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Role of N-Acetylcysteine in Non-Acetaminophen-Related Acute Liver Failure: an Updated Meta-Analysis and Systematic Review

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Role of N-Acetylcysteine in Non-Acetaminophen-Related Acute Liver Failure: an Updated Meta-Analysis and Systematic Review ORIGINAL ARTICLE Annals of Gastroenterology (2021) 34, 1-6 Role of N-acetylcysteine in non-acetaminophen-related acute liver failure: an updated meta-analysis and systematic review Saqib Walayata, Hasan Shoaibb, Muhammad Asgharb, Minchul Kimb, Sonu Dhillona University of Illinois College of Medicine at Peoria, IL, USA Abstract Background The American Association for the Study of Liver Diseases recommends that N-acetylcysteine (NAC) may be beneficial in non-acetaminophen-related drug-induced liver injury. A subsequent review and analysis reported the current evidence to be inconclusive. Herein, we present an updated review and meta-analysis. Methods We evaluated prospective, retrospective and randomized controlled trials that compared outcomes in patients of all ages with acute liver failure (defined as abnormal liver enzymes along with elevated international normalized ratio >1.5, with or without hepatic encephalopathy) receiving NAC with the outcomes in a control group. The primary outcome was to compare the overall survival in the 2 groups. Secondary outcomes included difference in length of hospital stay, transplant-free survival, and post-transplant survival. Results Seven studies (N=883) that met the inclusion criteria were included in this analysis. The mean age of patients in the NAC group was 21.22 years compared with 23.62 years in the control group. The odds of overall survival were significantly higher in the NAC group than in controls (odds ratio [OR] 1.77, 95% confidence interval [CI] 1.3-2.41). Post-transplant survival (OR 2.44, 95%CI 1.11-5.37) and transplant-free survival were also better in the NAC group than in the control group (OR 2.85, 95%CI 2.11-3.85). Patients in the control group had statistically significant odds of a longer inpatient stay (mean difference 7.79, 95%CI 6.93-8.66). Conclusion In patients with non-acetaminophen-related acute liver failure, NAC significantly improves overall survival, post-transplant survival and transplant-free survival while decreasing the overall length of hospital stay. Keywords N-acetylcysteine, acute liver failure, drug-induced liver injury, acetaminophen Ann Gastroenterol 2021; 34 (1): 1-6 Introduction 30% [1]. The term was originally used by Trey and Davidson in the 1970s. The International Association for the Study of the Acute liver failure is a rare, life-threatening disease Liver further classifies liver failure into hyperacute liver failure, characterized by acute liver dysfunction in patients who have occurring within 10 days of the inciting event, fulminant, no previous history of underlying liver disease. It is a rapidly occurring within 10-30 days, and subacute hepatic failure, progressive disorder with a reported incidence of around occurring within 5-24 weeks [2]. 2000-3000 cases per year in the US, with mortality as high as Acetaminophen remains the most common etiology of acute liver failure in the US, followed by other drug-induced Department of aGastroenterology and Hepatology (Saqib Walayat, liver injury and hepatitis B virus [1]. Medical management Sonu Dhillon); bInternal Medicine (Hasan Shoaib, Muhammad Asghar usually involves supportive measures that depend on the Minchul Kim), University of Illinois College of Medicine at Peoria, underlying etiology. Liver transplant remains the only effective Peoria, IL, USA treatment, but given the limited number of organs available, Conflict of Interest: None other treatment modalities have been sought. N-acetylcysteine (NAC) has been the drug of choice for Correspondence to: Saqib Walayat, MD, Department of the treatment of acetaminophen-related liver failure since the Gastroenterology and Hepatology, 530 NE Glen Oak Ave, Peoria, IL, USA 61637, e-mail: [email protected] 1970s. It is a thiol-containing derivative of amino acid cysteine. NAC helps neutralize free oxygen radicals and replenishes Received 21 May 2020; accepted 4 August 2020; cytoplasmic and mitochondrial glutathione stores by acting as published online 4 January 2021 a glutathione substitute and directly combining with reactive DOI: https://doi.org/10.20524/aog.2021.0571 metabolites. It serves as a source of sulfate, thus enhancing © 2021 Hellenic Society of Gastroenterology www.annalsgastro.gr 2 S. Walayat et al non-toxic sulfate conjugation and preventing hepatic gastroenterology journals for the past 3 years. The search damage [3-5]. It has also been suggested that NAC may have terms used were non-acetaminophen-related acute liver a vasodilatory and inotropic role, thus improving perfusion injury, acute liver failure, N-acetylcysteine, drug-induced liver and oxygenation to