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Multicentre randomised controlled study comparing carvedilol with variceal band ligation in the prevention of variceal rebleeding.
J Hepatol 2014; 61(5):1014-9JH

Abstract

BACKGROUND & AIMS

Rebleeding after an initial oesophageal variceal haemorrhage remains a significant problem despite therapy with band ligation, non-selective β-blockers or a combination of these. Carvedilol is a vasodilating non-selective β-blocker with alpha-1 receptor and calcium channel antagonism. A recent study has suggested it is effective in the prevention of a first variceal bleed. Our aim was to compare oral carvedilol with variceal band ligation (VBL) in the prevention of rebleeding following a first variceal bleed.

METHODS

Patients who were stable 5 days after presentation with a first oesophageal variceal haemorrhage and had not been taking β-blockers were randomised to oral carvedilol or VBL. Patients were followed-up after one week, monthly, then every 3 months. The primary end point was variceal rebleeding on intention-to-treat analysis.

RESULTS

64 patients were randomised, 33 to carvedilol and 31 to VBL. 58 (90.6%) patients had alcohol related liver disease. Age and Child-Pugh score were similar in both groups at baseline. Median follow-up was 26.3 (interquartile range [IQR] 10.2-46.6)months. Compliance was 68% and 65% for carvedilol and VBL respectively (p=0.993) and serious adverse events between the two groups were similar (p=0.968). Variceal rebleeding occurred during follow-up in 12 (36.4%) and 11 (35.5%) patients in the carvedilol and VBL groups, respectively (p=0.857), with 9 (27.3%) and 16 (51.6%) deaths in each group, respectively (p=0.110).

CONCLUSIONS

Carvedilol is not superior to VBL in the prevention of variceal rebleeding. The trend to a survival benefit for patients taking this drug compared with those undergoing banding requires further exploration.

Authors+Show Affiliations

Gastroenterology Unit, Glasgow Royal Infirmary, Glasgow, UK. Electronic address: Adrian.stanley@ggc.scot.nhs.uk.Gastroenterology Unit, Glasgow Royal Infirmary, Glasgow, UK.Liver Unit, Royal Infirmary of Edinburgh, Edinburgh, UK.Gastroenterology Unit, Glasgow Royal Infirmary, Glasgow, UK.Gastroenterology Unit, Gartnavel General Hospital, Glasgow, UK.Liver Unit, Royal Infirmary of Edinburgh, Edinburgh, UK.Liver Unit, Royal Infirmary of Edinburgh, Edinburgh, UK.Liver Unit, Royal Infirmary of Edinburgh, Edinburgh, UK.Gastroenterology Unit, Glasgow Royal Infirmary, Glasgow, UK.Gastroenterology Unit, Glasgow Royal Infirmary, Glasgow, UK.Gastroenterology Unit, Southern General Hospital, Glasgow, UK.Department of Statistics, Strathclyde University, Glasgow, UK.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

24953021

Citation

Stanley, Adrian J., et al. "Multicentre Randomised Controlled Study Comparing Carvedilol With Variceal Band Ligation in the Prevention of Variceal Rebleeding." Journal of Hepatology, vol. 61, no. 5, 2014, pp. 1014-9.
Stanley AJ, Dickson S, Hayes PC, et al. Multicentre randomised controlled study comparing carvedilol with variceal band ligation in the prevention of variceal rebleeding. J Hepatol. 2014;61(5):1014-9.
Stanley, A. J., Dickson, S., Hayes, P. C., Forrest, E. H., Mills, P. R., Tripathi, D., ... Young, D. (2014). Multicentre randomised controlled study comparing carvedilol with variceal band ligation in the prevention of variceal rebleeding. Journal of Hepatology, 61(5), pp. 1014-9. doi:10.1016/j.jhep.2014.06.015.
Stanley AJ, et al. Multicentre Randomised Controlled Study Comparing Carvedilol With Variceal Band Ligation in the Prevention of Variceal Rebleeding. J Hepatol. 2014;61(5):1014-9. PubMed PMID: 24953021.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multicentre randomised controlled study comparing carvedilol with variceal band ligation in the prevention of variceal rebleeding. AU - Stanley,Adrian J, AU - Dickson,Sheila, AU - Hayes,Peter C, AU - Forrest,Ewan H, AU - Mills,Peter R, AU - Tripathi,Dhiraj, AU - Leithead,Joanna A, AU - MacBeth,Kim, AU - Smith,Lyn, AU - Gaya,Daniel R, AU - Suzuki,Harry, AU - Young,David, Y1 - 2014/06/19/ PY - 2014/04/02/received PY - 2014/05/25/revised PY - 2014/06/09/accepted PY - 2014/6/24/entrez PY - 2014/6/24/pubmed PY - 2015/6/27/medline KW - Band ligation KW - Carvedilol KW - Portal hypertension KW - Variceal haemorrhage SP - 1014 EP - 9 JF - Journal of hepatology JO - J. Hepatol. VL - 61 IS - 5 N2 - BACKGROUND & AIMS: Rebleeding after an initial oesophageal variceal haemorrhage remains a significant problem despite therapy with band ligation, non-selective β-blockers or a combination of these. Carvedilol is a vasodilating non-selective β-blocker with alpha-1 receptor and calcium channel antagonism. A recent study has suggested it is effective in the prevention of a first variceal bleed. Our aim was to compare oral carvedilol with variceal band ligation (VBL) in the prevention of rebleeding following a first variceal bleed. METHODS: Patients who were stable 5 days after presentation with a first oesophageal variceal haemorrhage and had not been taking β-blockers were randomised to oral carvedilol or VBL. Patients were followed-up after one week, monthly, then every 3 months. The primary end point was variceal rebleeding on intention-to-treat analysis. RESULTS: 64 patients were randomised, 33 to carvedilol and 31 to VBL. 58 (90.6%) patients had alcohol related liver disease. Age and Child-Pugh score were similar in both groups at baseline. Median follow-up was 26.3 (interquartile range [IQR] 10.2-46.6)months. Compliance was 68% and 65% for carvedilol and VBL respectively (p=0.993) and serious adverse events between the two groups were similar (p=0.968). Variceal rebleeding occurred during follow-up in 12 (36.4%) and 11 (35.5%) patients in the carvedilol and VBL groups, respectively (p=0.857), with 9 (27.3%) and 16 (51.6%) deaths in each group, respectively (p=0.110). CONCLUSIONS: Carvedilol is not superior to VBL in the prevention of variceal rebleeding. The trend to a survival benefit for patients taking this drug compared with those undergoing banding requires further exploration. SN - 1600-0641 UR - https://www.unboundmedicine.com/medline/citation/24953021/Multicentre_randomised_controlled_study_comparing_carvedilol_with_variceal_band_ligation_in_the_prevention_of_variceal_rebleeding_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0168-8278(14)00412-7 DB - PRIME DP - Unbound Medicine ER -