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

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.

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.

Source: Takeda Pharmaceuticals North America, Inc

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