Carvedilol Plus NUC for Patients With HBV-Compensated Cirrhosis Under Virological Suppression: A Randomized Open-Label Trial
Portal hypertension progression can be relieved after controlling the etiology of liver cirrhosis. Whether beta-blockers could additionally enhance the effects during treatment, particularly for small esophageal varices (EV), was unclear. This study aims to assess the efficacy of add-on carvedilol t...
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| Published in | The American journal of gastroenterology Vol. 119; no. 4; pp. 700 - 711 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
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United States
Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins
01.04.2024
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| Abstract | Portal hypertension progression can be relieved after controlling the etiology of liver cirrhosis. Whether beta-blockers could additionally enhance the effects during treatment, particularly for small esophageal varices (EV), was unclear. This study aims to assess the efficacy of add-on carvedilol to delay EV progression during anti-hepatitis B virus (HBV) treatment in HBV-related cirrhosis.
This randomized controlled trial enrolled patients with virologically suppressed HBV-compensated cirrhosis and small/medium EV. The participants were randomly assigned to receive nucleos(t)ide analog (NUC) or carvedilol 12.5 mg plus NUC (1:1 allocation ratio). The primary end point was the progression rate of EV at 2 years of follow-up.
A total of 238 patients (small EV, 77.3%) were randomized into 119 NUC and 119 carvedilol plus NUC (carvedilol [CARV] combination group). Among them, 205 patients (86.1%) completed paired endoscopies. EV progression rate was 15.5% (16/103) in the NUC group and 12.7% (13/102) in the CARV combination group (relative risk = 0.79, 95% confidence interval 0.36-1.75, P = 0.567). Subgroup analysis on medium EV showed the CARV combination group had a more favorable effect in promoting EV regression (43.5% vs 13.1%, P = 0.022) than NUC alone, but not in small cases ( P = 0.534). The incidence of liver-related events (decompensation, hepatocellular carcinoma, or death/liver transplantation) within 2 years was similar between the 2 groups (11.2% vs 10.4%, P = 0.881).
The overall results did not show statistically significant differences between the added carvedilol strategy and NUC monotherapy in preventing EV progression in patients with virologically suppressed HBV-compensated cirrhosis. However, the carvedilol-added approach might offer improved outcomes specifically for patients with medium EV (NCT03736265). |
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| AbstractList | INTRODUCTION: Portal hypertension progression can be relieved after controlling the etiology of liver cirrhosis. Whether beta-blockers could additionally enhance the effects during treatment, particularly for small esophageal varices (EV), was unclear. This study aims to assess the efficacy of add-on carvedilol to delay EV progression during anti-hepatitis B virus (HBV) treatment in HBV-related cirrhosis. METHODS: This randomized controlled trial enrolled patients with virologically suppressed HBV-compensated cirrhosis and small/medium EV. The participants were randomly assigned to receive nucleos(t)ide analog (NUC) or carvedilol 12.5 mg plus NUC (1:1 allocation ratio). The primary end point was the progression rate of EV at 2 years of follow-up. RESULTS: A total of 238 patients (small EV, 77.3%) were randomized into 119 NUC and 119 carvedilol plus NUC (carvedilol [CARV] combination group). Among them, 205 patients (86.1%) completed paired endoscopies. EV progression rate was 15.5% (16/103) in the NUC group and 12.7% (13/102) in the CARV combination group (relative risk = 0.79, 95% confidence interval 0.36–1.75, P = 0.567). Subgroup analysis on medium EV showed the CARV combination group had a more favorable effect in promoting EV regression (43.5% vs 13.1%, P = 0.022) than NUC alone, but not in small cases ( P = 0.534). The incidence of liver-related events (decompensation, hepatocellular carcinoma, or death/liver transplantation) within 2 years was similar between the 2 groups (11.2% vs 10.4%, P = 0.881). DISCUSSION: The overall results did not show statistically significant differences between the added carvedilol strategy and NUC monotherapy in preventing EV progression in patients with virologically suppressed HBV-compensated cirrhosis. However, the carvedilol-added approach might offer improved outcomes specifically for patients with medium EV (NCT 03736265). INTRODUCTION:Portal hypertension progression can be relieved after