Table 1.
Clinical trials of terlipressin in patients diagnosed with cirrhosis and hepatorenal syndrome.
| Study No. of Participants |
Dose of Terlipressin | Comparator | Reversal and Survival Benefit with Terlipressin |
Ref. |
|---|---|---|---|---|
| HRS-AKI | ||||
| Moreau R et al. (2002), N = 99 | 3.2 ± 1.3 mg/day infusion | None | 64% reversal | [32] |
| Solanki P et al. (2003), N = 12 in each group | 1 mg every 12 h | Placebo | 41.67% reversal and survival benefit on day 15 | [33] |
| Neri S et al. (2008), N = 26 in each group | 1 mg every 8 h for 5 days, then 0.5 mg every 8 h for 2 weeks with albumin | Albumin | 80% reversal (vs. 19%) | [34] |
| Sharma P et al. (2008), N = 20 in each group | 0.5 mg every 6 h. increasing every third day (in case of no response) to 2 mg every 6 h | Noradrenaline/albumin | 50% reversal in each group Survival was similar on day 15 |
[35] |
| Nazar A et al. (2010), N = 39 | 0.5 to 1 mg every 4 h for 3 days. The dose increased to 2 mg every 4 h with albumin if sCr had not decreased >25% | None | 46% reversal | [36] |
| Singh V et al. (2012), N = 23 in each group | 0.5 mg every 6 h. increasing every third day (in case of no response) to 2 mg every 6 h | Noradrenaline/albumin | 39% reversal (vs. 43.4%) Survival was similar in both groups |
[37] |
| Ghosh S et al. (2013), N = 23 in each group | 0.5 mg every 6 h, increasing every third day when no response achieved to 2 mg every 6 h with albumin | Noradrenaline/albumin | 74% reversal (vs. 74%) No survival benefit |
[38] |
| Cavallin M et al. (2015), N = 27 in terlipressin and 22 in the other group | 3 mg infusion for 24 h, increased to 12 mg over 24 h if no response achieved with albumin | Midodrine/octreotide/albumin | 70.4% reversal (vs. 28.6%) No survival benefits |
[39] |
| Goyal O et al. (2016), N = 41 | 0.5–2 mg every 6 h with albumin | Noradrenaline/albumin | 45% reversal (vs. 47.6%) | [40] |
| Sanyal A et al. (2017), N = 308 patients (terlipressin = 153; placebo = 155) | 1 mg every 6 h. Dose doubled to 2 mg every 6 h when no significant improvement achieved | Placebo | 27% reversal (vs. 14%) Survival benefit on day 90 |
[41] |
| Saif RU et al. (2018), N = 30 in each group | 0.5 mg every 6 h with maximum dose of 4 mg every 6 h with albumin | Noradrenaline/albumin | 57% reversal (vs. 53%) No survival benefit |
[42] |
| Wong F et al. (2021), N = 300 (199 were assigned to the terlipressin + albumin group and 101 to the placebo + albumin group) | 1 mg of terlipressin was administered IV every 5.5 to 6.5 h. Patient could receive up to 2 mg every 6 h on day 4 if no sufficient response achieved | Placebo/albumin | (1) 32% verified reversal (vs. 17%) (2) Reversal without renal replacement therapy by day 30 was 34% (vs. 17%) (3) Reversal among patients with systemic inflammatory response syndrome was 37% (vs. 6%) (4) 26% verified reversal (vs. 17%) without recurrence by day 30 (5) At day 90, liver transplantations had been performed in 23% (vs. 29%) and death occurred in 51% (vs. 45%) |
[28] |
| HRS-AKI and HRS-NAKI | ||||
| Uriz J et al. (2000), N = 9 | 0.5 mg every 4 h. Increased every third day to 1 mg every 4 h and 2 mg every 4 h if no adequate response | None | 78% reversal | [43] |
| Ortega R et al. (2002), N = 21 patients (five were HRS-NAKI) | 0.5–2 mg every 4 h with albumin | None | 57% reversal (vs. 10%) | [44] |
| Alessandria C et al. (2007), N = 22 (12 in terlipressin group) | 1–2 mg every four hours | Noradrenaline/albumin | 83% reversal (vs. 70%) No survival benefit |
[45] |
| Martin-Llahi M et al. (2008), N = 23 in each group | 1 mg every 4 h for 3 days. If no adequate response, the dose was increased to 2 mg every 4 h | Albumin | 43.5% reversal (vs. 8.7%) No survival benefit at day 90 |
[46] |
| Nguyen-Tat M et al. (2019), N = 106 | 4 mg/day IV infusion | None | 46–48% reversal | [47] |