A systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to assess the effectiveness and safety of Tolvaptan in the context of cirrhosis.

A thorough search of PubMed, EMBASE, and the Cochrane Library databases was conducted to locate RCTs assessing the effectiveness and/or safety of Tolvaptan in cirrhosis. Calculations were performed for risk ratios (RRs) and weighted mean differences (WMDs), and the occurrence of commonly observed adverse events (AEs) was aggregated.

Overall, 8 RCTs were incorporated in the analysis. Tolvaptan demonstrated a significant association with increased rates of ascites improvement (RR = 1.49) and hyponatremia improvement (RR = 1.80), as well as a higher occurrence of any AEs (RR = 1.18), though not serious AEs (RR = 0.86).

Tolvaptan was substantially linked to a decline in body weight (WMD = −1.30 kg) and abdominal circumference (WMD = −1.71 cm), along with elevation in daily urine volume (WMD = 1299.84 mL) and serum sodium concentration (WMD = 2.57 mmol/L). The pooled incidences of pollakiuria, constipation, thirst, and dry mouth, were 17%, 6%, 24%, and 16%, respectively.

Tolvaptan's short-term use was considered favorable for cirrhotic patients with ascites who do not respond adequately to conventional diuretics, as well as for those having hyponatremia.