Bile acid sequestrant relieves refractory GERD symptoms
Recently published study results showed that the bile acid sequestrant IW-3718 reduced heartburn and regurgitation symptoms in patients with refractory GERD.
Further, the 1,500 mg twice-daily dose of IW-3718 (Ironwood Pharmaceuticals) showed the best results vs. placebo than the 500 mg and 1,000 mg doses.
“The study showed that heartburn symptoms were significantly reduced in the group receiving 1,500 mg twice daily, compared to the placebo group,” Michael F. Vaezi, MD, PhD, of Vanderbilt University Medical Center, told Healio Gastroenterology and Liver Disease. “Regurgitation symptoms also decreased. The drug was well tolerated. There were no drug-related serious adverse events. These data are encouraging results suggesting that IW-3718 may provide a therapeutic option for refractory GERD patients.”
Vaezi and colleagues conducted a 52-center randomized, double-blind placebo-controlled study of 280 patients with refractory GERD who continued experiencing reflux despite once daily PPI therapy. Patients received placebo or 500 mg, 1,000 mg or 1,500 mg twice daily IW-3178.
Percent change from baseline to week 8 in weekly heartburn severity score was the primary end point. Researchers also assessed percent change form baseline to week 8 in weekly regurgitation frequency score.
From baseline to week 8, the mean changes in the weekly heartburn severity scores were 46% reductions in the placebo group, 49% in 500 mg group, 55.1% in the 1,000 mg group and 58% in the 1,500 mg group. The treatment difference between the 1,500 mg group and the placebo group was 11.9% (P = .04).
The mean change in weekly regurgitation frequency score from baseline to week 8 was in the 1,500 mg group vs. the placebo group was a reduction of 17.5%.
Constipation was the most common adverse event, occurring in 8.1% of patients who received IW-3718 and 7.1% of those who received placebo. No drug-related serious adverse events were observed.
“This study has the potential to change our clinical approach in those with refractory GERD whose symptoms may be from continued retrograde reflux of gastroduodenal contents including bile acids,” Vaezi said. “In the era of escalating therapy with proton pump inhibitors whose actions are solely in reducing gastric acidity, a novel approach targeting other injurious factors in GERD, such as bile acids, may be what we need to better care for patients refractory GERD.” – by Monica Jaramillo
Disclosure: This study was funded by Ironwood Pharmaceuticals. Vaezi reports serving on medical advisory boards as a paid consultant for Ironwood Pharmaceuticals.