Effect of rifaximin in patients with severe cirrhosis and ascites: A randomized double-blind placebo-controlled clinical trial
Abstract
BACKGROUND&AIMS
Evidence for primary prophylaxis of spontaneous bacterial peritonitis (SBP) is weak and the selection of quinolone-resistant bacteria is currently of concern. Here we present results from a randomized, double-blind, placebo (PBO)-controlled trial to assess whether rifaximin (RFX) has a beneficial effect on 12-month survival in patients with severe cirrhosis and ascites.
METHODS
In this trial conducted at 17 French centers, patients with severe cirrhosis and grade 2 or 3 ascites and ascites protein level <15 g/L were randomized 1:1 to receive RFX 550 mg or PBO BID for 12 months, as primary prophylaxis for SBP. The primary endpoint was 12-month survival. Secondary endpoints were 3- and 6-month survival, incidence of complications of cirrhosis, and safety of RFX.
RESULTS
Between 2018 and 2022, 1957 cirrhotic patients with ascites were screened, 159 were randomized, and 152 (80/72 PBO/RFX) were analyzed in the modified intention-to-treat population. RFX did not improve 12-month (PBO/RFX : 68.1% [95% CI 56.2-78.7] / 56.6% [95% CI 43.5-67.8], p=0.74), 6-month (71.1% [95% CI 59.5-80.0] / 76.4% [95% CI 64.3-84.8]) or 3-month survivals (75.4% [95% CI 64.1-83.5]/82.6% [95% CI 71.4-89.7]), or the incidence of liver complications (SBP, encephalopathy, gastrointestinal bleeding or hepatorenal syndrome). In the per-protocol population (127 patients adherent to the study drug), a lower 12-month cumulative incidence of liver-related events in the RFX group was observed. RFX…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 127 participants or records.
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