Trial reportContemporary clinical trials2021
SACRED: Effect of simvastatin on hepatic decompensation and death in subjects with high-risk compensated cirrhosis: Statins and Cirrhosis: Reducing Events of Decompensation.
Trial report in Contemporary clinical trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03654053 (Effect of Simvastatin on Hepatic Decompensation and Death in Subjects With High-risk Compensated Cirrhosis), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effect of Simvastatin on Hepatic Decompensation and Death in Subjects With High-risk Compensated Cirrhosis
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.
- Novel Anti-inflammatory Treatments in Cirrhosis. A Literature-Based Study.Frontiers in medicine · 2021Pooled it
- Atorvastatin reduces recurrent decompensation events in advanced cirrhosis in a randomized placebo-controlled trial.Scientific reports · 2026Trial
- Efficacy of simvastatin as adjunctive therapy in liver cirrhosis: an updated meta-analysis of randomized controlled trials.Annals of medicine and surgery (2012) · 2026Article
- Primary prevention in liver cirrhosis patients with esophageal varicesa: a systematic review and network meta-analysis.Frontiers in gastroenterology (Lausanne, Switzerland) · 2026Review
- Beyond cardiovascular protection: a conceptual and translational review of the hepato-specific mechanisms of statins in metabolic dysfunction-associated steatotic liver disease (MASLD).Frontiers in pharmacology · 2026Review
- Chemoprevention of hepatocellular carcinoma.Hepatology communications · 2025Review
- Drug-Induced Liver Injury in Patients With Chronic Liver Disease.Liver international : official journal of the International Association for the Study of the Liver · 2025Review
- From Pathophysiology to Practice: Evolving Pharmacological Therapies, Clinical Complications, and Pharmacogenetic Considerations in Portal Hypertension.Metabolites · 2025Review
- Endothelial Dysfunction and Liver Cirrhosis: Unraveling of a Complex Relationship.International journal of molecular sciences · 2024Review
- Cardiovascular disease in patients with metabolic dysfunction-associated steatohepatitis compared with metabolic dysfunction-associated steatotic liver disease and other liver diseases: A systematic review.American heart journal plus : cardiology research and practice · 2024Review
- Statins-From Fungi to Pharmacy.International journal of molecular sciences · 2023Review
- Statins in Cirrhosis: Trial Data Are in but the Jury Is Still Out.Digestive diseases and sciences · 2023Article
- Evolution of care in cirrhosis: Preventing hepatic decompensation through pharmacotherapy.World journal of gastroenterology · 2023Review
- Simvastatin ameliorates oxidative stress levels in HepG2 cells and hyperlipidemic rats.Current research in pharmacology and drug discovery · 2022Article
- Statins in Cirrhosis: Hope or Hype?Journal of clinical and experimental hepatologyReview
- Statin Exposure is Associated with Reduced Development of Acute-on-chronic Liver Failure in a Veterans Affairs Cohort.Journal of clinical and experimental hepatologyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 12 institutions in 1 country.
Funding
Abstract
BACKGROUND/
aimsThe development of decompensation in cirrhosis demarcates a marked change in the natural history of chronic liver disease. HMG-CoA reductase inhibitors (statins) exert pleiotropic effects that reduce inflammation and fibrosis as well as improve vascular reactivity. Retrospective studies uniformly have associated statin utilization with improved outcomes for patients with cirrhosis. Prospective human studies have shown that statins reduce portal hypertension and reduce death in patients with decompensated cirrhosis after variceal hemorrhage when added to standard therapy with an acceptable safety profile. This proposal aims to extend these findings to demonstrate that simvastatin reduces incident hepatic decompensation events among cirrhotic patients at high risk for hepatic decompensation.
methodsWe will perform the SACRED Trial (NCT03654053), a phase III, prospective, multi-center, double-blind, randomized clinical trial at 11 VA Medical Centers. Patients with compensated cirrhosis with clinically significant portal hypertension will be stratified based upon the concomitant use of nonselective beta-blockers and randomized to simvastatin 40 mg/day versus placebo for up to 24 months. Patients will be observed for the development of hepatic decompensation (variceal hemorrhage, ascites, encephalopathy), hepatocellular carcinoma, liver-related death, death from any cause, and/or complications of statin therapy. Ancillary studies will evaluate patient-reported outcomes and pharmacogenetic corollaries of safety and/or efficacy.
conclusionStatins have a long track-record of safety and tolerability. This class of medications is generic and inexpensive, and thus, if the hypothesis is proven, there will be few barriers to widespread acceptance of the role of statins to prevent decompensation in patients with compensated cirrhosis. ClinicalTrials.gov Identifier: NCT03654053.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.