Liver disease accounts for two million deaths annually. This is 4% of all deaths (1 out of every 25 deaths worldwide), as per the from 2023. Liver disease is a growing global health concern. A new study suggests that a widely used diabetes medication may offer hope for patients suffering from progressive liver disease.
A recent clinical trial conducted in China and published in suggests that the type 2 diabetes drug dapagliflozin can help patients with severe liver conditions such as metabolic dysfunction-associated steatohepatitis (MASH) and liver fibrosis, which have limited treatment options.
What does the diabetes drug do
Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor, which is widely used to treat type 2 diabetes, has been shown to improve progressive liver disease.
The Chinese researchers found that the drug improved metabolic dysfunction-associated steatohepatitis (MASH), a condition where excess fat accumulates in the liver, leading to inflammation and liver fibrosis (a buildup of scar tissue).
MASH affects more than 5% of adults, and it is also common (30%) in people with diabetes or obesity. This can progress to cirrhosis in up to 25% of individuals. Though previous studies have suggested that SGLT-2 inhibitors can improve liver fat content, liver enzymes, and liver stiffness, no trial has been carried out in patients with MASH.
The study
To understand the effects of dapagliflozin in patients with MASH, the researchers conducted a study. The 48-week study had 154 participants, who were diagnosed with MASH following liver biopsies at six Chinese medical centers from November 2018 to March 2023.
Participants had an average age of 35, and 85% were men. Nearly half (45%0 had type 2 diabetes, and most had evidence of liver fibrosis at various stages (33% stage 1, 45% stage 2, 19% stage 3).
Following an initial screening biopsy, the participants were randomly assigned to receive 10 mg of dapagliflozin or a matching placebo once daily for 48 weeks. They attended health education sessions twice a year. The researchers also recorded body weight, blood pressure, blood glucose, liver enzymes, physical activity, diet, insulin, and lipids of the participants throughout the trial.
MASH improvement was defined as a decrease of at least 2 points in non-alcoholic fatty liver disease activity score (NAS) or a NAS of 3 points or less. By the end of the study, which is after 48 weeks, the researchers observed that 53% (41 of 78) participants in the dapagliflozin group showed improvement in MASH without worsening of fibrosis (defined as no increase in fibrosis stage) compared with 30% (23 of 76) in the placebo group.
23% (18 of 78) participants in the dapagliflozin group showed resolution of MASH without worsening of fibrosis, compared with 8% (6 of 76) in the placebo group.
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They also saw improvement in fibrosis without worsening of MASH in 45% (35 of 78) participants in the dapagliflozin group compared with 20% (15 of 76) in the placebo group.
1% (1 of 78) in the dapagliflozin group and 3% (2 of 76) in the placebo group discontinued the treatment because of adverse events.
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