controlling the etiology of liver cirrhosis. Whether beta-blockers could additionally enhance the effects during treatment, particularly for small esophageal varices (EV), was unclear. This study aims to assess the efficacy of add-on carvedilol to delay EV progression during anti-hepatitis B virus (HBV) treatment in HBV-related cirrhosis.METHODS:This randomized controlled trial enrolled patients with virologically suppressed HBV-compensated cirrhosis and small/medium EV. The participants were randomly assigned to receive nucleos(t)ide analog (NUC) or carvedilol 12.5 mg plus NUC (1:1 allocation ratio). The primary end point was the progression rate of EV at 2 years of follow-up.RESULTS:A total of 238 patients (small EV, 77.3%) were randomized into 119 NUC and 119 carvedilol plus NUC (carvedilol [CARV] combination group). Among them, 205 patients (86.1%) completed paired endoscopies. EV progression rate was 15.5% (16/103) in the NUC group and 12.7% (13/102) in the CARV combination group (relative risk = 0.79, 95% confidence interval 0.36–1.75, P = 0.567). Subgroup analysis on medium EV showed the CARV combination group had a more favorable effect in promoting EV regression (43.5% vs 13.1%, P = 0.022) than NUC alone, but not in small cases (P = 0.534). The incidence of liver-related events (decompensation, hepatocellular carcinoma, or death/liver transplantation) within 2 years was similar between the 2 groups (11.2% vs 10.4%, P = 0.881).DISCUSSION:The overall results did not show statistically significant differences between the added carvedilol strategy and NUC monotherapy in preventing EV progression in patients with virologically suppressed HBV-compensated cirrhosis. However, the carvedilol-added approach might offer improved outcomes specifically for patients with medium EV (NCT 03736265). abstract-type="graphical"> Portal hypertension progression can be relieved after controlling the etiology of liver cirrhosis. Whether beta-blockers could additionally enhance the effects during treatment, particularly for small esophageal varices (EV), was unclear. This study aims to assess the efficacy of add-on carvedilol to delay EV progression during anti-hepatitis B virus (HBV) treatment in HBV-related cirrhosis. This randomized controlled trial enrolled patients with virologically suppressed HBV-compensated cirrhosis and small/medium EV. The participants were randomly assigned to receive nucleos(t)ide analog (NUC) or carvedilol 12.5 mg plus NUC (1:1 allocation ratio). The primary end point was the progression rate of EV at 2 years of follow-up. A total of 238 patients (small EV, 77.3%) were randomized into 119 NUC and 119 carvedilol plus NUC (carvedilol [CARV] combination group). Among them, 205 patients (86.1%) completed paired endoscopies. EV progression rate was 15.5% (16/103) in the NUC group and 12.7% (13/102) in the CARV combination group (relative risk = 0.79, 95% confidence interval 0.36-1.75, P = 0.567). Subgroup analysis on medium EV showed the CARV combination group had a more favorable effect in promoting EV regression (43.5% vs 13.1%, P = 0.022) than NUC alone, but not in small cases ( P = 0.534). The incidence of liver-related events (decompensation, hepatocellular carcinoma, or death/liver transplantation) within 2 years was similar between the 2 groups (11.2% vs 10.4%, P = 0.881). The overall results did not show statistically significant differences between the added carvedilol strategy and NUC monotherapy in preventing EV progression in patients with virologically suppressed HBV-compensated cirrhosis. However, the carvedilol-added approach might offer improved outcomes specifically for patients with medium EV (NCT03736265). Portal hypertension progression can be relieved after controlling the etiology of liver cirrhosis. Whether beta-blockers could additionally enhance the effects during treatment, particularly for small esophageal varices (EV), was unclear. This study aims to assess the efficacy of add-on carvedilol to delay EV progression during anti-hepatitis B virus (HBV) treatment in HBV-related cirrhosis.INTRODUCTIONPortal hypertension progression can be relieved after controlling the etiology of liver cirrhosis. Whether beta-blockers could additionally enhance the effects during treatment, particularly for small esophageal varices (EV), was unclear. This study aims to assess the efficacy of add-on carvedilol to delay EV progression during anti-hepatitis B virus (HBV) treatment in HBV-related cirrhosis.This randomized controlled trial enrolled patients with virologically suppressed HBV-compensated cirrhosis and small/medium EV. The participants were randomly assigned to receive nucleos(t)ide analog (NUC) or carvedilol 