The American journal of gastroenterology · 2024
A Phase II, Multicentric, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of Efficacy and Safety of Rifamycin SV-MMX 600 mg Tablets Administered Three or Two Times Daily to Patients With Diarrhea-Predominant Irritable Bowel Syndrome.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование II фазыПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Balsiger Lukas Michaja, Santos Javier, Serra Jordi, Piessevaux Hubert, Baert Didier, Storr Martin, Basilisco Guido, Mazzetti Alessandro, Moro Luigi, Gerloni Mara, Longo Luigi, Gentili Alessandra, Tack Jan
Аннотация
INTRODUCTION: Treatment with nonresorbable antibiotics is effective in diarrhea-predominant irritable bowel syndrome (IBS-D). Multimatrix (MMX) formulations ensure targeted drug delivery to the mid-distal small bowel and colon-traditionally considered the origin of IBS symptoms. To assess the efficacy of rifamycin SV-MMX for the treatment of IBS-D.
METHODS: Randomized controlled trial in patients with IBS-D (Rome IV). Patients received rifamycin SV-MMX 600 mg (b.i.d = 1200 mg/d or t.i.d = 1800 mg/d) or placebo for 2 weeks. Primary end point was responder rate in the first treatment week on the full analysis set (FAS). Response was defined as decrease in average abdominal pain ≥ 30% AND ≥50% reduction of days with stool type 6 or 7 based on daily reporting.
RESULTS: A total of 279 patients were randomized (=ITT), and 264 of were included in the FAS. More patients with rifamycin SV-MMX b.i.d (22/88, 25.00%) met the primary end point than t.i.d (10/81, 12.35%) or placebo (9/95, 9.47%) in both FAS and ITT. Adjusted odds ratio (AOR) for b.i.d. vs placebo was 3.26 (95% confidence interval (CI): 1.39-7.67; P = 0.007) and for t.i.d. vs b.i.d. 0.40 (95% CI: 0.17-0.92; P = 0.031). After treatment, the percentage of monthly global responders was higher in the b.i.d. group vs placebo in the first month (64.2% vs 46.6%, adjusted odds ratio = 2.14 95% CI: 1.15; 4.00; P = 0.0173) and first 2 months.
DISCUSSION: Rifamycin SV-MMX 600 mg b.i.d. was more effective than placebo and t.i.d. dosing in the first week of treatment. Two months after treatment, rifamycin SV-MMX 600 mg b.i.d. provided more global symptom relief than placebo.
METHODS: Randomized controlled trial in patients with IBS-D (Rome IV). Patients received rifamycin SV-MMX 600 mg (b.i.d = 1200 mg/d or t.i.d = 1800 mg/d) or placebo for 2 weeks. Primary end point was responder rate in the first treatment week on the full analysis set (FAS). Response was defined as decrease in average abdominal pain ≥ 30% AND ≥50% reduction of days with stool type 6 or 7 based on daily reporting.
RESULTS: A total of 279 patients were randomized (=ITT), and 264 of were included in the FAS. More patients with rifamycin SV-MMX b.i.d (22/88, 25.00%) met the primary end point than t.i.d (10/81, 12.35%) or placebo (9/95, 9.47%) in both FAS and ITT. Adjusted odds ratio (AOR) for b.i.d. vs placebo was 3.26 (95% confidence interval (CI): 1.39-7.67; P = 0.007) and for t.i.d. vs b.i.d. 0.40 (95% CI: 0.17-0.92; P = 0.031). After treatment, the percentage of monthly global responders was higher in the b.i.d. group vs placebo in the first month (64.2% vs 46.6%, adjusted odds ratio = 2.14 95% CI: 1.15; 4.00; P = 0.0173) and first 2 months.
DISCUSSION: Rifamycin SV-MMX 600 mg b.i.d. was more effective than placebo and t.i.d. dosing in the first week of treatment. Two months after treatment, rifamycin SV-MMX 600 mg b.i.d. provided more global symptom relief than placebo.