SAN DIEGO — A novel bile acid sequestrant helped improve heartburn and regurgitation in patients with persistent GERD who continued receiving proton pump inhibitors, according to study results presented at Digestive Disease Week.
Michael F. Vaezi , MD, PhD, of Vanderbilt University Medical Center, said the drug — IW-3718 (Ironwood Pharmaceuticals) — could be a helpful adjunct to PPI therapy.
“Proton pump inhibitors are front-line therapy for [GERD] but not completely effective in some of our patients,” he said in his presentation. “Bile acids, we’ve done work in the past, as well as others, that has shown that it does play a role in the pathogenesis of reflux, such as esophagitis and possibly Barrett’s. ... Could it also be playing a role in persistent reflux?”
Vaezi and colleagues previously found that the drug was effective in treating GERD, but in this study, they explored its impact on specific symptoms.
Researchers included 280 patients with GERD who had to have heartburn or regurgitation for at least 4 days per week for 8 weeks despite ongoing PPI use. After a two-week pretreatment phase, they randomly assigned patients to receive either 500 mg, 1,000 mg or 1,500 mg of IW-3718 or placebo twice daily for 8 weeks in addition to PPIs once a day.
Patients reported the severity and frequency of 10 symptoms associated with GERD at baseline, including heartburn, regurgitation, pain and burping. The main outcome for the study was change in scores at week 8.
Vaezi and colleagues observed that there was a dose-response relationship, with patients who received 1,500 mg of the drug experiencing improvements for all symptoms in both severity and frequency compared with placebo (P .05), except for burping frequency.
“The novel gastric-retentive bile acid sequestrant IW-3718 was efficacious in reducing a spectrum of symptoms in patients with persistent GERD, whether it be symptoms that were assessed by severity or by frequency,” Vaezi concluded, adding that phase 3 studies are in the works. – by Alex Young
Vaezi MF, et al. Abstract 12; Presented at; Digestive Disease Week; May 18-21, 2019; San Diego.
Disclosures: Vaezi reports serving on the medical advisory board for Ironwood Pharmaceuticals. Please see the full meeting disclosure index for all other authors’ relevant financial disclosures.