Safety and efficacy of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice: interim results of the STELLA-LONG TERM post-marketing surveillance study

Abstract

Ipragliflozin was well tolerated and effective in Japanese patients with T2D; no new safety issues were identified.

Impact of body mass index on the efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes mellitus: A subgroup analysis of 3‐month interim results from the Specified Drug Use Results Survey of Ipragliflozin Treatment in Type 2 Diabetic Patients: Long‐term Use study

“…This subgroup analysis of data from the STELLA‐LONG TERM study was carried out to evaluate the impact of BMI on the efficacy and safety of ipragliflozin in Japanese type 2 diabetes mellitus patients under real‐world conditions. The results pertaining to patient background characteristics showed that patients with higher BMI had less favorable glycemic control and lipid profile, as well as higher blood pressure, estimated glomerular filtration rate, hematocrit and uric acid, than patients with lower BMI, although the clinical significance of differences in the latter three factors remains unclear.…”

“…A detailed description of the STELLA‐LONG TERM study is available in the previous interim report. In summary, the study population comprised all Japanese type 2 diabetes mellitus patients who were first prescribed ipragliflozin between 17 July 2014 and 16 October 2015 at any of the participating medical centers in Japan.…”

“…The study was carried out in accordance with national guidelines for Good Post‐marketing Study Practice. A full description of the study design is provided in the previous report. The report also includes details of the data collected, including demographic and clinical characteristics, information on the use of other medications, laboratory test results, vital signs (i.e., blood pressure and heart rate) and safety data (i.e., adverse events).…”

“…The baseline characteristics of the patients have been reported previously; notably, the proportion of overweight or obese patients registered for the study is unexpectedly large compared with the general Japanese population. Here, we describe a subgroup analysis of the 3‐month interim results from STELLA‐LONG TERM, in which patients were stratified by BMI to investigate the impact of obesity on the efficacy and safety of ipragliflozin.…”

A phase 3 randomized placebo-controlled trial to assess the efficacy and safety of ipragliflozin as an add-on therapy to metformin in Russian patients with inadequately controlled type 2 diabetes mellitus

“…Its beneficial effects on glycemic control and body weight have been demonstrated in a number of randomized, double-blind, placebo-controlled trials [8][9][10][11][12][13][14][15][16]. Since then, a post-marketing long-term study of ipragliflozin has further demonstrated its efficacy and safety in patients with T2DM [17]. While the efficacy and safety of ipragliflozin have been demonstrated in previous phase 3 trials, the majority of these trials were conducted in Asia.…”