Data Presented at DDW About Rebound Symptoms in Healed Erosive Esophagitis Patients After Completion of Treatment with DEXILANT(TM) (dexlansoprazole)
Product trade name for dexlansoprazole was recently changed from KAPIDEX(TM) (dexlansoprazole) to DEXILANT
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(TM) (DDR)
formulation. Takeda recently announced that the product trade name
for dexlansoprazole in the United States would be changed to
DEXILANT from KAPIDEX(TM) (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(TM) (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(TM) (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.
CONTACT: Elissa J. Johnsen, Takeda Pharmaceuticals North
America, Inc.,
+1-224-554-3185, ejohnsen@tpna.com; or Carrie Rose,
Ketchum, +1-646-935-3938,
carrie.rose@ketchum.com
Web Site: http://www.tpna.com/
Posted: May 2010
