REAL-WORLD COMPARATIVE EFFECTIVENESS AND SAFETY OF TERLIPRESSIN VERSUS CONVENTIONAL THERAPY IN HOSPITALIZED ADULTS WITH HEPATORENAL SYNDROME
Author(s)
Precious U. Okeke, PharmD, Kelly R. Reveles, PharmD, PhD, BCPS, BCIDP, Justina Lipscomb, PharmD, BCPS, Laurajo Ryan, PharmD, M.Sc., BCPS;
The University of Texas at Austin, College of Pharmacy, Austin, TX, USA
The University of Texas at Austin, College of Pharmacy, Austin, TX, USA
OBJECTIVES: Hepatorenal syndrome (HRS) is a life-threatening complication of advanced cirrhosis. Although terlipressin was approved in the United States in 2022, real-world comparative evidence versus conventional therapy remains limited. This study compared the real-world effectiveness and safety of terlipressin versus conventional therapy in hospitalized adults with advanced cirrhosis and HRS.
METHODS: We conducted a retrospective cohort study using the TriNetX Research Network, including hospitalized adults with advanced cirrhosis and HRS treated between September 2022 and December 2025. Patients receiving terlipressin were compared with those receiving conventional therapy, defined as midodrine plus octreotide with albumin. Propensity score matching was performed using demographics, comorbidities, and baseline renal and hepatic laboratory markers. Effectiveness outcomes included HRS reversal, defined as serum creatinine less than or equal to 1.5 mg/dL within 3 to 7 days, need for renal replacement therapy (RRT) within 7 days, 30-day all-cause mortality, and 90-day transplant-free survival. Safety outcomes included intensive care unit admission, respiratory failure, severe hyponatremia, and ischemic complications. Risk ratios with 95 percent confidence intervals and p-values were estimated.
RESULTS: After matching, 355 patients were included in each group. HRS reversal was more frequent with terlipressin than with conventional therapy (37.5% vs 30.4%; RR 1.23, 95% CI: 1.00 - 1.51, p = 0.047). Need for RRT within 7 days was lower with terlipressin (3.4% vs 9.3%; RR 0.36, 95% CI: 0.19 - 0.69, p = 0.001). Thirty-day all-cause mortality and 90-day transplant-free survival were similar between groups. ICU admission occurred less often with terlipressin, while other safety outcomes were comparable.
CONCLUSIONS: In real-world practice, terlipressin was associated with improved early renal recovery and reduced short-term RRT use compared with conventional therapy, without differences in mortality or major safety outcomes. These findings support the real-world effectiveness and safety profile of terlipressin and highlight the value of real-world evidence in informing post-approval treatment decisions.
METHODS: We conducted a retrospective cohort study using the TriNetX Research Network, including hospitalized adults with advanced cirrhosis and HRS treated between September 2022 and December 2025. Patients receiving terlipressin were compared with those receiving conventional therapy, defined as midodrine plus octreotide with albumin. Propensity score matching was performed using demographics, comorbidities, and baseline renal and hepatic laboratory markers. Effectiveness outcomes included HRS reversal, defined as serum creatinine less than or equal to 1.5 mg/dL within 3 to 7 days, need for renal replacement therapy (RRT) within 7 days, 30-day all-cause mortality, and 90-day transplant-free survival. Safety outcomes included intensive care unit admission, respiratory failure, severe hyponatremia, and ischemic complications. Risk ratios with 95 percent confidence intervals and p-values were estimated.
RESULTS: After matching, 355 patients were included in each group. HRS reversal was more frequent with terlipressin than with conventional therapy (37.5% vs 30.4%; RR 1.23, 95% CI: 1.00 - 1.51, p = 0.047). Need for RRT within 7 days was lower with terlipressin (3.4% vs 9.3%; RR 0.36, 95% CI: 0.19 - 0.69, p = 0.001). Thirty-day all-cause mortality and 90-day transplant-free survival were similar between groups. ICU admission occurred less often with terlipressin, while other safety outcomes were comparable.
CONCLUSIONS: In real-world practice, terlipressin was associated with improved early renal recovery and reduced short-term RRT use compared with conventional therapy, without differences in mortality or major safety outcomes. These findings support the real-world effectiveness and safety profile of terlipressin and highlight the value of real-world evidence in informing post-approval treatment decisions.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
CO92
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Gastrointestinal Disorders