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| |  Otilonium Bromide Relieves Irritable Bowel Syndrome Symptoms: Presented at GASTRO 2009 (UEGW/WCOG) By Sara Freeman LONDON-- December 1, 2009 -- The antispasmodic agent otilonium bromide reduces the frequency of abdominal pain and the severity of abdominal bloating associated with irritable bowel syndrome (IBS) to a significantly greater extent than placebo, noted researchers presenting here at GASTRO 2009. Patients taking the antispasmodic therapy are less likely than placebo-treated patients to experience symptomatic relapse as well, according to data from the 356-patient Otilonium Bromide in Irritable Bowel Syndrome (OBIS) study, reported here on November 24. “Antispasmodics are widely used in Europe in the treatment of irritable bowel syndrome,” said Jan Tack, MD, PhD, University Hospitals Leuven, Leuven, Belgium. Dr. Tack noted that there have been many studies reporting the benefits of such therapy in IBS patients; however, few have included large numbers of patients, or used a randomised, double-blind study design. The primary aim of the present study, was to conduct a larger, more robustly designed, international study to confirm the superiority of otilonium bromide over placebo in the control of abdominal pain in adult patients with IBS. The study ran for a total of 27 weeks: after a 2-week placebo run-in period, 179 patients were randomised to treatment with otilonium bromide 40 mg, and 177 to placebo, both given 3 times a day for 15 weeks and then stopped. Patients who completed the treatment phase (n = 125) were then followed up for a further 10 weeks. The primary endpoint was a change in the weekly frequency of abdominal pain from baseline until the end of the 15-week treatment period. The reduction in this primary endpoint was significantly greater in the otilonium bromide-treated patients compared with placebo, with mean changes of -0.65 and -0.90, respectively (P = .038). A greater reduction in the severity of abdominal bloating from baseline to the end of the 15-week treatment period (a secondary endpoint) was also noted in the otilonium bromide-treated patients than in placebo subjects (-1.15 vs -0.91, respectively; P = .021). Significantly greater reductions were also seen at 10 weeks’ active versus placebo treatment (P = .037). Another secondary endpoint, change in patient-assessed global efficacy evaluation, showed a benefit of the antispasmodic treatment over placebo (1.29 vs 1.04, P = .04). No significant differences were found, however, in terms of quality of life, severity of pain assessment, stool frequency or consistency, or the presence of mucus in the stool. Dr. Tack reported that fewer actively treated patients withdrew from the follow-up part of the study due to symptom relapse: 10.4% (n = 69) of otilonium bromide- versus 27.2% of (n = 56) placebo-treated patients withdrew for this reason (P = .009). Safety evaluations showed no changes in vital signs or relevant clinical laboratory parameters. There were no serious adverse events, and no significant difference in the total number of adverse events reported by otilonium bromide- and placebo-treated subjects (24% vs 17%). “Possibly 1 treatment-related adverse event occurred in only 1.7% of the otilonium bromide and 0% in the placebo group -- this was not significant,” Dr. Tack reported. He concluded that otilonium bromide is generally well tolerated and “superior to placebo in reduction of frequency of abdominal pain, severity of abdominal bloating and protecting from symptom relapse in patients with IBS.” These study findings, he added, “further confirm that patients with IBS can improve during and following treatment with otilonium bromide.” GASTRO 2009 is jointly organised by the United European Gastroenterology Federation (UEGF), the World Gastroenterology Organisation (WGO), the World Organisation of Digestive Endoscopy (OMED), and the British Society of Gastroenterology (BSG). [Presentation title: Otilonium Bromide Improves Frequency of Abdominal Pain, Severity of Distention and Time to Relapse in Patients With Irritable Bowel Syndrome. OBIS Study Working Group. Abstract OP279]
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