Ten clinical trials (n=154) were included in the review. There were eight cohort studies (n=121), of which four were randomised; one double-blind, cross-over randomised trial (n=9), and one single-blind, placebo-controlled randomised trial (n=24).
The pooled rate of responder patients (with reversal of hepatorenal syndrome after treatment with terlipressin) was positive and statistically significant, 0.52 (95% CI: 0.42, 0.61, p = 0.00001, 11 trials, n=154), with no significant heterogeneity between the studies. The pooled frequency of responder patients (with hepatorenal syndrome recurrence after terlipressin withdrawal) was 0.55 (95% CI: 0.40, 0.69, p = 0.00001, 6 trials, n=74). Heterogeneity was reported (I2 = 44.3%) but no significant predictive variables were evident. A statistically significant pooled effect on mortality was reported in hepatorenal syndrome patients who were not responders to therapy compared with those who were, OR 5.746 (95% CI: 1.5, 21.9, five trials, n=93).
All sensitivity analyses showed statistically significant improvements in hepatorenal syndrome reversal following terlipressin use. The treatment was well-tolerated and no long term side effects were reported.