Non-interventional study evaluating efficacy and tolerability of rifaximin for treatment of uncomplicated diverticular disease

Abstract

Patients with symptomatic uncomplicated diverticular disease represent a spectrum of patients who report recurrent abdominal symptoms, however are lacking substantial colonic inflammation in contrast to patients with acute diverticulitis. This non-interventional study investigated the efficacy and tolerability of rifaximin, a broad-spectrum poorly absorbable antibiotic, in cyclic treatment of these patients. Adult patients with uncomplicated diverticular disease in care of physicians in private practice intended to be treated with rifaximin were included. Patients with acute diverticulitis and symptoms suggestive of more severe intestinal inflammation were excluded. Data of 1,003 patients treated in cycles of 7-10 days per month over a period of 3 months were evaluated. In total, 75 % of patients had more than three episodes of symptoms in the last year before inclusion in the study. However, two-third of patients did not receive any treatment before. Over the 3-month treatment period with rifaximin, all assessed symptoms of diverticular disease, such as abdominal pain, diarrhoea and flatulence, improved significantly. There was an overall good compliance to the scheme of cyclic drug administration of rifaximin. During the study, 24 adverse events in 20 patients were recorded, of which 6 adverse events showed a causal relationship to the use of rifaximin (0.6 %). We conclude that cyclic rifaximin shows good clinical efficacy and tolerability in patients with symptomatic uncomplicated diverticular disease treated in a routine private practice outpatient setting.

Treatment of diverticular disease: an update on latest evidence and clinical implications

“…for 7–10 days) for 3 months. The authors confirmed the beneficial effect of rifaximin on global gastrointestinal symptoms and showed a good safety profile of cyclic administration [ 34 ]. A more recent ‘real-life’ study conducted in an outpatient setting, evaluated the effect of the same therapeutic regimen in 142 SUDD patients: after 3 months, a significant reduction in symptoms was observed, and severity score symptoms reduced from 1.7±0.7 to 0.3±0.1 ( p <0.001) [ 35 ].…”

Russian Non-Interventional Study of the Efficacy and Tolerability of Rifaximin-α Therapy in Patients with Uncomplicated Diverticular Disease under the Conditions of Outpatient Practice

“…Полученные данные в отношении уменьшения интенсивности симптомов НДБ согласуются с результатами контролируемых рандомизированных исследований [13,[20][21][22].…”

“…Ранее проведенные исследования также продемонстрировали, что повторные курсы лечения не приводят к увеличению частоты побочных явлений в сравнении с контрольными группами пациентов, которые не получали рифаксимин-α либо получали плацебо [9]. По данным литературы, частота нежелательных явлений составляет менее 1 % [22,23], что подтверждается полученными нами данными.…”

Cyclic rifaximin therapy effectively prevents the recurrence of symptoms after exacerbation of symptomatic uncomplicated diverticular disease: a retrospective study

“…At the time of our study, only two other publications assessing rifaximin monotherapy were available [14, 15]. The study groups in both reports were different, and they were conducted over a period of 3 months.…”

“…According to the guidelines, treatment with rifaximin should last for at least 12 monthly cycles [11]; however, we do not know for sure what the minimum and maximum number of treatment cycles should be in the different patient groups (first episode, relapse, post-diverticulitis) to maintain the benefits of this regimen. To date, two studies confirming the effectiveness and progressive gain after three treatment cycles in patients with the first episode of SUDD have been published [14, 15].…”