Authors: Lind¹; Rydberg¹; Kylebäck¹; Jonsson¹; Andersson²; Hasselgren³; Holmberg³; Röhss³

Source: Alimentary Pharmacology & Therapeutics, Volume 14, Number 7, July 2000 , pp. 861-867(7)

Publisher: Wiley-Blackwell

Abstract:

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.

Document Type: Research article

DOI: http://dx.doi.org/10.1046/j.1365-2036.2000.00813.x

Affiliations: 1: Department of Surgery, Kärnsjukhuset, Skövde, Sweden, 2: AstraZeneca LP, Wayne, PA, USA, 3: AstraZeneca R&D, Mölndal, Sweden

Publication date: 2000-07-01

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