Simvastatin addition to standard of care improves long-term survival in patients with cirrhosis after variceal bleed: An open label randomized controlled trial.

Authors

Randeep Rana, Mohammed Tabish, Samagra Agarwal, Rajkumar Bayye, Syed Ahmed, Deepak Gunjan, Sanchit Sharma, Anoop Saraya

Published in

The American journal of gastroenterology. Jul 31, 2025. Epub Jul 31, 2025.

Abstract

There is limited evidence about efficacy and safety of simvastatin in decompensated cirrhosis. We assessed whether addition of simvastatin to standard-of-care improves long-term survival in patients with cirrhosis after variceal bleeding.
This was a single-centre open-label randomised controlled trial with superiority design. Patients with cirrhosis (Child-Pugh score 5-12) were randomly assigned to receive either simvastatin[20mg once-daily](n=130) or no drug(n=138) in addition to standard therapy (carvedilol and band ligation) at day-5 of variceal bleeding episode. Primary outcome was all-cause mortality over 24-month follow-up. Secondary outcomes included individual complications of cirrhosis with death before decompensation as a competing event.
Baseline characteristics were similar in both groups with a mean age of 45.0±11.5 years and alcohol(48%) being the predominant aetiology. Most patients were of Child-Pugh A(34%) and B(50%) stage. Twenty-four patients(18%) on simvastatin and 44(31%) on standard therapy died over follow-up[hazard-ratio(HR) for simvastatin: 0.48[95%CI:0.29-0.81;p=0.006) with similar results on intention to treat and on per-protocol analysis(excluding 17 patients who stopped simvastatin). Incidence of ascites(sub-distributional HR):0.60[0.39-0.92] and spontaneous bacterial peritonitis (sHR:0.30[0.11-0.81] was lower in simvastatin arm. All cause decompensation(sHR:0.74[0.52-1.05]), rebleeding(sHR:0.87[0.57-1.34]), hepatic encephalopathy(sHR:0.71[0.42-1.19) and acute-on-chronic liver-failure (sHR:0.65[0.39-1.10]) were comparable in both arms. No heterogeneity of treatment-effect was demonstrated across CTP-class(p=0.105) or aetiology(p=0.39). Incidence of serious adverse events was similar[43% in simvastatin and 52% in standard therapy, absolute risk difference:[9.1%(-2.9 - 21.0%)].
Simvastatin may be associated with improved survival in selected patients with cirrhosis after variceal bleed and reduced incidence of new onset/refractory ascites and its complications [CTRI/2022/07/044263].

PMID:
40736696
Bibliographic data and abstract were imported from PubMed on 30 Jul 2025.

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