Navigation Links
Data Presented at DDW About Rebound Symptoms in Healed Erosive Esophagitis Patients After Completion of Treatment with DEXILANT(TM) (dexlansoprazole)
Date:5/5/2010

NEW ORLEANS, May 5 /PRNewswire/ --

What:

Data results from a recent retrospective analysis of DEXILANT delayed release capsules and lansoprazole were presented at Digestive Disease Week (DDW) 2010 in New Orleans. DEXILANT is a proton pump inhibitor (PPI) with a Dual Delayed Release™ (DDR) formulation. Takeda recently announced that the product trade name for dexlansoprazole in the United States would be changed to DEXILANT from KAPIDEX™ (dexlansoprazole).

The medical community has been investigating whether patients who discontinue PPI therapy experience rebound gastric hypersecretion, and whether acid rebound is clinically relevant. Rebound acid hypersecretion is defined as an increase in gastric acid secretion above pretreatment levels following discontinuation of antisecretory therapy.

A new retrospective analysis of data from pivotal erosive esophagitis (EE) healing and maintenance of healed EE trials of H pylori-negative patients healed at Week 4 or 8:

  • Compared baseline and follow-up serum gastrin levels, a surrogate of acid hypersecretion, and 24-hour heartburn severity prior to enrolling patients in the EE healing trials with DEXILANT and lansoprazole, and then again after patients received placebo in the maintenance of healed EE trials.
  • Mean serum gastrin values at month 1 (N=130) and month 3 (N=52) after randomization to placebo in the maintenance trials were essentially unchanged versus baseline prior to the healing EE trials (N=216). Findings suggested that serum gastrin levels were normalized within 1 month of discontinuing PPIs and remained flat.
  • Mean heartburn severity at month 1 (N=222) after randomization to placebo was significantly lower than baseline despite the absence of PPI maintenance treatment. In those with month 2 data, mean heartburn severity at month 2 was significantly lower than baseline. Findings suggested that withdrawal of DEXILANT or lansoprazole did not cause symptom rebound within 2 months of discontinuing therapy.

This analysis is entitled Lack of Acid and Symptom Rebound After Withdrawal of 4 to 8 Weeks of Dexlansoprazole MR or Lansoprazole Therapy.

Who:

  • Gilles Delecoeuillerie, M.D., Executive Medical Director, Medical & Scientific Affairs, Gastroenterology and Internal Medicine, Takeda

When:

  • ABSTRACT #W1104 will be announced via poster presentation on May 5, 2010 at the Ernest N. Morial Convention Center, Hall F

To arrange an interview, please contact Carrie Rose at 646-935-3938.

About DEXILANT™ (dexlansoprazole) 30 mg and 60 mg delayed release capsules

DEXILANT 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. DEXILANT combines an enantiomer of lansoprazole with a Dual Delayed Release™ (DDR) formulation designed to provide two separate releases of medication. DEXILANT, 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

DEXILANT is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity and anaphylaxis have been reported with DEXILANT use. Symptomatic response with DEXILANT does not preclude the presence of gastric malignancy.

The most commonly reported treatment-emergent adverse reactions include diarrhea (4.8%), abdominal pain (4.0%), nausea (2.9%), upper respiratory tract infection (1.9%), vomiting (1.6%), and flatulence (1.6%). DEXILANT must not be co-administered with atazanavir because atazanavir systemic concentrations may be substantially decreased.

DEXILANT 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 and even death. Concomitant tacrolimus use may increase tacrolimus whole blood concentrations.

Please click here for full prescribing information and visit the DEXILANT Web site at www.DEXILANT.com.

About Digestive Disease Week (DDW)

DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 1 – 5, 2010, New Orleans. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

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. To learn more about these Takeda companies, visit www.tpna.com.


'/>"/>
SOURCE Takeda Pharmaceuticals North America, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Data From LigoCytes Clinical Studies of Norovirus VLP Vaccine Presented at 13th Annual Conference on Vaccine Research
2. 12 Month Follow-Up Data for Isotope-Free Breast IORT Presented at ASBS Meeting
3. iFuse Implant System(TM) to be Presented at Leading Minimally Invasive Spine Surgical Meetings
4. Kristalose(R) Clinical Data to Be Presented at Digestive Disease Week(R) Meeting
5. Positive Long Term Data Presented at ACC 2010 Demonstrate Sustained Safety and Efficacy Advantages of the Cypher(R) Sirolimus Drug-Eluting Stent Over the Endeavor(R) Zotarolimus-Eluting Stent
6. Data Presented at ACC/i2 Summit Demonstrate Impressive Long Term Clinical Outcomes in Real World Patients Treated with OrbusNeichs Genous(TM) Bio-engineered R stent(TM)
7. New PLATO Sub-Analysis of CABG Patients Presented at ACC
8. Key Caldolor(R) Orthopedic Data to Be Presented at American Academy of Orthopaedic Surgeons Annual Meeting
9. STELARA(TM) and REMICADE(R) Data in Treatment of Plaque Psoriasis to be Presented at American Academy of Dermatology (AAD) Meeting
10. Clinical Data Presented at Asia PCR/Sing LIVE Demonstrate Benefits of OrbusNeichs Genous(TM) Bio-engineered R stent(TM) in Challenging Patient Subsets
11. Data From Three Clinical Studies of bioTheranostics Breast Cancer Molecular Test Presented at CTRC-AACR San Antonio Breast Cancer Symposium
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... YORK , April 28, 2016  While ... notably complement the company,s valve repair and stent ... move also places Abbott more firmly into patient ... of the fastest growing device areas, with double-digit ... its recent report,  Advanced Remote Patient Monitoring ...
(Date:4/28/2016)... NEW YORK , April 28, 2016  The ... reached 275 million dollars, according to Kalorama Information and ... includes typing, immunoassays and nucleic acid testing.  The healthcare ... had made progress in developing blood collection stations and ... was made in Kalorama Information,s report, Blood ...
(Date:4/28/2016)... JERUSALEM , April 28, 2016 ... ), a clinical-stage pharmaceutical company focused on the development of ... participate in the upcoming PIONEERS 2016 conference, presented by ... 5, 2016 in New York . ... overview at the conference. Presentation Details:   ...
Breaking Medicine Technology:
(Date:4/30/2016)... ... 2016 , ... Saturday, April 30, marks World Veterinary Day, ... health. The World Veterinary Association (WVA) and the World Organization for Animal Health ... with a One Health focus, which emphasizes how veterinarians pursue continuing education opportunities ...
(Date:4/29/2016)... ... April 30, 2016 , ... World Patent Marketing ... Up Springboard, an automotive invention that improves the storage features of a pick ... billion," says Scott Cooper, CEO and Creative Director of World Patent Marketing. "Over ...
(Date:4/29/2016)... ... April 29, 2016 , ... ... , announces the addition Onnit brand Alpha BRAIN and New Mood Daily-Stress Formula ... brain and mood optimization products to the store is just one more way ...
(Date:4/29/2016)... ... April 29, 2016 , ... ... more flexibility in repaying their loans, more information about their loan terms and ... total outstanding student loan debt, including federal and private loans, has reached $1.3 ...
(Date:4/29/2016)... ... April 29, 2016 , ... The ... the $30,000 Perlman Grand Prize of the 2016 Wharton Business Plan Competition ... Michelson People’s Choice Award, and the Committee Award for Most ‘Wow Factor,’ making ...
Breaking Medicine News(10 mins):