Statin therapy in patients with cirrhosis

Wright, Andrew; Adusumalli, Srinath; Corey, Kathleen E.

doi:10.1136/flgastro-2014-100500

Cited by 15 publications

(11 citation statements)

References 61 publications

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“…The third was a short-term study in which rosuvastatin was given for 14 days [ 38 ]. An additional review article [ 39 ] contained relevant information on pravastatin pharmacokinetics. Finally, drug product monographs [ 34 , 35 ] for atorvastatin and pitavastatin reported pharmacokinetics information.…”

Section: Resultsmentioning

confidence: 99%

“…In general, all available information showed higher AUC and C max in Child–Pugh class B participants compared to Child–Pugh class A participants. Data in fluvastatin [ 37 ] and pravastatin [ 39 ] did not specify the Child–Pugh classes of participants. We did not find information on pharmacokinetic changes related to lovastatin and simvastatin in cirrhosis.…”

Section: Resultsmentioning

confidence: 99%

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A systematic review on pharmacokinetics, cardiovascular outcomes and safety profiles of statins in cirrhosis

et al. 2021

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Background/Aims There is increased interest in the therapeutic use of statins in cirrhosis, but preferred statin and safety outcomes are still not well known. In this systematic review we aimed to address pharmacokinetics (PK), safety, and effects on cardiovascular (CV) outcomes of statins in cirrhosis. Methods Our systematic search in several electronic databases and repositories of two regulatory bodies up to 2020-06-11 yielded 22 articles and 2 drug monographs with relevant data. Results Rosuvastatin and pitavastatin showed minimal PK changes in Child–Pugh A cirrhosis. Only rosuvastatin was assessed in a repeated dosing PK study. Atorvastatin showed pronounced PK changes in cirrhosis. No PK data was found for simvastatin, the most commonly used statin in cirrhosis trials. There was insufficient data to assess CV effects of statins in cirrhosis. Clinical trials in cirrhosis were limited to simvastatin, atorvastatin, and pravastatin. In patients taking simvastatin 40 mg, pooled frequency of rhabdomyolysis was 2%, an incidence 40-fold higher than that reported in non-cirrhosis patients, while this was no rhabdomyolysis observed in patients on simvastatin 20 mg, atorvastatin 20 mg, or pravastatin 40 mg. Drug-induced liver injury was of difficult interpretation due to co-existence of muscle damage. No overt liver failure was reported. Conclusions Simvastatin 40 mg should be avoided in decompensated cirrhosis. Safety data on simvastatin 20 mg or other statins are based on small study sample size. This rarity of evidence combined with lack of data in dose adjustment methods in cirrhosis is a barrier for using statins for CV indications or for investigational use for liver indications.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

A systematic review on pharmacokinetics, cardiovascular outcomes and safety profiles of statins in cirrhosis

et al. 2021

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“…Statin treatment was generally well tolerated but a few patients developed severe side effects, particularly rhabdomyolysis. Despite these promising beneficial effects, further RCTs are required, with larger patient series and hard clinical endpoints should be performed before statins can be recommended for use in patients with chronic liver disease [14–19]. However, statins itself could lead to hepatic dysfunction [6], especially in combination with the drug which is metabolised by cytochrome P450 enzyme system [20].…”

Section: Introductionmentioning

confidence: 99%

Comprehensive evaluation of effects and safety of statin on the progression of liver cirrhosis: a systematic review and meta-analysis

