Background & Aims
Esophageal variceal bleed is a major problem in patients with cirrhosis. Endoscopic variceal ligation (EVL) has been shown to be equal to or better than propranolol in preventing first bleed. Carvedilol is a non-selective β blocker with alpha-1 adrenergic blocker activity. Hemodynamic studies have shown carvedilol to be more effective than propranolol at reducing portal pressure. We compared efficacy of carvedilol with EVL for primary prophylaxis of esophageal variceal bleed.
Cirrhotic patients with esophageal varices were randomized to carvedilol 12.5 mg daily or EVL at three university hospitals of Pakistan. End points were esophageal variceal bleeding, death or liver transplant.
Two hundred and nine patients were evaluated. Eighty two and eighty six patients were randomized in carvedilol and EVL arms respectively. Mean age was 48 ± 12.2 years; 122 (72.7%) were males; 89.9% had viral cirrhosis; mean Child-Pugh score was 7.3 ± 1.6 and mean follow up was 13.3 ± 12.1 months (range 1–50 months). Both EVL and carvedilol groups had comparable variceal bleeding rates (8.5% vs. 6.9%), bleed related mortality (4.6% vs. 4.9%) and overall mortality (12.8% vs. 19.5%) respectively. Adverse events in carvedilol group were hypotension (n = 2), requiring cessation of therapy, while transient nausea (n = 18) and dyspnea (n = 30) resolved spontaneously. In the EVL arm, post banding ulcer bleed (n = 1) and chest pain (n = 17), were termed as serious adverse events while transient dysphagia (n = 58) resolved without treatment.
Although our study is underpowered, the findings suggest that carvedilol is probably not superior to EVL in preventing first variceal bleed in patients with viral cirrhosis.
Abbreviations:EVL (esophageal variceal ligation), EVB (esophageal variceal bleed), HCV (hepatitis C virus), HBV (hepatitis B virus), HDV (hepatitis delta virus), PVT (portal vein thrombosis), HCC (hepatocellular carcinoma), GCP (good clinical practice), ER (emergency room), GV (gastric varix), EV (esophageal varix), EKG (electrocardiogram), BCU (bleeding care unit), Hb (hemoglobin), ITT (intention to treat), CI (confidence interval), IHD (ischemic heart disease), HVPG (hepatic venous pressure gradient), EGD (esophago-gastro-duodenoscopy), TIPS (transjugular intrahepatic portosystemic shunt), PSE (porto-systemic encephalopathy)
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Published online: December 02, 2013
Accepted: November 20, 2013
Received in revised form: November 19, 2013
Received: July 19, 2013
© 2013 European Association for the Study of the Liver. Published by Elsevier Inc. All rights reserved.