Beta-blockers may help prevent decompensation in patients with cirrhosis and portal hypertension, a recent study found.
Researchers performed a double-blind, randomized controlled trial in eight hospitals in Spain that enrolled patients with compensated cirrhosis and clinically significant portal hypertension, defined as a hepatic venous pressure gradient (HVPG) of at least 10 mm Hg. Clinically significant portal hypertension is considered the strongest predictor of decompensation, the authors noted. Patients with high-risk varices were excluded.
Acute HVPG response to IV propranolol, defined as an HVPG decrease of at least 10%, was assessed. Those who responded were randomly assigned to receive propranolol, up to 160 mg twice daily, or placebo, while nonresponders were randomly assigned to carvedilol, 25 mg/d or less, or placebo. The study's primary end point was incidence of cirrhosis decompensation, defined as ascites, bleeding, or overt encephalopathy, or death. The results were published March 22 by The Lancet.
A total of 201 patients were randomly assigned to a study group between Jan. 18, 2010, and July 31, 2013. Median follow-up was 37 months. One hundred one patients received placebo, and 100 received active treatment. Of the latter, 67 received propranolol and 33 received carvedilol. The primary end point was observed in 16 patients receiving a beta-blocker (16%) and 27 patients receiving placebo (27%), for a hazard ratio of 0.51 (95% CI, 0.26 to 0.97; P=0.041). The difference was attributed largely to reduced incidence of ascites in the treatment groups versus the placebo groups (9 patients versus 20 patients, respectively; hazard ratio, 0.42; 95% CI, 0.19 to 0.92; P=0.0297). Overall, 172 (86%) patients reported adverse events, and rates were similar in each group. Severe adverse events, none fatal, occurred in six patients, four receiving beta-blockers and two receiving placebo.
The authors noted that their results cannot be generalized to all patients with cirrhosis because those with high-risk varices were excluded and that the study was small, among other limitations. However, they concluded that long-term treatment with nonselective beta-blockers may improve decompensation-free survival in patients with compensated cirrhosis and clinically significant portal hypertension, chiefly by decreasing ascites incidence. “This finding might represent a new indication for [beta]-blockers in patients with compensated cirrhosis,” the authors wrote.