Yang

Hang

et al. 2019

BMC Gastroenterol

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BackgroundStatin has been more and more widely used in chronic liver disease, however, existed studies have attained contradictory results. According to the present study, we aimed to test the efficacy and safety of statin via a meta-analysis.MethodsDifferent databases were searched for full-text publication based on inclusion and exclusion criteria. For data-pooling, fixed-effect model was applied if heterogeneity wasn’t detected. Otherwise, random-effect model was adopted. Heterogeneity was detected by I squire (I2) test. All results of analysis were illustrated as forest plots. Publication bias was assessed using the Begg’s adjusted rank correlation test. Standard mean difference (SMD) was calculated in continuous variables. Pooled hazard ratio or odds ratio was calculated in catergorical variables.ResultsSeventeen clinical studies were finally included. Hepatic portal hemodynamic parameters were improved in statin users for a short-term response. For a long-term follow-up, statin treatment surprisingly decreased mortality rate (HR = 0.782, 95% CI: 0.718–0.846, I2 > 50%) and lower the occurrence of hepatocellular carcinoma (HR = 0.75, 95% CI: 0.64–0.86, I2 > 50%) in liver cirrhosis. Statin seemed not to decrease the risk of esophageal variceal bleeding and spontaneous bacterial peritonitis. However, statin was proved to decrease the risk of hepatic encephalopathy and ascites. Incidence of drug related adverse events didn’t increase in statin users. Dose-dependent effects of statin on hepatocellular carcinoma development, decompensated cirrhosis events occurrence, and liver cirrhosis progression.ConclusionStatin influenced parameters of hepatic portal vessel pressure in short-term treatment. Prognosis of liver cirrhosis benefited from statin treatment in long term follow-up. The efficacy and safety of statin in liver cirrhosis treatment is confirmed. To date, similar study is hardly seen before.

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“…However, Pollo-Flores et al [18] found no patients who received simvastatin showed an increase in aminotransferases levels, on the contrary, they found that the patients in the simvastatin group had a small improvement in Child-Pugh score. A moderate rise in serum aminotransferase levels has been reported in 1%-3% of cardiovascular patients after using statins [39], the hepatotoxicity of statins in cirrhotic patients does not seem to be higher than that among the cardiovascular patients and should not be a major concern. Observational studies suggested that myalgia could occur in up to 10% of persons prescribed statins, whereas rhabdomyolysis continued to be rare [40].…”

Section: Discussionmentioning

confidence: 97%

Effects of Statins on the Hepatic Decompensation, Mortality, Complications and Drug Safety in Liver Cirrhosis: A Systematic Review and Meta-Analysis

Tantai¹

2018

AJIM

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Background and Aim: Evidence indicates statins seem to improve outcomes in cirrhotic patients. Systematic review and meta-analysis are performed to evaluate the effect and safety of statins in the setting of cirrhosis. Methods: We searched PubMed, EMBASE, and the Cochrane Library from inception through January 2018 to identify comparative studies evaluating the role of statins in cirrhosis. Pooled risk estimates with 95% confidence intervals were calculated using a random effects model. Results: Eight studies (4 retrospective cohort studies and 4 randomized controlled trials) involving 3,966 cirrhotic patients were included. Statin use was associated with 56% lower risk of progression to decompensated cirrhosis (RR, 0.44; 95% CI, 0.36-0.54) and 47% lower risk of mortality (RR, 0.53; 95% CI, 0.47-0.61). Subgroup analyses showed that these results were generally consistent regardless of study design, etiology of cirrhosis, stage of cirrhosis, follow-up time, method of identifying cirrhosis. For initial variceal bleeding, pooled RR was 0.48 (0.35-0.67). For ascites, pooled RR was 0.66 (0.45-0.99). For portal hypertension, using statins could increase the HVPG response rate, pooled RR was 2.61(1.03-6.62). For hepatocellular carcinoma, pooled RR was 0.47(0.36-0.63). For any adverse event and serious adverse events, using statins was almost equivalent to nonusers, pooled RR was 1.06 (0.50-2.25) and 0.77 (0.31-1.95). Conclusions: Statin use may be associated with reduced risk of hepatic decompensation and mortality in cirrhosis with well tolerated. Additionally, statin use appears to decrease portal hypertension and reduce the risk of initial variceal bleeding, ascites and hepatocellular carcinoma. Further RCTs will be required to confirm our findings.

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Statin therapy in patients with cirrhosis

Cited by 15 publications

References 61 publications

A systematic review on pharmacokinetics, cardiovascular outcomes and safety profiles of statins in cirrhosis

A systematic review on pharmacokinetics, cardiovascular outcomes and safety profiles of statins in cirrhosis

Comprehensive evaluation of effects and safety of statin on the progression of liver cirrhosis: a systematic review and meta-analysis

Effects of Statins on the Hepatic Decompensation, Mortality, Complications and Drug Safety in Liver Cirrhosis: A Systematic Review and Meta-Analysis

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