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COMPARISON OF THE INCIDENCE OF SPONTANEOUS BACTERIAL PERITONITIS AND RENAL ADVERSE EVENTS IN PATIENTS WITH CIRRHOSIS ON LACTULOSE VERSUS RIFAXIMIN THERAPY

Date
May 21, 2024

BACKGROUND
Rifaximin and lactulose are widely used in patients with hepatic encephalopathy. Limited data exists on the comparative outcomes regarding spontaneous bacterial peritonitis (SBP), renal adverse events and ER visits in patients with cirrhosis on rifaximin versus lactulose-based therapy. The objective of our study is to compare these outcomes in patients with cirrhosis.
METHODS
We used TRNETX to identify adult patients, with diagnosis of liver cirrhosis using appropriate ICD 9 and 10 codes. Pts were divided into three groups: those on rifaximin monotherapy, lactulose and rifaximin combination therapy, and lactulose monotherapy. We conducted comparisons between pts on rifaximin monotherapy versus lactulose and rifaximin combination therapy. To exclude the contribution of outcomes related to lactulose therapy, we did a head-to-head comparison between the rifaximin monotherapy group and lactulose monotherapy group. The primary outcome was SBP, and the secondary outcomes were adverse renal events (AKI & HRS), hyponatremia, hypernatremia, hyperkalemia, hypokalemia, and ER visits. The clinical outcomes were measured after a 1:1 propensity matching of the groups based on baseline demographics and co-morbidities.
RESULTS
A total of 89,289 & 12,801 pts were identified in lactulose-rifaximin combination therapy and rifaximin monotherapy group respectively, prior to propensity score matching. After propensity matching, each group had 12,801 pts. SBP rates were higher in the lactulose-rifaximin combination therapy cohort as compared to the rifaximin monotherapy cohort [OR 4.61 (95% CI 3.91- 5.43)]. Pts on rifaximin and lactulose combination therapy had higher rates of HRS [OR 6.18 (95% CI 5.31 – 7.20)], hyponatremia [OR 3.02 (95% CI 2.76 – 3.30)], hypernatremia [OR 3.93 (95% CI 3.46 – 4.46)], hypokalemia [OR 2.12 (95% CI 1.94 – 2.32)], hyperkalemia [OR 2.35 (95% CI 2.15 -2.55)], AKI [OR 3.28 (95% CI 3.03 - 5.54)] and ER visits [OR 1.56 (95% CI 1.43 – 1.70)] when compared to those on rifaximin monotherapy. Comparable results were observed when we analyzed the outcomes on lactulose monotherapy versus rifaximin monotherapy cohort (Table)
CONCLUSION
In extensive cohorts matched for propensity, pts with cirrhosis on rifaximin monotherapy exhibited reduced incidences of SBP, renal adverse events, and ER visits compared to those receiving a combination therapy with lactulose and rifaximin or monotherapy with lactulose. It is possible that rifaximin being a nonabsorbable antibiotic offers additional benefits in ameliorating bacterial translocation and systemic endotoxemia in patients with cirrhosis without the cathartic effect caused by lactulose. The decreased incidence of SBP and other adverse events when rifaximin is used as a monotherapy in our study does not hold good when rifaximin is used concurrently with lactulose. Further prospective studies are warranted

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