Carvedilol delays the progression of small oesophageal varices in patients with cirrhosis: a randomised placebo-controlled trial.
Carvedilol is effective in the primary prophylaxis for large oesophageal varices. We investigated its use in preventing progression of small to large oesophageal varices.



Consecutive cirrhotics with small oesophageal varices were prospectively randomised to either carvedilol (n=70) or placebo (n=70) and followed up for a minimum of 24 months. Endoscopy was done at baseline and six monthly intervals. Hepatic vein pressure gradient (HVPG) was measured at baseline and at 12 months. The primary endpoint was development of large varices.



Baseline characteristics in two groups were comparable. The predominant aetiology of cirrhosis was non-alcoholic fatty liver disease in both the groups. The mean dose of carvedilol administered was 12±1.67 mg/day and the target heart rate achieved was 58±3 bpm. A higher proportion of patients in carvedilol group had non-progression to large varices than placebo (79.4% vs 61.4%; p=0.04); the mean time of non-progression to large varices was 20.8 months (95% CI 19.4 to 22.4) in carvedilol group and 18.7 months (95% CI 17.1 to 20.4) in placebo group (p=0.04). There was a modest reduction of HVPG at 1 year in carvedilol group (-8.64%) compared with placebo (+0.33%) (p=0.22). None of the patients in either group died of variceal bleeding or liver-related causes. No major adverse events were observed in either group.



Carvedilol is safe and effective in delaying the progression of small to large oesophageal varices in patients with cirrhosis.



NCT01196507; post-results.
Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, Delhi, India.
Ankit
A
Bhardwaj
Hepatic Hemodynamic Laboratory, Departments of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, Delhi, India.
Chandan Kumar
CK
Kedarisetty
Hepatic Hemodynamic Laboratory, Departments of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, Delhi, India.
Chitranshu
C
Vashishtha
Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, Delhi, India.
Ajeet Singh
AS
Bhadoria
Hepatic Hemodynamic Laboratory, Departments of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, Delhi, India.
Ankur
A
Jindal
Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, Delhi, India.
Guresh
G
Kumar
Hepatic Hemodynamic Laboratory, Departments of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, Delhi, India.
Ashok
A
Choudhary
Hepatic Hemodynamic Laboratory, Departments of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, Delhi, India.
S M
SM
Shasthry
Hepatic Hemodynamic Laboratory, Departments of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, Delhi, India.
Rakhi
R
Maiwall
Hepatic Hemodynamic Laboratory, Departments of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, Delhi, India.
Manoj
M
Kumar
Hepatic Hemodynamic Laboratory, Departments of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, Delhi, India.
Vikram
V
Bhatia
Hepatic Hemodynamic Laboratory, Departments of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, Delhi, India.
Shiv Kumar
SK
Sarin
D058668:Adrenergic alpha-1 Receptor Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D002227:Carbazoles / Q000009:adverse effects / Q000627:therapeutic use*; D000077261:Carvedilol; D018450:Disease Progression; D018572:Disease-Free Survival; D016099:Endoscopy, Gastrointestinal; D004932:Esophageal and Gastric Varices / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006503:Hepatic Veins / Q000503:physiopathology; D006801:Humans; D008103:Liver Cirrhosis / Q000150:complications; D008297:Male; D008875:Middle Aged; D011412:Propanolamines / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D015996:Survival Rate; D014690:Venous Pressure / Q000187:drug effects
D058668:Adrenergic alpha-1 Receptor Antagonists; D002227:Carbazoles; D011412:Propanolamines; D000077261:Carvedilol
CIRRHOSIS; OESOPHAGEAL VARICES; PORTAL HYPERTENSION