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Posted by on Feb 28, 2019 in Diabetes mellitus | 0 comments

In a nutshell

The aim of this study was to investigate the safety and effectiveness of ipragliflozin (Suglat) in the treatment of type 2 diabetes (T2D). The main finding of the study was that ipragliflozin was safe effective in the treatment of T2D and improved liver function.

Some background

Ipragliflozin is a blood sugar lowering drug used in the treatment of T2D. It is an SGLT2 inhibitor. It works by blocking the uptake of sugar in the kidney back into the blood. Instead, the sugar gets removed from the body in the urine.

Often patients with T2D also have non-alcoholic fatty liver disease (NAFLD). This causes liver enzymes (AST and ALT) to increase. Some studies have suggested an improvement in liver function with SGLT2 inhibitors.

The safety and effectiveness of ipragliflozin in real-world clinical practice is unknown, as are the effects of ipragliflozin on liver function.

Methods & findings

The safety of ipragliflozin was analyzed in 11,051 patients with T2D who were treated with the drug. The effectiveness of ipragliflozin was analyzed in 8788 patients with T2D who were treated with the drug. Some of these patients had normal liver function and some had an abnormal liver function. Patients were followed for 12 months.

After 12 months, the rate of overall drug reactions was 14.6%. Serious drug reactions were reported in 0.97% of patients. There was a significant reduction in HbA1c (blood test measuring average blood sugar over the last 3 months) and in fasting blood sugar levels. A reduction of 2.9kg body weight was also seen in patients treated with ipragliflozin. In patients with normal liver function, no changes were seen in liver enzyme levels. However, in patients with abnormal liver function, there were significant decreases in liver enzymes.

The bottom line

The authors concluded that ipragliflozin was effective and safe in patients with T2D over 12 months. Improvements in liver function were also observed in patients with abnormal liver function.

The fine print

This study was funded by Astellas Pharma, the developer of ipragliflozin. There was also no comparison of ipragliflozin to another anti-diabetic drug in this study.

Published By :

Advances in therapy

Date :

Feb 14, 2019

Original Title :

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

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