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Nonselective beta-blockers do not increase mortality in cirrhosis

New data published in Hepatology showed that nonselective beta-blockers did not increase all-cause or cirrhosis-related mortality in patients with advanced cirrhosis and ascites.

“In 2010, serious concerns about the safety of [nonselective beta-blocker] use in cirrhosis patients with refractory ascites were raised by a single-center observational study including 151 cirrhosis patients with refractory ascites. …The aim of [our] study was to investigate whether [nonselective beta-blocker] treatment [is] associated with increased mortality in cirrhosis patients as well as in a subgroup of decompensated cirrhosis, eg, in patients with refractory ascites who have been the focal point of the discussion of [nonselective beta-blocker] safety,” the researchers wrote.

Researchers analyzed data from three satavaptan clinical trials conducted between 2006 and 2008 in which 1,198 patients with cirrhosis with ascites were followed for 1 year. Cox regression analyses were used to compare all-cause and cirrhosis-related mortality between patients who did and those who did not use nonselective beta-blockers at the time of randomization in the clinical trial. Analysis was conducted controlling for age, sex, MELD score, Child-Pugh score, serum sodium, previous variceal bleeding, cirrhosis etiology and ascites severity.

Results of the analyses showed the patients who used nonselective beta-blockers (n = 559) were more likely to have a history of variceal bleeding compared with patients who did not use them (n = 629). However, beta-blocker users were less likely to have Child-Pugh class C cirrhosis, hyponatremia and refractory ascites.

The 52-week cumulative all-cause mortality rates were similar between the beta-blocker users (23.5%) and nonusers (25.3%; adjusted HR = 0.92; 95% CI, 0.72-1.18). Patients with refractory ascites who used beta-blockers did not have increased mortality (n = 588 patients; adjusted HR = 1.02; 95% CI, 0.74-1.4), nor did any other subgroup.

The use of beta-blockers also did not increase cirrhosis-related mortality in these subgroups (adjusted HR = 1; 95% CI, 0.76-1.31).

During follow-up, 29% of initial beta-blocker users ceased use due to stressful events, which led to an increase in mortality and coincided with hospitalization, variceal bleeding, bacterial infection, and/or development of hepatorenal syndrome.

The researchers concluded: “This large and detailed data set on worldwide non-protocol use of [nonselective beta-blockers] in cirrhosis patients with ascites shows that [nonselective beta-blockers] did not increase mortality. …We cannot clarify whether the decision to discontinue [nonselective beta-blockers] saved these patients or had no impact at all, but our findings suggest that clinicians can continue to use [nonselective beta-blockers] like they did when these randomized trials were conducted in 2006 [to] 2008.” – by Melinda Stevens

Disclosure: The researchers report no relevant financial disclosures.