12.5 mg plus NUC (1:1 allocation ratio). The primary end point was the progression rate of EV at 2 years of follow-up.METHODSThis randomized controlled trial enrolled patients with virologically suppressed HBV-compensated cirrhosis and small/medium EV. The participants were randomly assigned to receive nucleos(t)ide analog (NUC) or carvedilol 12.5 mg plus NUC (1:1 allocation ratio). The primary end point was the progression rate of EV at 2 years of follow-up.A total of 238 patients (small EV, 77.3%) were randomized into 119 NUC and 119 carvedilol plus NUC (carvedilol [CARV] combination group). Among them, 205 patients (86.1%) completed paired endoscopies. EV progression rate was 15.5% (16/103) in the NUC group and 12.7% (13/102) in the CARV combination group (relative risk = 0.79, 95% confidence interval 0.36-1.75, P = 0.567). Subgroup analysis on medium EV showed the CARV combination group had a more favorable effect in promoting EV regression (43.5% vs 13.1%, P = 0.022) than NUC alone, but not in small cases ( P = 0.534). The incidence of liver-related events (decompensation, hepatocellular carcinoma, or death/liver transplantation) within 2 years was similar between the 2 groups (11.2% vs 10.4%, P = 0.881).RESULTSA total of 238 patients (small EV, 77.3%) were randomized into 119 NUC and 119 carvedilol plus NUC (carvedilol [CARV] combination group). Among them, 205 patients (86.1%) completed paired endoscopies. EV progression rate was 15.5% (16/103) in the NUC group and 12.7% (13/102) in the CARV combination group (relative risk = 0.79, 95% confidence interval 0.36-1.75, P = 0.567). Subgroup analysis on medium EV showed the CARV combination group had a more favorable effect in promoting EV regression (43.5% vs 13.1%, P = 0.022) than NUC alone, but not in small cases ( P = 0.534). The incidence of liver-related events (decompensation, hepatocellular carcinoma, or death/liver transplantation) within 2 years was similar between the 2 groups (11.2% vs 10.4%, P = 0.881).The overall results did not show statistically significant differences between the added carvedilol strategy and NUC monotherapy in preventing EV progression in patients with virologically suppressed HBV-compensated cirrhosis. However, the carvedilol-added approach might offer improved outcomes specifically for patients with medium EV (NCT03736265).DISCUSSIONThe overall results did not show statistically significant differences between the added carvedilol strategy and NUC monotherapy in preventing EV progression in patients with virologically suppressed HBV-compensated cirrhosis. However, the carvedilol-added approach might offer improved outcomes specifically for patients with medium EV (NCT03736265). |
| Author | Wang, Bingqiong Piao, Hongxin Meng, Fandong Jiang, Wei Guan, Qiushuang Zhou, Jialing Cheng, Jilin Meng, Tongtong Wu, Xiaoning Jia, Jidong Sun, Yameng Ou, Xiaojuan Feng, Bo Li, Ping Wang, Xiaozhong Xu, Xiaoyuan Zhao, Xinyu Li, Minghui Xie, Wen You, Hong Xu, Mingyi Han, Tao Li, Lei Li, Hai Kong, Yuanyuan Chen, Shuyan |
| Author_xml | – sequence: 1 givenname: Bingqiong surname: Wang fullname: Wang, Bingqiong organization: Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, National Clinical Research Center for Digestive Diseases, Beijing, China – sequence: 2 givenname: Jialing surname: Zhou fullname: Zhou, Jialing organization: Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, National Clinical Research Center for Digestive Diseases, Beijing, China – sequence: 3 givenname: Xiaoning orcidid: 0000-0001-5416-712 surname: Wu fullname: Wu, Xiaoning organization: Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, National Clinical Research Center for Digestive Diseases, Beijing, China – sequence: 4 givenname: Yameng surname: Sun fullname: Sun, Yameng organization: Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, National Clinical Research Center for Digestive Diseases, Beijing, China – sequence: 5 givenname: Lei surname: Li fullname: Li, Lei organization: Department of Gastroenterology and Hepatology, Beijing Jishuitan Hospital, Capital Medical University, Beijing, China – sequence: 6 givenname: Ping surname: Li fullname: Li, Ping organization: Department of Hepatology, Tianjin Second People's Hospital, Tianjin, China – sequence: 7 givenname: Minghui orcidid: 0000-0003-3233-5473 surname: Li fullname: Li, Minghui organization: Liver Disease Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China – sequence: 8 givenname: Wei surname: Jiang fullname: Jiang, Wei organization: Department of Gastroenterology and Hepatology, Zhongshan Hospital, Fudan University, Shanghai, China – sequence: 9 givenname: Mingyi surname: Xu fullname: Xu, Mingyi organization: