TOPLINE:

Statin use in patients with primary biliary cholangitis (PBC) was associated with reduced risks for hepatic decompensation and major adverse liver outcomes.

METHODOLOGY:

• Previous studies have shown that statins reduce fibrosis progression in various chronic liver diseases, but their effect in PBC remains uncertain.
• Researchers emulated a target trial using data from the Mass General Brigham network in the US and the Asan Medical Center in Seoul, South Korea, to assess the effect of statin use on the risk for incident hepatic decompensation in patients with PBC.
• Adult patients who fulfilled at least two of the three criteria for PBC were included: elevated levels of alkaline phosphatase, presence of antimitochondrial antibodies or PBC-specific antinuclear antibodies, or histologic features.
• A total of 282 monthly trials were constructed from January 2001 to June 2024, and seven statins were evaluated, with statin use defined as a cumulative defined daily dose of 90 or more days.
• The primary outcome was hepatic decompensation, defined as the occurrence of ascites, variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, or hepatic encephalopathy. The secondary outcome was major adverse liver outcome — a composite of hepatic decompensation, hepatocellular carcinoma, and transplantation.

TAKEAWAY:

• Overall, 443 statin users were propensity score-matched with 886 nonusers who never initiated statin therapy. Over a median follow-up duration of 3.8 years, hepatic decompensation was observed in 5.4% of statin users and 7.6% of nonusers.
• Statin use was associated with a 39% reduction in risk for hepatic decompensation in patients with PBC (hazard ratio [HR], 0.61; 95% CI, 0.38-0.97).
• Ascites was the most common decompensation event, occurring in 45.8% of statin users and 44.8% of nonusers.
• The risk for major adverse liver outcome was reduced by 42% in statin users vs nonusers (HR, 0.58; 95% CI, 0.38-0.89). Most major adverse liver outcomes in both groups were due to hepatic decompensation, with fewer cases of liver cancer and transplantation.

IN PRACTICE:

“These findings suggest a potential role for statins in improving long-term liver-related outcomes in patients with PBC, a population with limited therapeutic options beyond UDCA [ursodeoxycholic acid] and obeticholic acid,” the authors of the study wrote.

SOURCE:

The study was led by Jonggi Choi, MD, PhD, Asan Medical Center, University of Ulsan College of Medicine, Seoul, and Junqing Xu, Massachusetts General Hospital, Harvard Medical School, Boston. It was published online in Hepatology.

LIMITATIONS:

The study could not fully assess or adjust for alcohol use history. Some patients may have had metabolic dysfunction-associated steatotic liver disease, which could introduce confounding. Liver stiffness and controlled attenuation parameter-based steatosis measurements were not available for many patients. The study lacked histologic data and detailed clinical assessments, limiting the ability to stratify risk or assess treatment response heterogeneity.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health. One author disclosed receiving grants from Gilead, and another author reported consulting for RegCell and having an advisory role with Ipsen, Gilead, and Mirum.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.