P3862 - Meta-Analysis of the Randomized Controlled Trials Comparing Continuous Infusion vs Intravenous Bolus Administration of Terlipressin in Patients With Cirrhosis
Sahib Singh, MD1, Babu Mohan, MD, MS2, Neil Sharma, MD3, Rakesh Vinayek, MD1, Sudhir Dutta, MD1, Michelle Le, MD4, Douglas G. Adler, MD5 1Sinai Hospital, Baltimore, MD; 2University of Utah Health School of Medicine, Salt Lake City, UT; 3Parkview Health, Fort Wayne, IN; 4University of Nebraska Medical Center, Omaha, NE; 5Center for Advanced Therapeutic (CATE), Centura Health, Porter Adventist Hospital, Peak Gastroenterology, Denver, CO
Introduction: Terlipressin (a vasopressin analog) was recently approved for the treatment of hepatorenal syndrome in the United States (US). It is also commonly used for achieving hemostasis in cirrhotic patients with variceal bleeding in other countries. The usual dosing of terlipressin is via intravenous (IV) boluses, but recent randomized controlled trials (RCTs) have shown similar or greater efficacy of continuous infusion with lower adverse event rate. We aimed to perform a meta-analysis of RCTs comparing the two dosing methods of terlipressin in patients with cirrhosis.
Methods: We searched online databases, including Cochrane, Embase, Pubmed and MEDLINE, for RCTs evaluating continuous infusion vs IV bolus administration of terlipressin in patients with cirrhosis complicated with hepatorenal syndrome and/or variceal bleeding. Rebleeding and total adverse events (including peripheral ischemia, circulatory overload etc.) were the clinical endpoints of interest. Standard meta-analysis methods were employed using a random-effects model.
Results: Three RCTs with a total of 267 patients (132 in the continuous infusion group and 135 in the IV bolus group) were included in the final analysis. The mean age of the patients was 51 years, 73% were men, and the mean follow up period was 9 weeks.
As compared to the IV bolus group, the continuous infusion group was associated with significantly lower risk of adverse events (35 vs 57, RR 0.63, 95% CI [0.46-0.86, p = 0.004]) and no heterogeneity was observed between the studies (I² = 0%). Only 2 RCTs reported the rebleeding outcome with 6 events in the continuous infusion group (n=98) and 20 events in the IV bolus group (n=98). The former had lower risk of rebleeding (RR 0.32, 95% CI 0.12-0.88, p = 0.03, I² = 14%).
Discussion: Terlipressin, when given via continuous infusion, may lead to lower rebleeding and adverse events when compared with IV boluses in decompensated cirrhotic patients. This may be due to maintaining steady state drug levels without intermittent ups or downs. Our results, however, should be interpreted with caution due to the lower sample size. Additionally, terlipressin is a costly medication, therefore, a cost-effectiveness analysis would be warranted between continuous and bolus dosing with respect to the outcomes of interest.
Outcome
Result (Risk ratio, 95% Confidence Interval, p value)
Adverse events
0.63, 0.46-0.86, 0.004
Rebleed
0.32, 0.12-0.88, 0.03
Disclosures:
Sahib Singh indicated no relevant financial relationships.
Babu Mohan indicated no relevant financial relationships.
Neil Sharma: Boston Scientific – Consultant. Mauna Kea – Consultant. Medtronic – Consultant. Olympus – Consultant. Steria – Consultant.
Rakesh Vinayek indicated no relevant financial relationships.
Sudhir Dutta indicated no relevant financial relationships.
Michelle Le indicated no relevant financial relationships.
Douglas Adler indicated no relevant financial relationships.
Sahib Singh, MD1, Babu Mohan, MD, MS2, Neil Sharma, MD3, Rakesh Vinayek, MD1, Sudhir Dutta, MD1, Michelle Le, MD4, Douglas G. Adler, MD5. P3862 - Meta-Analysis of the Randomized Controlled Trials Comparing Continuous Infusion vs Intravenous Bolus Administration of Terlipressin in Patients With Cirrhosis, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.