薬理と治療

Abstract

Objectives To investigate the pharmacodynamic efficacy of lansoprazole（AG−1749）15 mg and 30 mg in controlling intraesophageal pH, as well as reflux−associated symptoms such as heartburn in Japanese patients with grade M non−erosive reflux disease in a multi−center, randomized, double−blind trial, with the primary endpoint being the ％ of time intraesophageal pH below 4.0 and the secondary endpoint being the percentage of days in which they remain free of heartburn, as well as the severity of their heartburn, before and after treatment with lansoprazole. Methods Patients were randomized to AG 15 and AG 30 group after 1−week observation period with antacids to confirm to have heartburn for at least 2 days per week, to have endoscopic findings of grade M, and to be 4％ or more in the ％ of time intraesophageal pH below 4.0. Results A total of 10 patients each judged to be assessable in the AG 15 and AG 30 group were included for analyses, although a total of 39 patients were enrolled in the stxudy. The ％ of time intraesophageal pH below 4.0 was 16±12.9％ nd 10±4.0％ in the AG 15 and AG groups, respectively, before treatment, while those of the treatment periods of 5 to 8 weeks was 2±1.4％ and 1±2.7％ in the AG 15 and AG 30 groups, respectively. This accounted for a statistically ignificant difference of−15±12.5％ in the AG 15 group and −8±4.0％ in the AG 30 group between before and after eatment, while there was no significant difference between the treatment arms. The percentage of days in the treatment period in which patients remained free of heart burn was 59％ and 65％ in the AG 15 and AG 30 group, respectively. The median severity of heartburn symptoms was similar and not significantly different between the AG 15 group and AG 30 roup at 0.5, and 0.5, respectively. Conclusions Lansoprazole was shown to be efficacious in controlling intraesophageal pH, as well as acid reflux−associated symptoms such as heartburn, thus offering a clear clinical benefit to NERD patients.（Jpn Pharmacol Ther 2008；36：641−54）KEY WORDS Lansoprazole, Pharmacodynamic efficacy, Multi−center randomized ouble blind trial, Non−erosive reflux disease, NERD, 24−hour intraesophageal pH monitoring, Heartburn