Clinical characteristics and effectiveness of lansoprazole in Japanese patients with gastroesophageal reflux disease and dyspepsia

Abstract

Patients with gastroesophageal reflux disease (GERD) frequently have symptoms of dyspepsia in addition to reflux symptoms. Treatment options for dyspepsia are not standardized. The aim of this study was to clarify the therapeutic effect of lansoprazole on dyspepsia in Japanese patients with GERD. GERD patients with dyspepsia were enrolled and treated with lansoprazole 15 or 30mg once daily for 4weeks. Reflux and dyspeptic symptoms were assessed by questionnaires before treatment, and 2 and 4weeks after the start of lansoprazole treatment. In the effectiveness analysis set (n=12,653), heartburn was reported by 91.6% of patients at study enrollment. Postprandial fullness was the most frequently reported dyspepsia symptom at the start of the study, reported by 79.0% of enrolled patients. After 4weeks of lansoprazole treatment, heartburn symptoms were improved in 75.7% of patients and symptoms of postprandial fullness were improved in 68.7% of patients. The therapeutic effect of low and high doses of lansoprazole on dyspepsia, as well as on reflux symptoms, was approximately 10% higher in patients with endoscopy-confirmed erosive esophagitis (60.1-82.2%), than in patients with non-erosive reflux diseases (53.0-73.3%). Lansoprazole was well tolerated. In this large-scale clinical study, lansoprazole effectively relieved dyspepsia in addition to reflux symptoms in patients with GERD.