Vaezi MF, Fass R, Vakil N, et al. - Given that refractory gastroesophageal reflux disease (GERD) reduces the quality of life and creates a significant financial burden on the healthcare system, researchers tested the safety and effectiveness of IW-3718, a bile acid sequestrant, as an adjunct to proton pump inhibitor (PPI) therapy. The sample consisted of 280 patients with confirmed GERD. For this multicenter, double-blind, placebo-controlled trial, the patients, stratified by the status of esophagitis, were randomly assigned (1:1:1:1) to groups given placebo or IW-3718 (500, 1,000, or 1,500 mg) twice daily, with ongoing label-dose PPI. In weekly heartburn severity scores, mean changes from baseline to week 8 were decreases of 46.0% in the placebo group, 49.0% in the 500 mg group, 55.1% in the 1,000 mg group, and 58.0% in the 1,500 mg IW-3718 groups. Adding 1500-mg IW-3718 to label-dose PPIs significantly lessened heartburn symptoms vs adding placebo in a randomized trial of patients with refractory GERD. Symptoms of regurgitation reduced as well. IW-3718 was tolerated well. Constipation was the most common adverse event. There were no serious adverse events related to the drug.