Gastroenterology: Bile acid chelating agent IW-3718 can reduce heartburns in patients with refractive gastroesophageal reflux

Background and objectiverefractory gastroesophageal reflux disease (GERD) can significantly reduce the quality of life of patients and place a huge financial burden on the health care systemStudies have shown that about 30% of GERD patients treated with proton pump inhibitors (PPI) still have symptoms of gastroesophageal refluxThe purpose of this study is to conduct a clinical trial to assess the efficacy and safety of IW-3718( a bile acid chelating agent) as an auxiliary agent for PPI therapymethodsresearchers conducted multicenter, double-blind, placebo-controlled trials of 280 patients diagnosed with GERD between March 2016 and April 2017Patients who have been stratified by esophagitis were randomly assigned (1:1:1:1) to a group receiving placebo or IW-3718 (500, 1000, or 1500 mg), twice a day, and given a marked dose of PPI therapyThe main observation endpoint was a change in the patient's weekly heartburn severity scoreresultsthe average change in weekly heartburn severity score from baseline to week 8 was: 46.0% reduction in the placebo group, 49.0% reduction in the IW-3718500 mg group, 55.1% decrease in the 1000 mg group, and 58.0% decrease in the 1500 mg group (dose response P.02)The difference in treatment between 1500 mg IW-3718 and the placebo group was 11.9% (P-04)Compared to the placebo group, the average change in the weekly reflux frequency score from baseline to 8 weeks decreased by 17.5% (95% confidence interval, 31.4% to 3.6%)The most common adverse event was constipation (8.1% in patients receiving IW-3718 and 7.1% in patients receiving a placebo)Conclusion
adding 1500 mg IW-3718 to PPI therapy compared to a placebo in a randomized trial in this patient with refractive GERD, significantly reduced heartburn symptoms Reflux symptoms also decreased IW-3718 is well tolerated