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Rifaximin Reduces the Number and Severity of Intestinal Lesions Associated With Use of Nonsteroidal Anti-Inflammatory
Carmelo Scarpignato1, Werner Dolak2, Angel Lanas3
1Clinical Pharmacology and Digestive Pathophysiology Unit, Department of Clinical and Experimental Medicine, University of Parma, Parma, Italy.
Abstract:
The intestinal microbiota might contribute to enteropathy associated with use of nonsteroidal anti-inflammatory drugs (NSAIDs), but there have been few human studies of this association. We performed a placebo-controlled study to determine whether a delayed-release antibiotic formulation (rifaximin-extended intestinal release [EIR]) prevents the development of intestinal lesions in subjects taking daily NSAIDs. Sixty healthy volunteers (median age, 26 y; 42% female) were given the NSAID diclofenac (75 mg twice daily) plus omeprazole (20 mg once daily), and either rifaximin-EIR (400 mg) or placebo, twice daily for 14 days. Subjects were assessed by videocapsule endoscopy at baseline and after 2 weeks of treatment. The primary end point was the proportion of subjects developing at least 1 small-bowel mucosal break at week 2. Secondary end points were the change in the mean number of mucosal lesions and the number of subjects with large erosions and/or ulcers after 14 days of exposure. We detected mucosal breaks in 20% of subjects given rifaximin and in 43% of subjects given placebo (P = .05 in the post hoc sensitivity analysis). None of the subjects in the rifaximin group developed large lesions, compared with 9 subjects in the placebo group (P < .001). Our findings indicate that intestinal bacteria contribute to the development of NSAID-associated enteropathy in human beings. Clinical trial no: EudraCT 2013-000730-36.
Insights
The intestinal microbiota contributes to NSAID-induced enteropathy. Rifaximin-extended intestinal release significantly reduced small-bowel mucosal breaks and prevented large lesions in healthy volunteers taking NSAIDs.
Area of Science:
- Gastroenterology
- Microbiology
- Pharmacology
Background:
- Nonsteroidal anti-inflammatory drugs (NSAIDs) can cause intestinal injury (enteropathy).
- The role of the intestinal microbiota in NSAID-associated enteropathy is not well understood in humans.
- Few human studies have investigated interventions targeting the gut microbiome to prevent NSAID enteropathy.
Purpose of the Study:
- To investigate if a delayed-release antibiotic, rifaximin-extended intestinal release (EIR), can prevent NSAID-induced intestinal lesions.
- To evaluate the effect of rifaximin-EIR on small-bowel mucosal breaks and erosions/ulcers in healthy volunteers.
Main Methods:
- A 14-day, placebo-controlled trial involving 60 healthy volunteers.
- Participants received diclofenac (NSAID) plus omeprazole, with either rifaximin-EIR or placebo twice daily.
- Videocapsule endoscopy assessed small-bowel mucosal breaks and lesions at baseline and after 2 weeks.
Main Results:
- 20% of subjects receiving rifaximin-EIR developed mucosal breaks versus 43% in the placebo group (post hoc analysis P=.05).
- No subjects in the rifaximin-EIR group developed large erosions or ulcers.
- 9 subjects in the placebo group developed large lesions (P < .001).
Conclusions:
- Intestinal bacteria play a role in the development of NSAID-associated enteropathy.
- Rifaximin-EIR shows potential in preventing NSAID-induced small-bowel mucosal injury.
- This study supports the contribution of the gut microbiome to NSAID enteropathy in humans.
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