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Standard therapy plus simvastatin for cirrhosis increases survival

In the Bleeding Prevention with Simvastatin clinical study, researchers found that the addition of simvastatin to standard therapy for Child-Pugh A and B cirrhosis increased survival, according to published findings.

“In patients with cirrhosis who recover from an acute variceal bleeding episode, the BLEPS trial showed that the addition of simvastatin to nonselective beta-blockers and endoscopic variceal ligation improves survival without reducing the rate of other complications of cirrhosis,” Jaime Bosch, MD, of the Barcelona Hepatic Hemodynamic Laboratory, Liver Unit, Hospital Clínic-IDIBAPS, University of Barcelona, Spain, and colleagues wrote.

The trial included 158 patients with cirrhosis dosed with either 20 mg of simvastatin, increasing to 40 mg after 15 days (n = 69), or placebo (n = 78). All patients were initially treated with standard prophylaxis, a beta-blocker and band ligation, to prevent rebleeding, but then given the simvastatin within 10 days of bleeding. The primary endpoint was a composite of rebleeding and mortality rate, with secondary endpoints consisting of individual components of the composite rebleeding and mortality, according to the research.

Over a follow-up of 2 years, 22 patients in the simvastatin group and 30 patients in the placebo group met the primary endpoint (P = .423). More patients in the placebo group died (22%) vs. patients in the simvastatin group (9%; HR = 0.39; 95% CI, 0.15-0.99).

“Treatment with simvastatin was associated with a 61% reduction in the relative risk of death as compared with placebo,” the researchers wrote.

Rebleeding rates were similar among the groups (28% in the placebo group vs. 25% in the simvastatin group; P = .583).

The most common adverse events were due to complications of cirrhosis including gastrointestinal hemorrhage, ascites and hepatic encephalopathy, and were similar between the two groups.

More patients in the placebo group experienced serious adverse events (53%) compared with the simvastatin group (49%, P = .752). In addition, 11% of patients in the placebo group experienced serious adverse events due to therapy compared with 8% in the simvastatin group (P = .599). Two patients in the simvastatin group, both with advanced liver disease, developed rhabdomyolysis.

“The incidence of rhabdomyolisis in patients receiving 40 mg [per] day of simvastatin was higher than expected,” the researchers wrote.

The use of simvastatin did not increase survival among patients with Child-Pugh class C cirrhosis.

The researchers concluded: “Since survival was not the primary endpoint of the study, these results would require further validation in new randomized controlled trials.” – by Melinda Stevens

Disclosure: The researchers report no relevant financial disclosures.