Department of Gastroenterology and Hepatology, Shanghai East Hospital, Shanghai, China – sequence: 10 givenname: Bo surname: Feng fullname: Feng, Bo organization: Hepatology Institute, Peking University People's Hospital, Beijing, China – sequence: 11 givenname: Xiaoyuan surname: Xu fullname: Xu, Xiaoyuan organization: Department of Infectious Disease, Peking University First Hospital, Beijing, China – sequence: 12 givenname: Jilin surname: Cheng fullname: Cheng, Jilin organization: Department of Gastroenterology, Shanghai Public Health Clinical Center, Shanghai, China – sequence: 13 givenname: Wen orcidid: 0000-0002-7314-8175 surname: Xie fullname: Xie, Wen organization: Liver Disease Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China – sequence: 14 givenname: Tao orcidid: 0000-0003-4216-6968 surname: Han fullname: Han, Tao organization: Department of Gastroenterology and Hepatology, Tianjin Union Medical Center Affiliated to Nankai University, Tianjin, China – sequence: 15 givenname: Xiaozhong surname: Wang fullname: Wang, Xiaozhong organization: Department of Hepatology, Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital, Urumqi, Xinjiang, China – sequence: 16 givenname: Hai surname: Li fullname: Li, Hai organization: Department of Gastroenterology, Tianjin Xiqing Hospital, Tianjin, China – sequence: 17 givenname: Hongxin surname: Piao fullname: Piao, Hongxin organization: Department of Infectious Diseases, Affiliated Hospital of Yanbian University, Yanji, China – sequence: 18 givenname: Xinyu orcidid: 0000-0003-4123-3030 surname: Zhao fullname: Zhao, Xinyu organization: Department of Clinical Epidemiology and EBM Unit, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Diseases, Beijing, China – sequence: 19 givenname: Shuyan orcidid: 0000-0003-2400-8413 surname: Chen fullname: Chen, Shuyan organization: Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, National Clinical Research Center for Digestive Diseases, Beijing, China – sequence: 20 givenname: Tongtong surname: Meng fullname: Meng, Tongtong organization: Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, National Clinical Research Center for Digestive Diseases, Beijing, China – sequence: 21 givenname: Qiushuang surname: Guan fullname: Guan, Qiushuang organization: Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, National Clinical Research Center for Digestive Diseases, Beijing, China – sequence: 22 givenname: Fandong orcidid: 0000-0002-2873-575 surname: Meng fullname: Meng, Fandong organization: Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Diseases, Beijing, China – sequence: 23 givenname: Yuanyuan orcidid: 0000-0002-2586-1443 surname: Kong fullname: Kong, Yuanyuan organization: Department of Clinical Epidemiology and EBM Unit, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Diseases, Beijing, China – sequence: 24 givenname: Xiaojuan surname: Ou fullname: Ou, Xiaojuan organization: Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, National Clinical Research Center for Digestive Diseases, Beijing, China – sequence: 25 givenname: Jidong orcidid: 0000-0002-4673-8890 surname: Jia fullname: Jia, Jidong organization: Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, National Clinical Research Center for Digestive Diseases, Beijing, China – sequence: 26 givenname: Hong surname: You fullname: You, Hong organization: Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, National Clinical Research Center for Digestive Diseases, Beijing, China |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/37929952$$D View this record in MEDLINE/PubMed |
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| Snippet | Portal hypertension progression can be relieved after controlling the etiology of liver cirrhosis. Whether beta-blockers could additionally enhance the effects... INTRODUCTION: Portal hypertension progression can be relieved after controlling the etiology of liver cirrhosis. Whether beta-blockers could additionally... INTRODUCTION:Portal hypertension progression can be relieved after controlling the etiology of liver cirrhosis. Whether beta-blockers could additionally... |
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| SubjectTerms | Antiviral Agents - therapeutic use Ascites Beta blockers Blood pressure Carvedilol - therapeutic use Disease prevention Endoscopy Esophagus Hepatitis B Hepatitis B virus Humans Liver cancer Liver cirrhosis Liver Cirrhosis - drug therapy Liver Neoplasms Medical laboratories Medical prognosis Ultrasonic imaging |
| Title | Carvedilol Plus NUC for Patients With HBV-Compensated Cirrhosis Under Virological Suppression: A Randomized Open-Label Trial |
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