Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience.
Author(s): Peura DA, Metz DC, Dabholkar AH, Paris MM, Yu P, Atkinson SN
Affiliation(s): Division of Gastroenterology & Hepatology, University of Virginia Health Sciences Center, Charlottesville, VA, USA.
Publication date & source: 2009-09-04, Aliment Pharmacol Ther., [Epub ahead of print]
SUMMARY Background Dexlansoprazole MR is a Dual Delayed Release formulation of dexlansoprazole, an enantiomer of lansoprazole. Aim To assess safety of dexlansoprazole MR in phase 3 clinical trials Methods Data from 4270 patients receiving dexlansoprazole MR 30 mg (n=455), 60 mg (n=2311), or 90 mg (n=1864); lansoprazole 30 mg (n=1363); or placebo (n=896) in 6 randomized controlled trials and a 12-month safety study were pooled. Safety was assessed via adverse events (AEs), vital signs, electrocardiograms, clinical laboratory results, and gastric biopsies. AEs were summarized per 100 patient-months of exposure to account for imbalances in study drug exposure. Results The number of patients with >/=1 treatment-emergent AE per 100 patient-months was higher in placebo (24.49) and lansoprazole (21.06) groups than in any dexlansoprazole MR (15.64-18.75) group. Fewer patients receiving dexlansoprazole MR discontinued therapy due to an AE (P</=0.05 vs placebo). Seven patients died of events considered unrelated to study drug. Mean serum gastrin rose in all groups except placebo; increases were not dose related. No clinically concerning trends were seen in gastric biopsy results. Endocrine cell hyperplasia, dysplasia, and neoplasia were not observed. Conclusion Dexlansoprazole MR 30-90 mg has a safety profile comparable to that of lansoprazole.