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Treatment with carvedilol improves survival of patients with acute-on-chronic liver failure: a randomized controlled trial.

Abstract

BACKGROUND AND AIMS

In addition to the portal pressure reducing effect, non-selective beta blockers (NSBBs) have possible immunomodulatory and effect in reducing bacterial translocation. Recently, it has been shown that patients who are already on NSBBs should be continued on them (if feasible), if acute-on-chronic liver failure (ACLF) develops. It, however, remains unknown if patients with ACLF and no or small esophageal varices at presentation will benefit from the use of NSBBs. We studied the efficacy and safety of carvedilol in patients with ACLF in reducing mortality, variceal bleeding and non-bleeding complications.

METHODS

136 patients with ACLF (with no or small esophageal varices and HVPG ≥ 12 mmHg) were randomized to either carvedilol (n = 66) or placebo arms (n = 70).

RESULTS

Within 28 days, 7 (10.6%) of 66 patients in the carvedilol group and 17 (24.3%) of 70 in the placebo group died (p= 0.044). Fewer patients in the carvedilol compared to placebo group developed acute kidney injury (AKI) (13.6% vs 35.7%, p = 0.003 and spontaneous bacterial peritonitis (SBP) (6.1% vs 21.4%, p= 0.013). Significantly, more patients in the placebo group had increase in APASL ACLF Research Consortium-ACLF grade (22.9% vs 6.1%, p= 0.007). There was no significant difference in the 90-day transplant-free survival rate and development of AKI, SBP, non-SBP infections (including pneumonia) and variceal bleed within 90 days, between the two groups.

CONCLUSIONS

In ACLF patients with either no or small esophageal varices and HVPG ≥ 12 mmHg, carvedilol leads to improved survival and fewer AKI and SBP events up to 28 days. CLINICALTRIALS.

GOV IDENTIFIER NUMBER

NCT02583698.

Authors+Show Affiliations

Department of Hepatology, Institute of Liver and Biliary Sciences, D1 Vasant Kunj, New Delhi, 110070, India. manojkumardm@gmail.com.Department of Hepatology, Institute of Liver and Biliary Sciences, D1 Vasant Kunj, New Delhi, 110070, India.Department of Hepatology, Institute of Liver and Biliary Sciences, D1 Vasant Kunj, New Delhi, 110070, India.Department of Hepatology, Institute of Liver and Biliary Sciences, D1 Vasant Kunj, New Delhi, 110070, India.Department of Critical Care Medicine, Institute of Liver and Biliary Sciences, New Delhi, India.Department of Critical Care Medicine, Institute of Liver and Biliary Sciences, New Delhi, India.Department of Critical Care Medicine, Institute of Liver and Biliary Sciences, New Delhi, India.Department of Hepatology, Institute of Liver and Biliary Sciences, D1 Vasant Kunj, New Delhi, 110070, India.Department of Hepatology, Institute of Liver and Biliary Sciences, D1 Vasant Kunj, New Delhi, 110070, India.Department of Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, India.Department of Biostatistics, Institute of Liver and Biliary Sciences, New Delhi, India.Department of Hepatology, Institute of Liver and Biliary Sciences, D1 Vasant Kunj, New Delhi, 110070, India.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31541422

Citation

Kumar, Manoj, et al. "Treatment With Carvedilol Improves Survival of Patients With Acute-on-chronic Liver Failure: a Randomized Controlled Trial." Hepatology International, 2019.
Kumar M, Kainth S, Choudhury A, et al. Treatment with carvedilol improves survival of patients with acute-on-chronic liver failure: a randomized controlled trial. Hepatol Int. 2019.
Kumar, M., Kainth, S., Choudhury, A., Maiwall, R., Mitra, L. G., Saluja, V., ... Sarin, S. K. (2019). Treatment with carvedilol improves survival of patients with acute-on-chronic liver failure: a randomized controlled trial. Hepatology International, doi:10.1007/s12072-019-09986-9.
Kumar M, et al. Treatment With Carvedilol Improves Survival of Patients With Acute-on-chronic Liver Failure: a Randomized Controlled Trial. Hepatol Int. 2019 Sep 20; PubMed PMID: 31541422.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Treatment with carvedilol improves survival of patients with acute-on-chronic liver failure: a randomized controlled trial. AU - Kumar,Manoj, AU - Kainth,Sumit, AU - Choudhury,Ashok, AU - Maiwall,Rakhi, AU - Mitra,Lalita G, AU - Saluja,Vandana, AU - Agarwal,Prashant Mohan, AU - Shasthry,Saggere Muralikrishna, AU - Jindal,Ankur, AU - Bhardwaj,Ankit, AU - Kumar,Guresh, AU - Sarin,Shiv K, Y1 - 2019/09/20/ PY - 2019/06/16/received PY - 2019/08/29/accepted PY - 2019/9/22/entrez KW - Acute-on-chronic liver failure KW - Beta blockers KW - Carvedilol JF - Hepatology international JO - Hepatol Int N2 - BACKGROUND AND AIMS: In addition to the portal pressure reducing effect, non-selective beta blockers (NSBBs) have possible immunomodulatory and effect in reducing bacterial translocation. Recently, it has been shown that patients who are already on NSBBs should be continued on them (if feasible), if acute-on-chronic liver failure (ACLF) develops. It, however, remains unknown if patients with ACLF and no or small esophageal varices at presentation will benefit from the use of NSBBs. We studied the efficacy and safety of carvedilol in patients with ACLF in reducing mortality, variceal bleeding and non-bleeding complications. METHODS: 136 patients with ACLF (with no or small esophageal varices and HVPG ≥ 12 mmHg) were randomized to either carvedilol (n = 66) or placebo arms (n = 70). RESULTS: Within 28 days, 7 (10.6%) of 66 patients in the carvedilol group and 17 (24.3%) of 70 in the placebo group died (p= 0.044). Fewer patients in the carvedilol compared to placebo group developed acute kidney injury (AKI) (13.6% vs 35.7%, p = 0.003 and spontaneous bacterial peritonitis (SBP) (6.1% vs 21.4%, p= 0.013). Significantly, more patients in the placebo group had increase in APASL ACLF Research Consortium-ACLF grade (22.9% vs 6.1%, p= 0.007). There was no significant difference in the 90-day transplant-free survival rate and development of AKI, SBP, non-SBP infections (including pneumonia) and variceal bleed within 90 days, between the two groups. CONCLUSIONS: In ACLF patients with either no or small esophageal varices and HVPG ≥ 12 mmHg, carvedilol leads to improved survival and fewer AKI and SBP events up to 28 days. CLINICALTRIALS. GOV IDENTIFIER NUMBER: NCT02583698. SN - 1936-0541 UR - https://www.unboundmedicine.com/medline/citation/31541422/Treatment_with_carvedilol_improves_survival_of_patients_with_acute-on-chronic_liver_failure:_a_randomized_controlled_trial L2 - https://dx.doi.org/10.1007/s12072-019-09986-9 DB - PRIME DP - Unbound Medicine ER -