Navigation Links
New Study Results Analyzed the Use of KAPIDEX(TM) (dexlansoprazole) for Nighttime Heartburn in Adults with Non-Erosive GERD
Date:10/26/2009

SAN DIEGO, Oct. 26 /PRNewswire/ -- 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.

About GERD

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(TM) (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(TM) (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 (greater than or equal to 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.

SOURCE Takeda Pharmaceuticals North America, Inc.


'/>"/>
SOURCE Takeda Pharmaceuticals North America, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. New Study Confirms VASER Lipo Results Are Superior to Standard Liposuction
2. Biomoda Enters Final Stage of Patient Testing for Phase II Lung Cancer Clinical Study
3. Delcath Systems, Inc. Completes Phase III Study Enrollment
4. AlphaDetail Tracking Study Enhancements: The Advantage of Integration and Speed
5. Oramed Pharmaceuticals was Chosen to Present Results of a GLP-1 Analog Oral Administration Study at the Diabetes Technology Societys Ninth Annual Meeting (November 5-7, 2009; San Francisco, CA)
6. Novavax Launches Pivotal Clinical Study of Novel 2009 H1N1 VLP Flu Vaccine in Mexico
7. comScore Study Finds the Internet a Key Component in Consumer Research on Prescriptions and Health Conditions
8. Data from Jazz Pharmaceuticals First Phase III Study of Sodium Oxybate in Patients With Fibromyalgia to be Presented at Upcoming Conferences
9. CVS Caremark Undertakes Multi-Year Study to Improve Patient Medication Adherence
10. ProUroCare Medical Completes Multiple Site Clinical Study for Imaging Prostate Abnormalities
11. DATATRAK Signs 6 Year Study with New Device Client
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... Research and Markets has announced the ... Tests" report to their offering. ... The World Market for Companion Diagnostics covers the ... analysis in the report includes the following: ... Kits) by Region (N. America, EU, ROW), 2015-2020 , ...
(Date:6/24/2016)... Belgium , June 24, 2016 /PRNewswire/ ... announced the appointment of Dr. Edward Futcher ... a Non-Executive Director, effective June 23, 2016.Dr. Futcher ... and Nominations and Governance Committees.  As a non-executive ... provide independent expertise and strategic counsel to VolitionRx ...
(Date:6/23/2016)... , June 23, 2016 Research ... Devices Global Market - Forecast to 2022" report to ... the treatment method for the patients with kidney failure, it ... excess fluid from the patient,s blood and thus the treatment ... potassium and chloride in balance. Increasing number ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... 27, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating to Best ... individuals in the United States and Canada wear eyeglasses. Once considered to be a ... and make a fashion statement. Even celebrities use glasses as a way of creating ...
(Date:6/26/2016)... ... ... Brent Kasmer, a legally blind and certified personal trainer is helping to develop a weight ... app plans to fix the two major problems leading the fitness industry today:, ... program , They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture ... said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package ... Final Cut Pro X . Simply select a ProHand generator and drag it ...
(Date:6/25/2016)... Montreal, Canada (PRWEB) , ... June 25, 2016 , ... ... the pursuit of success. In terms of the latter, setting the bar too high ... low, risk more than just slow progress toward their goal. , Research from ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association ... it will receive two significant new grants to support its work to advance ... 25th anniversary by recognizing patients, medical professionals and scientists for their work in ...
Breaking Medicine News(10 mins):