Adverse effects of the use of terlipressin infusion compared to boluses in patients with liver cirrhosis and variceal hemorrhage. TERMEX study.

Introduction and Objectives

Cirrhosis is a worldwide health problem as it is a leading cause of mortality. The development of complications in cirrhosis is directly related to the presence of portal hypertension. The risk of annual variceal hemorrhage is 5% for small varices and 15% for large varices. Terlipressin represents a useful drug for this group of patients; classically it has been used in bolus but recent studies have shown that its use in infusion may be superior in bleeding control and with fewer adverse effects. The aim of this study is to define whether there are fewer adverse effects with the use of terlipressin infusion compared to bolus.

Materials and Patients

We include patients in the care of the gastroenterology department from July to December 2023 who met the inclusion criteria were included: >18 years, diagnosed with liver cirrhosis and variceal hemorrhage, who had received terlipressin infusion or bolus. Statistical analysis: descriptive statistics, frequencies and percentages were calculated with Student's t and Mann-Whitney U according to the distribution of the variables; Student's t was used to show differences between groups and chi-square to determine the risk of adverse events with bolus respect terlipressin infusion. Wilcoxon test was applied to show differences between groups.

Results

58 patients were included, all received endoscopic treatment in addition to terlipressin: 16 patients received infusion (27.6%) and 42 (77.4%) received terlipressin in bolus. Female gender predominated with 30 (51.7%), mean age was 55.8 ±10.93 years; the most frequent etiologies of liver cirrhosis were: (MASLD) steatotic liver disease associated with metabolic dysfunction 19 (32.8%), primary biliary cholangitis 12 (20.7%) and MASLD with significant alcohol consume (MetALD) 8 (13.8%). The median MELD was 16 (12-20) points, and the median Child-Pugh Turcotte score was 7 (6-9). Rebleeding occurred in 8 (13.8%) patients and one patient required rescue TIPS (transjugular portosystemic shunt). The percentage of adverse effects was 27.6% (n=16) and therapy was changed to octreotide in 15 (25.9%) patients. The bolus group had 31% (n=13) adverse effects compared to the infusion group where only 3 (18%). The main adverse effect was abdominal pain in 15.5% (n=9). Mortality was 6.9% in our study(n=4).

Conclusions

Adverse effects of terlipressin infusion compared to bolus had no significant difference in the group analyzed. However, there is a tendency in favor of infusion since only 3 patients had adverse effects, we consider that by increasing the sample size, there could be difference in favor of the infusion group.

Ethical declaration: The authors declare that the TERMEX study was submitted to hospital ethics committees, has not been previously published and its publication is authorized by all authors. All of them participated in its preparation to a sufficient extent to be responsible for its content, which is true, not duplicated, without fraud or fabrication.

Declaration of Interests: None.

Funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.