Esomeprazole 40 mg administered intravenously has similar safety and efficacy profiles to the oral formulation in patients with erosive esophagitis.
OBJECTIVE
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.
Schneider
Herbert
H
Milpark Hospital, Guild Road, Parktown West, Johannesburg, South Africa. gidoc@global.co.za
Van Rensburg
Christoffel
C
Schmidt
Stephen
S
Aboo
Nazimuddin
N
Makela
Heli
H
Nauclér
Emma
E
Hallerback
Bengt
B
Svedberg
Lars-Erik
LE
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D064098:Esomeprazole / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D004941:Esophagitis / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D064098:Esomeprazole