New data being presented at the American College of Gastroenterology (ACG) 2009 Annual Scientific Meeting in San Diego showed that treatment with KAPIDEX™ (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.
GERD, commonly known as acid reflux disease, affects nearly 19 million Americans. GERD is often characterized by frequent and persistent heartburn that occurs two or more days a week despite treatment and diet changes. GERD can affect both men and women, and symptoms are often triggered by certain foods, stress or pressure on the stomach. Up to 70 percent of GERD patients have non-erosive GERD, a term used to describe symptoms suggestive of GERD in patients with no endoscopic evidence of EE.
About KAPIDEX™ (dexlansoprazole) delayed release capsules
KAPIDEX (dexlansoprazole) delayed release capsules is a proton pump inhibitor (PPI), which decreases acid production by turning off many of the acid pumps in the stomach, thus helping to protect the esophagus from acidic reflux so that esophageal inflammation can heal. KAPIDEX combines an enantiomer of lansoprazole with a Dual Delayed Release™ (DDR) formulation designed to provide two separate releases of medication. KAPIDEX, taken once daily, is approved for the healing of all grades of erosive esophagitis (EE) for up to eight weeks, maintaining healing of EE for up to six months, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.
Important Safety Information
KAPIDEX is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity and anaphylaxis have been reported with KAPIDEX use. Symptomatic response with KAPIDEX does not preclude the presence of gastric malignancy. The most commonly reported treatment-emergent adverse reactions (≥2%) include diarrhea (4.8%), abdominal pain (4.0%), nausea (2.9%), upper respiratory tract infection (1.9%), vomiting (1.6%), and flatulence (1.6%). KAPIDEX must not be co-administered with atazanavir because atazanavir systemic concentrations may be substantially decreased. KAPIDEX may interfere with the absorption of drugs for which gastric pH is important for bioavailability (e.g., ampicillin esters, digoxin, iron salts, ketoconazole). Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time. Increases in INR and prothrombin time may lead to abnormal bleeding, which can lead to serious consequences. Concomitant tacrolimus use may increase tacrolimus whole blood concentrations.
Please see the complete prescribing information and visit the KAPIDEX Web site at www.kapidex.com.
Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about these Takeda companies, visit www.tpna.com.
Takeda Pharmaceuticals North America, Inc.