{"title":"Incidence and type of adverse events in patients with cirrhosis receiving terlipressin: A systematic review and meta-analysis.","authors":"Yiyang Shang, Cai'e Wang, Huiyuan Lu, Lu Chai, Wentao Xu, Mauro Bernardi, Xingshun Qi","doi":"10.1097/HC9.0000000000000526","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Terlipressin has been widely used for various cirrhosis-related complications, but its safety profile remains controversial. Herein, this issue was systematically evaluated.</p><p><strong>Methods: </strong>All studies reporting adverse events (AEs) of terlipressin in cirrhosis were screened. Incidences were pooled using a random-effects model. Subgroup analyses were performed according to the patient's characteristics and treatment regimens. Interaction among subgroups was evaluated.</p><p><strong>Results: </strong>Seventy-eight studies with 7257 patients with cirrhosis were included. The pooled incidences of any AEs, treatment-related AEs, any serious AEs (SAEs), treatment-related SAEs, treatment withdrawal due to AEs, and treatment withdrawal due to treatment-related AEs were 31%, 22%, 5%, 5%, 4%, and 4% in patients with cirrhosis receiving terlipressin, respectively. Patients with hepatorenal syndrome had higher incidences of any SAEs (29% vs. 0% vs. 0%, pinteraction = 0.01) and treatment-related SAEs (8% vs. 1% vs. 7%, pinteraction = 0.02) than those with variceal bleeding or ascites. Patients who received terlipressin with human albumin had higher incidences of any SAEs (18% vs. 1%, pinteraction = 0.04) and treatment-related SAEs (7% vs. 0%, pinteraction = 0.09) than those without albumin. Patients with total bilirubin level >4.3 mg/dL had higher incidences of any AEs (69% vs. 24%, pinteraction = 0.02), any SAEs (64% vs. 0%, pinteraction < 0.01), and treatment-related SAEs (8% vs. 1%, pinteraction = 0.04) than those ≤4.3 mg/dL.</p><p><strong>Conclusions: </strong>AEs are common in patients with cirrhosis receiving terlipressin and influenced by clinical scenarios, combination with albumin, and bilirubin levels.</p>","PeriodicalId":12978,"journal":{"name":"Hepatology Communications","volume":null,"pages":null},"PeriodicalIF":5.6000,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11412712/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Hepatology Communications","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/HC9.0000000000000526","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Terlipressin has been widely used for various cirrhosis-related complications, but its safety profile remains controversial. Herein, this issue was systematically evaluated.
Methods: All studies reporting adverse events (AEs) of terlipressin in cirrhosis were screened. Incidences were pooled using a random-effects model. Subgroup analyses were performed according to the patient's characteristics and treatment regimens. Interaction among subgroups was evaluated.
Results: Seventy-eight studies with 7257 patients with cirrhosis were included. The pooled incidences of any AEs, treatment-related AEs, any serious AEs (SAEs), treatment-related SAEs, treatment withdrawal due to AEs, and treatment withdrawal due to treatment-related AEs were 31%, 22%, 5%, 5%, 4%, and 4% in patients with cirrhosis receiving terlipressin, respectively. Patients with hepatorenal syndrome had higher incidences of any SAEs (29% vs. 0% vs. 0%, pinteraction = 0.01) and treatment-related SAEs (8% vs. 1% vs. 7%, pinteraction = 0.02) than those with variceal bleeding or ascites. Patients who received terlipressin with human albumin had higher incidences of any SAEs (18% vs. 1%, pinteraction = 0.04) and treatment-related SAEs (7% vs. 0%, pinteraction = 0.09) than those without albumin. Patients with total bilirubin level >4.3 mg/dL had higher incidences of any AEs (69% vs. 24%, pinteraction = 0.02), any SAEs (64% vs. 0%, pinteraction < 0.01), and treatment-related SAEs (8% vs. 1%, pinteraction = 0.04) than those ≤4.3 mg/dL.
Conclusions: AEs are common in patients with cirrhosis receiving terlipressin and influenced by clinical scenarios, combination with albumin, and bilirubin levels.
背景：特利加压素已被广泛用于治疗各种肝硬化相关并发症，但其安全性仍存在争议。在此，我们对这一问题进行了系统评估：方法：筛选了所有报告特利加压素在肝硬化中不良事件（AEs）的研究。采用随机效应模型对发生率进行汇总。根据患者特征和治疗方案进行亚组分析。评估了亚组之间的相互作用：结果：共纳入 78 项研究，7257 例肝硬化患者。在接受特利加压素治疗的肝硬化患者中，任何AEs、治疗相关AEs、任何严重AEs（SAEs）、治疗相关SAEs、因AEs而停药以及因治疗相关AEs而停药的总发生率分别为31%、22%、5%、5%、4%和4%。与静脉曲张出血或腹水患者相比，肝肾综合征患者的任何SAE（29% vs. 0% vs. 0%，pinteraction = 0.01）和治疗相关SAE（8% vs. 1% vs. 7%，pinteraction = 0.02）发生率更高。与不使用白蛋白的患者相比，接受特利加压素加人血白蛋白的患者发生任何SAE（18% vs. 1%，pinteraction = 0.04）和治疗相关SAE（7% vs. 0%，pinteraction = 0.09）的几率更高。总胆红素水平>4.3 mg/dL的患者与总胆红素水平≤4.3 mg/dL的患者相比，任何AEs（69% vs. 24%，pinteraction = 0.02）、任何SAEs（64% vs. 0%，pinteraction < 0.01）和治疗相关SAEs（8% vs. 1%，pinteraction = 0.04）的发生率均较高：结论：接受特利加压素治疗的肝硬化患者中，AEs很常见，并受临床情况、与白蛋白的结合以及胆红素水平的影响。
期刊介绍：
Hepatology Communications is a peer-reviewed, online-only, open access journal for fast dissemination of high quality basic, translational, and clinical research in hepatology. Hepatology Communications maintains high standard and rigorous peer review. Because of its open access nature, authors retain the copyright to their works, all articles are immediately available and free to read and share, and it is fully compliant with funder and institutional mandates. The journal is committed to fast publication and author satisfaction.
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