Rifamycin vs placebo for the treatment of acute uncomplicated diverticulitis: A randomised, double‐blind study. Issue 6 (29th November 2020)

• Record Type: Journal Article
• Authors: Kruis, Wolfgang; Poškus, Tomas; Böhm, Günther; Bunganic, Ivan; Rácz, István; Fratila, Ovidiu; Barbara, Giovanni; Wehrum, Sarah; Nacak, Tanju; Greinwald, Roland
• Is Part Of: GastroHep. Volume 2:Issue 6(2020)
• Page Start: 295
• Page End: 308
• Publication Date: 2020-11-29
• Subjects: diverticular disease -- large intestine -- outcome research; Gastroenterology -- Periodicals; Hepatology -- Periodicals; 616.33
• DOI: 10.1002/ygh2.426
• Languages: English
• ISSNs: 2689-3711

Abstract

Abstract: Background: Antibiotic treatment in acute uncomplicated diverticulitis (AUD) is commonplace; however, recent studies have questioned their therapeutic efficacy and placebo‐controlled studies are scarce. Aims: A trial was conducted to study the efficacy and safety of the broad‐spectrum antibiotic Rifamycin SV multi‐matrix (MMX) ® (RIF‐MMX) colon‐specific formulation vs placebo. Methods: A phase 2 trial was conducted in 201 patients with AUD randomised 2:2:1 to receive oral RIF‐MMX 400 mg twice daily (BID) (RIF‐800), 600 mg three times daily (RIF‐1800) or placebo, for 10 days. The primary endpoint was Day‐10 treatment success (required absence of fever, improved left lower quadrant pain, C‐reactive protein (CRP) level improvement and no complications). A key secondary endpoint was complete treatment success, requiring additional normalisation of CRP levels. Results: Day‐10 treatment success occurred more frequently in the RIF‐800 (62.2%) vs RIF‐1800 (49.4%) and placebo groups (47.5%) but fell slightly short of statistical significance ( P = 0.06). RIF‐800 and RIF‐1800 reached significantly ( P < 0.05) higher Day 3 complete treatment success rates (11.0% and 12.7%, respectively) vs placebo (0%). Patients with longer duration of baseline AUD attack tended to show higher complete treatment success rates. Adverse drug reactions, most commonly gastrointestinal disorders, occurred in 7.4%, 9.0% and 12.5% of patients taking RIF‐800, RIF‐1800 and placebo, respectively. Conclusions: RIF‐MMX was well tolerated by most patients, with no safety concerns over 10‐day treatment. Patients with longer duration of baseline AUD symptoms might benefit from a short course of antibiotic treatment with the lower dose of RIF‐MMX, 400 mg BID. ClinicalTrials.gov number NCT01847664 (EudraCT 2012‐003300‐13).