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November 21, 2023
2 min read
- Treatment with aspirin resulted in a 6-month 10.3% mean absolute reduction and a 59.2% relative reduction in liver fat content via MRS-PDFF.
- Aspirin also improved indices of liver inflammation and fibrosis.
BOSTON — Low-dose aspirin significantly reduced steatosis in patients with metabolic dysfunction-associated steatotic liver disease and improved markers of liver inflammation and fibrosis, according to data presented at The Liver Meeting.
“Even though there are some promising therapeutics in development for MASLD, there is still no FDA-approved agent,” Robert M. Wilechansky, MD, a transplant hepatology fellow at Massachusetts General Hospital, told Healio. “We hoped to investigate the potential benefit of aspirin as a low-cost, existing therapy for MASLD based on prior preclinical and observational data supporting the possibility.”
Wilechansky and colleagues conducted a 6-month, randomized, double-blind trial and randomly assigned 80 adults with MASLD and no cirrhosis to daily aspirin 81 mg (n = 40) or placebo (n = 40) for 6 months. Of these, 71 patients completed the trial — 37 in the aspirin group and 34 in the placebo group.
The study’s primary endpoint was change from baseline in hepatic fat fraction (HFF) via magnetic resonance spectroscopy, Wilechansky said. Other endpoints included change from baseline in MRI-proton density fat fraction (MRI-PDFF), iron-corrected T1 (cT1) score, liver stiffness, alanine aminotransferase, aspartate aminotransferase and BMI.
Researchers assessed treatment effects based on results from the intention-to-treat population.
According to Wilechansky, there was a 6% absolute decrease in HFF in the aspirin group compared with 4.2% in the placebo group in the intention-to-treat population, with similar results reported in the per-protocol population. The net absolute treatment effect was a 10.3% decrease in HFF compared with placebo.
“Relative to the key secondary endpoint, the aspirin group showed a relative decrease from baseline MRI-HFF, and this was a significant difference to the placebo group, which actually had a relative increase in hepatic fat fraction,” Wilechansky told attendees. “Results were consistent in the intention-to-treat and per-protocol analyses.”
Further, aspirin produced a 59.2% reduction in liver fat compared with placebo, and 40% of those who received aspirin achieved a relative reduction in HFF of at least 30% compared with 12.5% of those on placebo. Participants in the aspirin group also had a significantly greater reduction in hepatic fat measured by MRI-PDFF compared with placebo.
“Aspirin also improved indices of liver inflammation and fibrosis, including ALT, AST, the MRI-based cT1 score and liver stiffness by transient elastography,” Wilechansky told Healio.
“The treatment was safe and well-tolerated over the course of the trial,” he added, noting that heartburn was the only drug-related adverse event in the aspirin group, and only one participant in each group discontinued treatment because of an adverse event.
“We will need larger clinical trials to test the efficacy of aspirin in reversing biopsy-proven steatohepatitis, preventing fibrosis and preventing other adverse clinical outcomes in MASLD,” Wilechansky told Healio. “Overall, aspirin represents a potential therapeutic option for MASLD that is economical, safe and well-tolerated.”
Wilechansky RM, et al. Daily aspirin therapy for the treatment of metabolic dysfunction-associated steatotic liver disease: A randomized controlled trial. Presented at: The Liver Meeting; Nov. 10-14, 2023; Boston (hybrid meeting).
Wilechansky reports no relevant financial disclosures.