vital organs during shock-like states [4,6]. injury, transplant-free survival, overall survival, mortality, While the role of NAC in acetaminophen-induced liver failure morbidity, length of hospital stay, complications, meta- is pivotal, in 2011 the American Association for the Study of analysis, and systematic review. The reference lists of all Liver Diseases (AASLD) guidelines suggested NAC may also eligible studies were reviewed to identify additional studies. be beneficial in non-acetaminophen-related drug-induced The retrieved studies were carefully examined to exclude liver injury [7]. The evidence for this recommendation potential duplicates or overlapping data. Titles and abstracts came largely from a double blinded randomized trial by selected from the initial search were first scanned, and the full Lee et al, which showed that intravenous NAC improved papers of potential eligible studies were reviewed. Two authors transplant-free survival in non-acetaminophen-related acute (SW and HS) independently searched and extracted the data liver failure. The majority of patients in the study had drug- into an abstraction form. Any differences were resolved by induced liver injury (DILI) [8]. Hu et al published a meta- mutual agreement. Preferred Reporting Items for Systematic analysis in 2015, which included 4 prospective studies. Their reviews and Meta-Analysis guidelines (PRISMA) statement results showed an insignificant difference in overall survival guidelines were followed for conducting and reporting meta- between the NAC and control groups. However, the NAC analyses. The PICOS scheme was followed for reporting group was found to have better transplant-free survival and inclusion criteria. post-transplant survival [9]. Chughlay et al, in their meta- analysis in 2016, concluded that the current evidence is inconclusive to determine whether there is a role for NAC in Study selection criteria non-acetaminophen-related DILI [3]. Newer studies have since been published that were not We included prospective and retrospective studies in our included in previous meta-analyses [10-12]. In our meta- meta-analysis. The patient population could range anywhere analysis we sought to include all available studies, including from neonates to adults. NAC could be administered orally randomized control trials and retrospective studies evaluating or intravenously. The following information was extracted the efficacy of NAC in non-acetaminophen-related acute from the study: authors, year of publication, place, study liver injury. The primary outcome was to compare the overall design, number of patients receiving NAC, dose and route survival in patients presenting with acute liver failure who of NAC administration, age, length of stay, overall survival, received NAC vs. those who did not. Secondary outcomes transplant-free survival, post-transplant survival in NAC and included differences in length of hospital stay, transplant-free control group. Articles were excluded if: 1) they were not survival, and post-transplant survival. written in English; 2) no outcomes were reported; or 3) they represented review articles or studies published as abstracts only. Materials and methods Statistical analysis Study selection criteria Microsoft Excel was used for data collection. Statistical We looked at studies assessing the efficacy of NAC in non- analysis was performed using Rev-Man 5.3 (Cochrane acetaminophen-related acute liver failure. Acute liver failure Collaboration, Oxford, UK). We conducted a random-effect was defined as abnormal liver enzymes along with an elevated meta-analysis when there was significant heterogeneity; international normalized ratio >1.5, with or without the otherwise, we used the fixed-effect model. For effect presence of encephalopathy, in a patient who previously had sizes the odds ratio (OR) for dichotomous outcomes and no evidence of liver disease. standardized mean difference (SMD) for continuous variables were calculated using a random-effect model in cases of significant heterogeneity between estimates. Data collection and extraction The heterogeneity among studies was tested using the I2 statistic and Cochrane’s Q test [13]. An I2 value of 0-39% We searched the following databases: MEDLINE, PubMed, was considered as non-significant heterogeneity; 40-75% Ovid journals, Embase, Cumulative Index for Nursing as moderate heterogeneity; and 76-100% as considerable and Allied Health Literature, ACP Journal Club, DARE, heterogeneity. A P-value >0.05 was considered to reject the International Pharmaceutical Abstracts, old MEDLINE, null hypothesis that the studies were heterogeneous. The MEDLINE Non-Indexed Citations, OVID Healthstar, and effect of publication and selection bias on the summary Cochrane Central Register of Controlled Trials (CENTRAL). estimates was tested using the Begg-Mazumdar bias The search was performed for the years 2000 to December
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