title: Randomized controlled trial of carvedilol versus variceal band ligation for the prevention of the first variceal bleed.
abstract: Current therapy for preventing the first variceal bleed includes beta-blocker and variceal band ligation (VBL). VBL has lower bleeding rates, with no differences in survival, whereas beta-blocker therapy can be limited by side effects. Carvedilol, a non-cardioselective vasodilating beta-blocker, is more effective in reducing portal pressure than propranolol; however, there have been no clinical studies assessing the efficacy of carvedilol in primary prophylaxis. The goal of this study was to compare carvedilol and VBL for the prevention of the first variceal bleed in a randomized controlled multicenter trial. One hundred fifty-two cirrhotic patients from five different centers with grade II or larger esophageal varices were randomized to either carvedilol 12.5 mg once daily or VBL performed every 2 weeks until eradication using a multibander device. Seventy-seven patients were randomized to carvedilol and 75 to VBL. Baseline characteristics did not differ between the groups (alcoholic liver disease, 73%; median Child-Pugh score, 8; median age, 54 years; median follow-up, 20 months). On intention-to-treat analysis, carvedilol had lower rates of the first variceal bleed (10% versus 23%; relative hazard 0.41; 95% confidence interval 0.19-0.96 [P = 0.04]), with no significant differences in overall mortality (35% versus 37%, P = 0.71), and bleeding-related mortality (3% versus 1%, P = 0.26). Six patients in the VBL group bled as a result of banding ulcers. Per-protocol analysis revealed no significant differences in the outcomes.
  
  
  CONCLUSIONS
  Carvedilol is effective in preventing the first variceal bleed. Carvedilol is an option for primary prophylaxis in patients with high-risk esophageal varices.
authors.affiliation: Royal Infirmary, Edinburgh, United Kingdom.
authors.forename: Dhiraj
authors.initials: D
authors.lastname: Tripathi
authors.forename: James W
authors.initials: JW
authors.lastname: Ferguson
authors.forename: Narendra
authors.initials: N
authors.lastname: Kochar
authors.forename: Joanna A
authors.initials: JA
authors.lastname: Leithead
authors.forename: George
authors.initials: G
authors.lastname: Therapondos
authors.forename: Norma C
authors.initials: NC
authors.lastname: McAvoy
authors.forename: Adrian J
authors.initials: AJ
authors.lastname: Stanley
authors.forename: Ewan H
authors.initials: EH
authors.lastname: Forrest
authors.forename: William S
authors.initials: WS
authors.lastname: Hislop
authors.forename: Peter R
authors.initials: PR
authors.lastname: Mills
authors.forename: Peter C
authors.initials: PC
authors.lastname: Hayes
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D002227:Carbazoles / Q000627:therapeutic use*; D000077261:Carvedilol; D004932:Esophageal and Gastric Varices / Q000401:mortality / Q000517:prevention & control* / Q000601:surgery; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000401:mortality / Q000517:prevention & control*; D006801:Humans; D006975:Hypertension, Portal / Q000150:complications* / Q000188:drug therapy; D008026:Ligation / Q000379:methods; D008297:Male; D008875:Middle Aged; D011412:Propanolamines / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000319:Adrenergic beta-Antagonists; D002227:Carbazoles; D011412:Propanolamines; D000077261:Carvedilol