Background and study aims: Up to our knowledge, no study was performed on primary prophylaxis of variceal ‎bleeding in cirrhosis with systemic arterial hypertension. So, we will evaluate the safety ‎and efficacy of carvedilol versus endoscopic band ligation (EBL) for the primary ‎prophylaxis of variceal bleeding in hypertensive cirrhotic patients‎.
Patients and Methods: ‎In this randomized controlled trial, 306 cirrhotic hypertensive patients‏ ‏with large and/or ‎risky esophageal varices were randomized into EBL and carvedilol groups. Carvedilol ‎was given orally at an initial dose of 6.25 mg twice daily, and titrated up to achieve a ‎normotensive response. When maximum of 25mg twice daily was given without ‎satisfactory control of blood pressure, diuretic and enalapril was added.‎
Results: Variceal bleeding within a follow up period of one year was found to be 1.3% in EBL ‎group versus 2.6% in carvedilol group without statistically significant difference ‎‎(P=0.680).  In carvedilol group, systolic blood pressure, diastolic blood pressure and ‎mean arterial pressure were significantly decreased at 3 months of follow up till the end ‎of the study, while heart rate was significantly decreased at 9 months of follow up till ‎the end of the study when compared with the baseline (P <0.001). Adverse events were ‎significantly higher in the EBL group (25.49%) than carvedilol group (10.46%) (P< ‎‎0.05)‎‎‎‎‎‎‎‎‎.
Conclusion: Carvedilol was safe and effective in the primary prophylaxis of esophageal variceal ‎bleeding in cirrhotic patients with systemic arterial hypertension ‎‎.