Comparison of the effects of intravenously and orally administered esomeprazole on acid output in patients with symptoms of gastro-oesophageal reflux disease.
BACKGROUND
Intravenous esomeprazole may be beneficial for patients who cannot take oral medications.


OBJECTIVE
To compare intravenous esomeprazole with oral esomeprazole for effects on maximal acid output during pentagastrin stimulation in patients with gastro-oesophageal reflux disease symptoms.


METHODS
In four separate open-label, randomized, two-way crossover studies, adult patients were administered esomeprazole 20 or 40 mg once daily either orally or intravenously (by 15-min infusion or 3-min injection) for 10 days and switched to the other formulation with no washout period. Basal acid output and maximal acid output were measured on days 11, 13 and 21.


RESULTS
In the four studies (total of 183 patients), least-squares mean maximal acid output ranged from 3.0 to 4.1 mmol/h after intravenous esomeprazole 40 or 20 mg and from 2.2 to 3.3 mmol/h after oral esomeprazole 20 or 40 mg. Differences between formulations were small and not statistically significant but did not meet the prospectively defined criterion for non-inferiority of the intravenous formulation. Median basal acid output values ranged from 0.04 to 0.27 mmol/h after intravenous administration and from 0.05 to 0.25 mmol/h after oral esomeprazole.


CONCLUSIONS
Intravenous esomeprazole is an acceptable alternative to the oral formulation for treatment of up to 10 days of duration.
Metz
D C
DC
Division of Gastroenterology, University of Pennsylvania, Philadelphia, PA 19104, USA. david.metz@uphs.upenn.edu
Miner
P B
PB
Heuman
D M
DM
Chen
Y
Y
Sostek
M
M
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D004791:Enzyme Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D064098:Esomeprazole / Q000008:administration & dosage* / Q000009:adverse effects; D004942:Esophagitis, Peptic / Q000150:complications / Q000188:drug therapy; D005260:Female; D005744:Gastric Acid / Q000502:physiology*; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors; D012737:Sex Factors; D016896:Treatment Outcome
D004791:Enzyme Inhibitors; D054328:Proton Pump Inhibitors; D064098:Esomeprazole