Esomeprazole 40 mg administered intravenously has similar safety and efficacy profiles to the oral formulation in patients with erosive esophagitis
Date
2004
Authors
Schneider, H.
Van Rensburg, C.
Schmidt, S.
Aboo, N.
Makela, H.
Naucler, E.
Hallerback, B.
Svedberg, L-E.
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Abstract
Background/Aims: An intravenous formulation of esomeprazole has been developed for use in patients where oral administration is not appropriate. This study evaluated safety after 1 and 4 weeks, and efficacy after 4 weeks' esomeprazole 40 mg once daily treatment, administered via an intravenous injection, intravenous infusion or orally, in patients with erosive esophagitis. Methods: In this double-blind, multi-centre study, patients with endoscopically confirmed erosive esophagitis (Los Angeles grade A-D) were randomized to receive 1 week's treatment of esomeprazole 40 mg once daily, via a 3-min injection, a 30-min infusion or orally, followed by 3 weeks of open treatment with oral esomeprazole 40 mg once daily. Safety variables were evaluated following 1 and 4 weeks' esomeprazole treatment. Healing rates at 4 weeks were estimated. Results: Intravenous and oral esomeprazole were equally well tolerated during the first week, and after 4 weeks' treatment. The 3 treatment groups showed similar levels of healing following 4 weeks' treatment with esomeprazole (injection + oral: 79.7%; infusion + oral: 80.2%; oral alone: 82.6%). Conclusions: Esomeprazole 40 mg administered via an intravenous injection, intravenous infusion or orally administered for 1 week, followed by 3 weeks of oral dosing, is well tolerated and provides effective healing of erosive esophagitis. Copyright © 2004 S. Karger AG.
Description
Keywords
esomeprazole, abdominal pain, adult, aged, article, cerebrovascular disease, clinical trial, constipation, controlled clinical trial, controlled study, diarrhea, dizziness, double blind procedure, drug effect, drug efficacy, drug eruption, drug formulation, drug safety, drug tolerability, dysentery, endoscope, female, flatulence, gastroenteritis, headache, healing, heart infarction, human, major clinical study, male, multicenter study, nausea, priority journal, pruritus, randomized controlled trial, reflux esophagitis, side effect, thorax pain, vertigo, visual disorder, xerostomia, Administration, Oral, Adult, Aged, Anti-Ulcer Agents, Dose-Response Relationship, Drug, Esophagitis, Female, Humans, Infusions, Intravenous, Injections, Intravenous, Male, Middle Aged, Omeprazole, Treatment Outcome
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