title: Carvedilol vs. esophageal variceal band ligation in the primary prophylaxis of variceal hemorrhage: a multicentre randomized controlled trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Cirrhotic patients with esophageal varices were randomized to carvedilol 12.5mg daily or EVL at three university hospitals of Pakistan. End points were esophageal variceal bleeding, death or liver transplant.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Section of Gastroenterology, Aga Khan University, Karachi, Pakistan. Electronic address: hasnain.alishah@aku.edu.
authors.forename: Hasnain Ali
authors.initials: HA
authors.lastname: Shah
authors.affiliation: National Institute of Liver & GI Diseases, Dow University of Health Sciences, Karachi, Pakistan.
authors.forename: Zahid
authors.initials: Z
authors.lastname: Azam
authors.affiliation: Section of Gastroenterology, Aga Khan University, Karachi, Pakistan.
authors.forename: Javeria
authors.initials: J
authors.lastname: Rauf
authors.affiliation: Section of Gastroenterology, Aga Khan University, Karachi, Pakistan.
authors.forename: Shahab
authors.initials: S
authors.lastname: Abid
authors.affiliation: Section of Gastroenterology, Aga Khan University, Karachi, Pakistan.
authors.forename: Saeed
authors.initials: S
authors.lastname: Hamid
authors.affiliation: Section of Gastroenterology, Aga Khan University, Karachi, Pakistan.
authors.forename: Wasim
authors.initials: W
authors.lastname: Jafri
authors.affiliation: National Institute of Liver & GI Diseases, Dow University of Health Sciences, Karachi, Pakistan.
authors.forename: Abdullah
authors.initials: A
authors.lastname: Khalid
authors.affiliation: Section of Gastroenterology, Aga Khan University, Karachi, Pakistan.
authors.forename: Faisal Wasim
authors.initials: FW
authors.lastname: Ismail
authors.affiliation: Section of Gastroenterology, Aga Khan University, Karachi, Pakistan.
authors.forename: Om
authors.initials: O
authors.lastname: Parkash
authors.affiliation: Section of Gastroenterology, Aga Khan University, Karachi, Pakistan.
authors.forename: Amna
authors.initials: A
authors.lastname: Subhan
authors.affiliation: Medical Unit VII, Jinnah Postgraduate Medical Centre, Karachi, Pakistan.
authors.forename: Syed Mohammad
authors.initials: SM
authors.lastname: Munir
mesh_terms: D058668:Adrenergic alpha-1 Receptor Antagonists / Q000009:adverse effects / Q000627:therapeutic use; D000319:Adrenergic beta-Antagonists / Q000009:adverse effects / Q000627:therapeutic use; D000328:Adult; D002227:Carbazoles / Q000009:adverse effects / Q000627:therapeutic use*; D000077261:Carvedilol; D004932:Esophageal and Gastric Varices / Q000188:drug therapy* / Q000209:etiology / Q000601:surgery*; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000401:mortality / Q000517:prevention & control*; D006525:Hepatitis, Viral, Human / Q000150:complications; D006801:Humans; D006975:Hypertension, Portal / Q000150:complications; D008026:Ligation / Q000009:adverse effects / Q000379:methods; D008103:Liver Cirrhosis / Q000150:complications; D008297:Male; D008875:Middle Aged; D011412:Propanolamines / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D058668:Adrenergic alpha-1 Receptor Antagonists; D000319:Adrenergic beta-Antagonists; D002227:Carbazoles; D011412:Propanolamines; D000077261:Carvedilol
keywords: Carvedilol; Cirrhosis; Endoscopic variceal ligation; Portal hypertension; Primary prophylaxis; Randomized controlled trial; Variceal hemorrhage