The sodium glucose cotransporter 2 (SGLT-2) inhibitor drug dapagliflozin, broadly used to deal with kind 2 diabetes, additionally exhibits enhancements for sufferers with progressive liver illness, finds a scientific trial from China revealed by The BMJ.
The outcomes present that therapy with dapagliflozin improved metabolic dysfunction-associated steatohepatitis (MASH)—a situation the place extra fats accumulates within the liver, resulting in irritation—and liver fibrosis (a construct up of scar tissue) in contrast with placebo.
MASH impacts greater than 5% of adults, greater than 30% of people with diabetes or weight problems, and might progress to cirrhosis in as much as 25% of people.
A number of research have reported that SGLT-2 inhibitors can enhance liver fats content material, liver enzymes, and liver stiffness, however no trial has been carried out amongst sufferers with MASH.
To handle this, researchers enrolled 154 adults (common age 35; 85% males) identified with MASH after a liver biopsy at six medical facilities in China from November 2018 to March 2023.
Nearly half (45%) had kind 2 diabetes, and virtually all had liver fibrosis (33% stage 1, 45% stage 2, 19% stage 3).
After an preliminary screening biopsy, individuals have been randomly assigned to obtain 10 mg of dapagliflozin or matching placebo as soon as day by day for 48 weeks and attended well being schooling periods twice a yr.
Varied components together with physique weight, blood strain, blood glucose, liver enzymes, bodily exercise, eating regimen, insulin, and lipids have been additionally assessed at enrollment and all through the trial.
MASH enchancment was outlined as a lower of a minimum of 2 factors in non-alcoholic fatty liver illness exercise rating (NAS) or a NAS of three factors or much less.
After an finish of examine biopsy at week 48, 53% (41 of 78) individuals within the dapagliflozin group confirmed enchancment in MASH with out worsening of fibrosis (outlined as no enhance in fibrosis stage) in contrast with 30% (23 of 76) within the placebo group.
Decision of MASH with out worsening of fibrosis occurred in 23% (18 of 78) individuals within the dapagliflozin group in contrast with 8% (6 of 76) within the placebo group.
Fibrosis enchancment with out worsening of MASH was additionally reported in 45% (35 of 78) individuals within the dapagliflozin group in contrast with 20% (15 of 76) within the placebo group.
The proportion of individuals who discontinued therapy due to opposed occasions was 1% (1 of 78) within the dapagliflozin group and three% (2 of 76) within the placebo group.
The researchers acknowledge that the trial was carried out in a Chinese language inhabitants, which limits its broader generalizability, and that feminine and older sufferers have been under-represented. However they level out that outcomes have been constant after additional analyses, suggesting they’re strong.
As such, they conclude, “Our findings point out that dapagliflozin could have an effect on key elements of MASH by bettering each steatohepatitis and fibrosis.” Giant-scale and long-term trials are wanted to additional verify these results, they add.
The approaching years are anticipated to be notably thrilling within the discipline of pharmacological therapy for MASH, say researchers from Argentina in a linked editorial.
As extra medicine grow to be out there, therapeutic selections will doubtless grow to be more and more tailor-made to particular person affected person profiles, they write. “Ideally, such remedies ought to present cardiovascular profit, have a longtime security profile, and be accessible to broad and various affected person populations,” they conclude.
Extra info:
Impact of dapagliflozin on metabolic dysfunction-associated steatohepatitis: multicentre, double blind, randomised, placebo managed trial, The BMJ (2025). DOI: 10.1136/bmj-2024-083735
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Diabetes drug exhibits advantages for sufferers with liver illness (2025, June 4)
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