Abstract

This subgroup analysis of STELLA-LONG TERM, an ongoing 3-year post-marketing surveillance study on the long-term efficacy and safety of ipragliflozin, assessed the effect of ipragliflozin on liver function in type 2 diabetes mellitus (T2DM) patients. Patients were divided according to baseline liver function (normal [male: ALT ≤30, female: ALT ≤20], abnormal [male: ALT ≥31, female: ALT ≥21]). We evaluated changes in aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (γ-GTP), alkaline phosphatase (ALP), and fatty liver index (FLI) at 3 months of treatment; the proportion of patients with abnormal liver function whose liver function normalized after 3 months of treatment; and correlations between changes in ALT levels and efficacy variables/laboratory values. Liver function was normal in 2,570 and abnormal in 3,239 patients. Only patients with abnormal liver function showed a statistically/clinically significant decrease in AST, ALT, γ-GTP, and ALP levels at 3 months (all p < 0.05 vs. baseline). The FLI significantly decreased from 63.2677 ± 26.4363 (baseline) to 56.7137 ± 27.6484 (3 months) (p < 0.05) in the overall patient population. Liver function normalized in 20.5% (543/2,648) of patients with abnormal liver function. There was no obvious correlation between changes in ALT and changes in efficacy/laboratory parameters. Liver function improved after 3-month treatment with ipragliflozin in T2DM patients with abnormal liver function.

Real-World Evidence for Long-Term Safety and Effectiveness of Ipragliflozin in Japanese Patients with Type 2 Diabetes Mellitus: final Results of a 3-Year Post-Marketing Surveillance Study (STELLA-LONG TERM)

“…A long-term postmarketing surveillance study (STELLA-LONG TERM [Specified drug use resulTs survEy of ipragLifLozin treAtment in type 2 diabetic patients: LONG-TERM use]), was conducted over a period of 3 years in routine clinical practice and registered more than 11,000 patients. Reports based on interim data covering periods of up to 3 months, 12 months, and 2 years after treatment initiation, including subgroup analyses based on age, body mass index (BMI), and hepatic/renal function, have been published previously [21,22,26]. These previous analyses based on interim data have demonstrated that ipragliflozin is well tolerated, including in the elderly and other age subgroups, and maintains glycemic control and body weight reduction for up to 24 months after treatment initiation.…”

Association between Fatty Liver Index and Periodontitis: the Korea National Health and Nutrition Examination Survey

“…Indeed, it is proposed that mean FLI was lower and FLI was less accurate www.nature.com/scientificreports www.nature.com/scientificreports/ in NAFLD prediction in Asian studies 31 . However, in recent large-scale Asian population studies in Chinese, Japanese, and Asian-Americans in the U.S., respectively, FLI was recognized and used as a relatively predictable noninvasive diagnostic tool to study of NAFLD also in Asian populations [32][33][34] . Regardless of ethnicity, this is the first study to show the association of periodontitis prevalence with FLI to the best of our knowledge.…”

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.…”