Esomeprazole provides improved acid control vs. omeprazole In patients with symptoms of gastro-oesophageal reflux disease.
BACKGROUND
Esomeprazole (Nexium) is a new proton pump inhibitor for the treatment of acid-related diseases.


METHODS
In this double-blind crossover study, 38 patients with gastro-oesophageal reflux disease (GERD) symptoms were randomized to esomeprazole 40 and 20 mg and omeprazole 20 mg once daily for 5 days. On day 5 of each dosing period, 24-h intragastric pH and pharmacokinetic variables were measured.


RESULTS
Thirty-six patients aged 29-58 (mean 45) years completed the study. Esomeprazole 40 and 20 mg maintained intragastric pH > 4 for (mean) 16.8 and 12.7 h, respectively, vs. 10.5 h for omeprazole 20 mg (P < 0.001 and P < 0. 01). Twenty-four-hour median intragastric pH was significantly higher with esomeprazole 40 mg (4.9) and 20 mg (4.1) than with omeprazole 20 mg (3.6) (P < 0.001 and P < 0.01). Area under the plasma concentration-time curve (AUC) was 80% higher for esomeprazole 20 mg vs. omeprazole, while that for esomeprazole 40 mg was more than five times higher (each P < 0.0001). Interpatient variability in intragastric pH and AUC was less with esomeprazole than with omeprazole. Esomeprazole was well tolerated and there were no safety concerns.


CONCLUSIONS
Esomeprazole provides more effective acid control than omeprazole, with reduced interpatient variability, thereby offering the potential for improved efficacy in acid-related diseases.
Lind
T
T
Department of Surgery, Kärnsjukhuset, Skövde, Sweden. tore.lind@vgregion.se
Rydberg
L
L
Kylebäck
A
A
Jonsson
A
A
Andersson
T
T
Hasselgren
G
G
Holmberg
J
J
Röhss
K
K
D000328:Adult; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D064098:Esomeprazole; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000378:metabolism; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013237:Stereoisomerism
D000897:Anti-Ulcer Agents; D009853:Omeprazole; D064098:Esomeprazole