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Original article
Carvedilol delays the progression of small oesophageal varices in patients with cirrhosis: a randomised placebo-controlled trial
  1. Ankit Bhardwaj1,
  2. Chandan Kumar Kedarisetty2,
  3. Chitranshu Vashishtha2,
  4. Ajeet Singh Bhadoria1,
  5. Ankur Jindal2,
  6. Guresh Kumar1,
  7. Ashok Choudhary2,
  8. S M Shasthry2,
  9. Rakhi Maiwall2,
  10. Manoj Kumar2,
  11. Vikram Bhatia2,
  12. Shiv Kumar Sarin2
  1. 1Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, Delhi, India
  2. 2Hepatic Hemodynamic Laboratory, Departments of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, Delhi, India
  1. Correspondence to Dr Shiv Kumar Sarin, Department of Hepatology, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi, Delhi 110 070, India; shivsarin{at}gmail.com

Abstract

Background and aims Carvedilol is effective in the primary prophylaxis for large oesophageal varices. We investigated its use in preventing progression of small to large oesophageal varices.

Methods 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.

Results 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.

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

Trial registration number NCT01196507; post-results.

  • PORTAL HYPERTENSION
  • CIRRHOSIS
  • OESOPHAGEAL VARICES

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