medwireNews: Results of a randomized trial suggest that the sodium-glucose cotransporter 2 (SGLT2) inhibitor ipragliflozin has equivalent efficacy to pioglitazone for the treatment of patients with type 2 diabetes complicated by nonalcoholic fatty liver disease (NAFLD).
“Because disorders encompassing NAFLD/[nonalcoholic steatohepatitis] are extremely closely related to macrovascular events and hepatocarcinogenesis, which reduce life expectancy in patients with diabetes, it is extremely important to perform early and appropriate therapeutic interventions for type 2 diabetes complicated by NAFLD,” write the study authors in Diabetes Care.
However, “there is presently no established form of treatment” for patients with both conditions, they note.
In their open-label trial, Daisuke Ito (Saitama Medical University, Japan) and fellow researchers found that the mean liver-to-spleen attenuation (L/S) ratio increased by 0.22, from a baseline measurement of 0.80 among the 30 patients randomly assigned to receive treatment with ipragliflozin 50 mg once daily for 24 weeks. By comparison, the L/S ratio increased by 0.21 from a baseline of 0.78 among the 31 participants receiving pioglitazone 15–30 mg once daily, a nonsignificant difference.
Aspartate aminotransferase, glycated hemoglobin (HbA1c), and fasting plasma glucose levels also improved to a similar degree from baseline to week 24 in the ipragliflozin and pioglitazone groups, with corresponding reductions of 12.6 versus 11.6 U, 0.94 versus 1.11%, and 23.6 versus 26.1 mg/dL.
Together, these findings suggest that the two drugs exert “equally beneficial effects on NAFLD and glycemic control,” say the study authors.
However, participants receiving ipragliflozin experienced a significant 2.3 kg reduction in body weight over the study period, from a mean 79.6 kg at baseline to 77.3 kg at week 24, whereas those in the pioglitazone gained a mean 0.9 kg from a baseline of 76.7 kg.
And visceral fat area decreased significantly, by 26.1 cm2, among participants in the ipragliflozin group, compared with a slight decrease of 2.6 cm2 for those in the pioglitazone group, suggesting that “these two drugs have different NAFLD-improving mechanisms.”
It is possible that ipragliflozin “corrects insulin resistance and the associated hyperinsulinemia, thereby improving NAFLD,” whereas “pioglitazone exerts beneficial effects on NAFLD by qualitatively improving adipose tissue,” speculate the researchers.
Ito and colleagues caution that their study was limited by its small sample size and open-label design, and note that “histological evaluation, which is the gold standard for measuring liver steatosis, was not performed.”
Looking to the future, they call for “a long-term, large-scale investigation including histological evaluations.”
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