PMID- 37794713 OWN - NLM STAT- MEDLINE DCOM- 20231102 LR - 20231102 IS - 1747-4132 (Electronic) IS - 1747-4124 (Linking) VI - 17 IP - 10 DP - 2023 Jul-Dec TI - Efficacy and safety of tolvaptan in cirrhotic patients: a systematic review and meta-analysis of randomized controlled trials. PG - 1041-1051 LID - 10.1080/17474124.2023.2267421 [doi] AB - 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. FAU - Chai, Lu AU - Chai L AD - Liver Cirrhosis Study Group, Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, China. AD - NMPA Key Laboratory for Research and Evaluation of Drug Regulatory Technology, Shenyang Pharmaceutical University, Shenyang, China. FAU - Li, Zhe AU - Li Z AD - Liver Cirrhosis Study Group, Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, China. AD - NMPA Key Laboratory for Research and Evaluation of Drug Regulatory Technology, Shenyang Pharmaceutical University, Shenyang, China. FAU - Wang, Ting AU - Wang T AD - Liver Cirrhosis Study Group, Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, China. AD - NMPA Key Laboratory for Research and Evaluation of Drug Regulatory Technology, Shenyang Pharmaceutical University, Shenyang, China. FAU - Wang, Ran AU - Wang R AD - Liver Cirrhosis Study Group, Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, China. FAU - Pinyopornpanish, Kanokwan AU - Pinyopornpanish K AD - Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. FAU - Cheng, Gang AU - Cheng G AD - NMPA Key Laboratory for Research and Evaluation of Drug Regulatory Technology, Shenyang Pharmaceutical University, Shenyang, China. FAU - Qi, Xingshun AU - Qi X AUID- ORCID: 0000-0002-9448-6739 AD - Liver Cirrhosis Study Group, Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, China. AD - NMPA Key Laboratory for Research and Evaluation of Drug Regulatory Technology, Shenyang Pharmaceutical University, Shenyang, China. LA - eng PT - Journal Article PT - Meta-Analysis PT - Review PT - Systematic Review DEP - 20231024 PL - England TA - Expert Rev Gastroenterol Hepatol JT - Expert review of gastroenterology & hepatology JID - 101278199 RN - 21G72T1950 (Tolvaptan) RN - 0 (Antidiuretic Hormone Receptor Antagonists) RN - 0 (Benzazepines) SB - IM MH - Humans MH - Tolvaptan/adverse effects MH - *Hyponatremia/diagnosis/drug therapy/epidemiology MH - Antidiuretic Hormone Receptor Antagonists/adverse effects MH - Ascites/diagnosis/drug therapy/etiology MH - Benzazepines/adverse effects MH - Randomized Controlled Trials as Topic MH - Liver Cirrhosis/complications/diagnosis/drug therapy OAB - [Figure: see text]. OABL- eng OTO - NOTNLM OT - Tolvaptan OT - ascites OT - cirrhosis OT - hyponatremia OT - liver EDAT- 2023/10/05 06:44 MHDA- 2023/11/02 12:47 CRDT- 2023/10/05 02:11 PHST- 2023/11/02 12:47 [medline] PHST- 2023/10/05 06:44 [pubmed] PHST- 2023/10/05 02:11 [entrez] AID - 10.1080/17474124.2023.2267421 [doi] PST - ppublish SO - Expert Rev Gastroenterol Hepatol. 2023 Jul-Dec;17(10):1041-1051. doi: 10.1080/17474124.2023.2267421. Epub 2023 Oct 24.