Dapagliflozin results in more patients with improved or resolved MASH without worsening of fibrosis, improved fibrosis without worsening of MASH
By Elana Gotkine HealthDay Reporter
FRIDAY, June 6, 2025 (HealthDay News) — For patients with metabolic dysfunction-associated steatohepatitis (MASH), treatment with dapagliflozin is beneficial for improvement of MASH without worsening of fibrosis and for improvement of fibrosis without worsening of MASH, according to a study published online June 4 in The BMJ.
Jiayang Lin, from the Nanfang Hospital of Southern Medical University in Guangzhou, China, and colleagues examined the efficacy and safety of the sodium-glucose cotransporter 2 inhibitor dapagliflozin in participants with MASH in a multicenter, double-blind, randomized trial conducted in six tertiary hospitals in China. One hundred fifty-four adults with biopsy-diagnosed MASH were randomly assigned to receive 10 mg orally of dapagliflozin or matching placebo once daily for a 48-week period. MASH improvement (defined as a decrease of ≥2 points in nonalcoholic fatty liver disease activity score [NAS] or a NAS of ≤3 points) without worsening of fibrosis was the primary end point.
The researchers found that 53 percent of the 78 participants in the dapagliflozin group and 30 percent of the 76 participants in the placebo group had MASH improvement without worsening of fibrosis (risk ratio, 1.73), with a mean difference in NAS of −1.39. MASH resolution without worsening of fibrosis occurred in 23 and 8 percent of participants in the dapagliflozin and placebo groups, respectively (risk ratio, 2.91). Fibrosis improvement without worsening of MASH was reported in 45 and 20 percent of participants in the dapagliflozin and placebo groups, respectively (risk ratio, 2.25). Overall, 1 and 3 percent of patients in the dapagliflozin and placebo groups, respectively, discontinued treatment because of adverse events.
“These results support the potential for dapagliflozin to provide benefit to patients with MASH and liver fibrosis,” the authors write.
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