薬理と治療

Abstract

Objectives To investigate the efficacy and safety of lansoprazole（AG−1749）15 mg and 30mg in Japanese patients with non−erosive reflux disease（NERD）in a phaseIII multi−center, double−blind, placebo−controlled trial, with the primary endpoint being the proportion of the treatment period in which patients remain free of heartburn symptoms, as well as the severity of their heartburn symptoms. Methods Patients were eligible for treatment with antacids（1−week observation period）if they had heartburn symptoms for at least 2 days per week during 3 weeks prior to the start of the study with endoscopic findings of grade M in the modified LA classification system. Patients were randomized to lansoprazole 15 mg（AG 15 group）, lansoprazole 30 mg（AG 30 group）or placebo for an 8−week treatment. Results A total of 248 patients were enrolled in the study and 220 patients were randomized. The median percentage of days without heartburn symptoms during the 8−week treatment period in the AG 15, AG 30 and placebo groups was 77％, 67％, and 54％, respectively, and the median heartburn symptom scores during the 8−week treatment period in these groups were 0.3, 0.4, and 0.6, respectively, with both AG groups found to be more effective than the placebo group. When stratified by response to lansoprazole the cumulative percentage of days without heartburn symptoms in responders in the both AG groups was consistently significantly higher than in the placebo group, while those in non−responders in both AG groups remained low. Conclusions Study results demonstrate that lansoprazole is significantly more effective at 15 mg or 30 mg once daily than placebo in relief of heartburn symptoms in patients with NERD during the 8−week treatment period, especially in responders and that 15 mg oncedaily was considered to be optimal in Japanese patients with NERD. （Jpn Pharmacol Ther 2008；36：655−71）KEY WORDS Lansoprazole, PhaseIII multicenter, Double−blind, Placebo−controlled trial, Heartburn symptoms, NERD, Non−erosive reflux disease