Eur J Intern Med. 2026 Oct 3:107219. doi: 10.1016/j.ejim.2026.107219. Online ahead of print.
ABSTRACT
BACKGROUND/AIMS: We evaluated whether statins in non-cirrhotic patients with primary biliary cholangitis (PBC) might influence disease progression, including cirrhosis development, hepatic decompensation, all-cause mortality, liver-related death (LRD) and non-liver-related death (NLRD), as such data are missing.
MATERIALS AND METHODS: We retrospectively analyzed prospectively collected data in 507 non-cirrhotic PBC patients (445 females, age: 53 (16) years, follow-up: 85 (130) months) including 232 that received statins due to increased cardiovascular risk and 275 that had no treatment with statins during the follow-up.
RESULTS: There were no significant differences between the two groups in baseline demographic, clinical and laboratory characteristics except for higher cholesterol, LDL and triglyceride levels and higher frequency of MASLD/MASH in statin users. No differences in treatment response to UDCA (GLOBE score, Paris II) were noted between the groups. Statin users had lower rate of cirrhosis development (3.4% vs. 8%; p=0.03), hepatic decompensation (0.4% vs 4.7%; p=0.003), lower all-cause mortality (3.9% vs. 16.4%; p<0.001), LRD (0.4% vs. 5.1%; p=0.002) and NLRD (3.4% vs. 11.3%; p,0.001) compared to no-statin users. A time-dependent Cox regression analysis revealed significantly higher cirrhosis-free survival (HR=0.139; 95%CI 0.041-0.467, p=0.001) and significantly lower risk of all-cause mortality (HR=0.318; 95%CI 0.153-0.661, p=0.002) and LRDs (HR=0.076; 95%CI 0.010-0.584, p=0.013), while no significant difference was found regarding NLRDs (HR=0.499; 95%CI 0.224-1.111, p=0.089) in statin users compared to non-users.
CONCLUSIONS: Statins seem to independently associate with higher cirrhosis-free survival and lower overall and liver-related mortality in non-cirrhotic patients with PBC. Larger prospective studies are needed to confirm our novel data.
PMID:42829287 | DOI:10.1016/j.ejim.2026.107219