Journal
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
Volume 30, Issue 10, Pages 1010-1021Publisher
WILEY
DOI: 10.1111/j.1365-2036.2009.04137.x
Keywords
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Funding
- Takeda Global Research & Development Center, Inc., Deerfield, IL, USA
- Takeda North America, Inc.
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P>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 six randomized controlled trials and a 12-month safety study were pooled. Safety was assessed via adverse events, vital signs, electrocardiograms, clinical laboratory results and gastric biopsies. Adverse events 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 adverse event 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 because of an adverse event (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.
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