New data being presented at the American College of Gastroenterology (ACG) 2009 Annual Scientific Meeting in San Diego showed that treatment with KAPIDEX(TM) (dexlansoprazole) delayed release capsules over a four-week period resulted in a statistically significant greater percentage of nights without heartburn in subjects with non-erosive gastroesophageal reflux disease (GERD), compared to placebo (p<0.001). In addition, secondary measures showed that KAPIDEX improved relief of nighttime heartburn and GERD-related sleep disturbances (p<0.001). KAPIDEX was approved in January 2009 for the once-daily, oral treatment of heartburn associated with symptomatic non-erosive GERD, the healing of erosive esophagitis (EE) and the maintenance of healed EE.
This multicenter, randomized, double-blind, placebo-controlled clinical trial evaluated the effect of KAPIDEX on subjects with nighttime heartburn symptoms. The study enrolled 305 subjects (ages 18 to 66) with non-erosive symptomatic GERD, who reported having moderate-to-severe nighttime heartburn and GERD-related sleep disturbances on at least three of seven nights. Subjects were randomized to receive either KAPIDEX 30 mg or placebo orally every morning for four weeks. Study results showed that treatment with KAPIDEX 30 mg resulted in a greater percentage of nights without heartburn compared to placebo (73% vs. 36%, respectively, p<0.001). During the last seven days of treatment, KAPIDEX 30 mg also provided relief of nighttime heartburn and GERD-related sleep disturbances in a greater percentage of subjects (48% vs. 20%, and 70% vs. 48%, respectively, p<0.001 for both). Relief was defined as six of seven days without nighttime heartburn and no more than one night with mild heartburn, and six of seven days without GERD-related sleep disturbances.
Takeda Pharmaceuticals North America, Inc.