Efficacy and safety of tolvaptan in cirrhotic patients: a systematic review and meta-analysis of randomized controlled trials.

IF 3.8 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Expert Review of Gastroenterology & Hepatology Pub Date : 2023-07-01 Epub Date: 2023-10-24 DOI:10.1080/17474124.2023.2267421

Lu Chai, Zhe Li, Ting Wang, Ran Wang, Kanokwan Pinyopornpanish, Gang Cheng, Xingshun Qi

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引用次数: 0

Abstract

Background and aims: Tolvaptan has been approved for the management of cirrhosis-related complications according to the Japanese and Chinese practice guidelines, but not the European or American practice guidelines in view of FDA warning about its hepatotoxicity. This study aimed to systematically evaluate its efficacy and safety in cirrhosis.

Methods: The PubMed, EMBASE, and Cochrane library databases were searched to identify randomized controlled trials (RCTs) evaluating the efficacy and/or safety of tolvaptan in cirrhosis. Risk ratios (RRs) and weight mean differences (WMDs) were calculated. The incidence of common adverse events (AEs) was pooled.

Results: Eight RCTs were included. Tolvaptan was significantly associated with higher rates of improvement of ascites (RR = 1.49, P < 0.001) and hyponatremia (RR = 1.80, P = 0.005) and incidence of any AEs (RR = 1.18, P = 0.003), but not serious AEs (RR = 0.86, P = 0.410). Tolvaptan was significantly associated with reductions in body weight (WMD = -1.30 kg, P < 0.001) and abdominal circumference (WMD = -1.71 cm, P < 0.001), and increases in daily urine volume (WMD = 1299.84 mL, P < 0.001) and serum sodium concentration (WMD = 2.57 mmol/L, P < 0.001). The pooled incidences of dry mouth, thirst, constipation, and pollakiuria were 16%, 24%, 6%, and 17%, respectively.

Conclusion: Short-term use of tolvaptan may be considered in cirrhotic patients with ascites who have inadequate response to conventional diuretics and those with hyponatremia.

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Tolvaptan治疗肝硬化患者的疗效和安全性：随机对照试验的系统综述和荟萃分析。

背景和目的：托伐普坦已根据日本和中国的实践指南被批准用于肝硬化相关并发症的治疗，但鉴于美国食品药品监督管理局对其肝毒性的警告，欧洲或美国的实践指南未被批准。本研究旨在系统评价其治疗肝硬化的疗效和安全性。方法：检索PubMed、EMBASE和Cochrane图书馆数据库，以确定评估托伐普坦治疗肝硬化的疗效和/或安全性的随机对照试验（RCT）。计算风险比（RR）和权重平均差（WMD）。合并常见不良事件（AE）的发生率。结果：纳入8项随机对照试验。托伐普坦与较高的腹水改善率显著相关（RR = 1.49，P P = 0.005）和任何AE的发生率（RR = 1.18，P = 0.003），但不严重AE（RR = 0.86，P = 0.410）。托伐普坦与体重减轻显著相关（WMD=-1.30 kg，P P P P 结论：对于对常规利尿剂反应不足的肝硬化腹水患者和低钠血症患者，可考虑短期使用托伐普坦。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Review of Gastroenterology & Hepatology GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

6.80

自引率

2.60%

发文量

审稿时长

6-12 weeks

期刊介绍： The enormous health and economic burden of gastrointestinal disease worldwide warrants a sharp focus on the etiology, epidemiology, prevention, diagnosis, treatment and development of new therapies. By the end of the last century we had seen enormous advances, both in technologies to visualize disease and in curative therapies in areas such as gastric ulcer, with the advent first of the H2-antagonists and then the proton pump inhibitors - clear examples of how advances in medicine can massively benefit the patient. Nevertheless, specialists face ongoing challenges from a wide array of diseases of diverse etiology.