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A Randomized, Multi-Center, Open-Label Study to Evaluate the Efficacy of Carvedilol vs. Propranolol to Reduce Portal Pressure in Patients With Liver Cirrhosis

Kim, Sang G, MD, PhD1,9; Kim, Tae Y, MD, PhD2,9; Sohn, Joo H, MD, PhD3; Um, Soon H, MD, PhD4; Seo, Yeon S, MD, PhD4; Baik, Soon K, MD, PhD5; Kim, Moon Y, MD, PhD5; Jang, Jae Y, MD, PhD6; Jeong, Soung W, MD, PhD6; Lee, Bora, MS7; Kim, Young S, MD, PhD1; Suk, Ki T, MD, PhD8; Kim, Dong J, MD, PhD8

American Journal of Gastroenterology: November 2016 - Volume 111 - Issue 11 - p 1582–1590
doi: 10.1038/ajg.2016.327
ORIGINAL CONTRIBUTIONS: LIVER
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OBJECTIVES: Propranolol has been used as prophylaxis for variceal bleeding in patients with cirrhosis. More recent data suggest that carvedilol may be more effective for reducing the hepatic venous pressure gradient (HVPG) than propranolol. The primary aim of this study was to evaluate the hemodynamic response to carvedilol compared with propranolol.

METHODS: A total of 110 patients with a baseline HVPG value >12 mm Hg were allocated randomly to receive either carvedilol or propranolol. The HVPG measurement was repeated after 6 weeks of daily medication. The primary end point was a ≥20% fall in HVPG compared with baseline or <12 mm Hg.

RESULTS: The difference in the proportion of responders in the carvedilol (49.1%) vs. propranolol (30.9%) groups did not reach statistical significance in the intention-to-treat analysis (P=0.08). However, among patients with a model for end-stage liver disease (MELD) score ≥15, carvedilol resulted in a significantly greater response than that of propranolol (7/12, 58.3% vs. 0/10, 0%;P=0.005). Similarly, carvedilol was superior to propranolol in patients with Child-Pugh score ≥9 (46.2 vs. 0%;P=0.046). The presence of ascites also had a significant influence on the response rate (51.5 vs. 24.2%;P=0.042). A MELD score ≥15 was the only significant predictor of response among thesepost hocgroups after adjusting for multiple comparisons (P=0.005). Severe adverse events were higher in the carvedilol group although drug-associated adverse events were not different.

CONCLUSIONS: Overall, carvedilol offered no clear advantage over propranolol but it may be more effective in advanced cirrhotic patients with a MELD score≥15 in reducing the portal pressure gradient. However, this potential benefit may come with a cost of increased risk of side-effects and outcome data over a longer term is needed to understand the relative risk benefit.

1Division of Gastroenterology and Hepatology, Soonchunhyang University College of Medicine, Bucheon, Korea

2Institute of Medical Science, Hanyang University, Seoul, Korea

3Division of Gastroenterology and Hepatology, Hanyang University College of Medicine, Guri, Korea

4Division of Gastroenterology and Hepatology, Korea University College of Medicine, Seoul, Korea

5Division of Gastroenterology and Hepatology, Yonsei University College of Medicine, Wonju, Korea

6Division of Gastroenterology and Hepatology, Soonchunhyang University College of Medicine, Seoul, Korea

7Department of Biostatistic Consulting, Soonchunhyang University Bucheon Hospital, Bucheon, Korea

8Division of Gastroenterology and Hepatology, Hallym University College of Medicine, Chuncheon, Korea

9SGK and TYK equally contributed to the manuscript.

Correspondence: Joo H. Sohn, MD, PhD, Division of Gastroenterology and Hepatology, Hanyang University College of Medicine, 153, Gyeongchun-ro, Guri 11923, Korea. E-mail: sonjh@hanyang.ac.kr

Received 01 February 2016; accepted 03 July 2016

Guarantor of the article: Joo H. Sohn, MD, PhD.

Specific author contributions: Contributed equally to study design, data collection, data interpretation, and writing the manuscript: Sang G. Kim and Tae Y. Kim; designed the study, interpreted the data, corrected the drafts, and wrote the final article: Joo H. Sohn; collected data and critically reviewed the manuscript: Soon H. Um, Soon K. Baik, Jae Y. Jang, Young S. Kim, and Dong J. Kim; collected and interpreted the data: Yeon S. Seo, Moon Y. Kim, Soung W. Jeong, and Ki T. Suk; performed the statistical analysis, and critically reviewed the manuscript: Bora Lee. All authors approved the final version of the manuscript.

Financial support: This study was supported by ChongKunDang Pharmaceutical and a grant (no. A050021) of the Good Health R&D Project, Ministry for Health, Welfare and Family Affairs, Republic of Korea. This work was also supported by Soonchunhyang University research fund.

Potential competing interests: None.

SUPPLEMENTARY MATERIAL is linked to the online version of the paper at http://www.nature.com/ajg

© The American College of Gastroenterology 2016. All Rights Reserved.
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