Reuters Health Information (2009-08-27): Carvedilol superior to ligation at preventing variceal bleeding
Carvedilol superior to ligation at preventing variceal bleeding
Last Updated: 2009-08-27 8:40:30 -0400 (Reuters Health)
NEW YORK (Reuters Health) - Patients with high-risk esophageal varices treated with the beta-blocker carvedilol had lower rates of first bleeding episodes than patients treated with variceal band ligation, according to results of a randomized controlled trial.
This is "an important finding," the study team notes in a report available online now in Hepatology, as "no other randomized trial has demonstrated drug therapy to have an advantage over variceal band ligation."
With carvedilol, "we have a treatment, which is at least as good as banding," first author Dr. Peter C. Hayes from the Royal Infirmary, Edinburgh, UK, wrote in an email to Reuters Health, "although as with all drugs, compliance, which is highly relevant in a population likely to have many patients with alcoholic liver disease, is going to be important."
The study involved 152 cirrhotic patients from five centers with grade II or larger esophageal varices that had not bled. Seventy-seven patients received carvedilol, starting at 6.25 mg/day and increasing to a target dose of 12.5 mg/day, and 75 were managed with variceal band ligation performed every 2 weeks until eradication using a multibander device.
Baseline characteristics in the groups were similar: 73% had alcoholic liver disease, the median Child-Pugh score was 8, and the median age was 54 years.
On intention-to-treat analysis, carvedilol was "more successful than endoscopic banding in preventing bleeding, although survival was the same with the two treatments," Dr. Hayes noted.
Over a median follow-up of 20 months, varices bled in 8 carvedilol patients and 17 variceal band ligation patients (relative hazard, 0.41).
"Carvedilol was well tolerated, is taken once daily and (from other studies) seems to reduce portal pressure in most patients, which is better than the alternative, propranolol," Dr. Hayes told Reuters Health.
He and his colleagues note in their report that difference in favor of carvedilol in the intention-to-treat analysis has to be interpreted with caution given the difficulties in adherence to variceal band ligation. Thirteen patients in the variceal band ligation arm were noncompliant and were treated with propranolol.
Six patients in the variceal band ligation group bled as a result of banding ulcers. This "high rate" of banding-induced bleeding is "noteworthy," the researchers point out.
The per-protocol analysis revealed no significant differences in the outcomes. There was no evidence of a between-group difference in overall mortality and bleeding-related mortality, although the study was not powered to show a difference in mortality, which at any rate "reflects the underlying severity of liver disease rather than variceal bleeding," the investigators note.
Dr. Hayes and colleagues conclude that carvedilol "can be considered a treatment option for primary prophylaxis of variceal bleeding."
The study was supported by the University of Edinburgh.