Gastric Biopsy Results From Patients Treated With Dexlansoprazole MR, a Proton Pump Inhibitor with a Dual Delayed Release Formulation: 13
Abstract
Purpose: Dexlansoprazole MR (DEX), an enantiomer of lansoprazole, is a PPI that employs novel Dual Delayed Release technology to extend the duration of acid suppression. This analysis was performed to identify potential gastric effects of DEX. Methods: Gastric biopsies were obtained at baseline and final visit from patients with symptomatic GERD or erosive esophagitis who participated in 1 of several healing, maintenance, or safety studies. Patients were treated for 6 months with DEX or placebo in the maintenance studies and for 12 months with DEX in the safety study. Mucosal biopsies were taken from the gastric antrum and fundus/body (2 from each location). All biopsies were evaluated by expert gastrointestinal subspecialty pathologists at the Cleveland Clinic for H. pylori, active and chronic gastritis, intestinal metaplasia (IM), endocrine cell hyperplasia, reactive gastropathy, and other pathologies. The diagnoses were summarized by treatment group and compared with Fisher's exact test. Results: Final visit biopsies adequate for diagnosis were available for 446 patients receiving DEX 30, 60 or 90 mg and 140 patients receiving placebo in the maintenance trials and for 411 DEX 60 or 90 mg recipients in the safety trial. At baseline, up to half of patients had abnormal biopsy results (antral or fundic), primarily chronic gastritis or reactive gastropathy. At final visit, most patients with normal histology at baseline remained normal (DEX, 78%; placebo, 77%). Chronic…
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