Proton pump inhibitor step-down therapy for GERD: a multi-center study in Japan

Abstract

Aim: To investigate the predictors of success in step-down of proton pump inhibitor and to assess the quality of life (QOL).

Methods: Patients who had heartburn twice a week or more were treated with 20 mg omeprazole (OPZ) once daily for 8 wk as an initial therapy (study 1). Patients whose heartburn decreased to once a week or less at the end of the initial therapy were enrolled in study 2 and treated with 10 mg OPZ as maintenance therapy for an additional 6 mo (study 2). QOL was investigated using the gastrointestinal symptom rating scale (GSRS) before initial therapy, after both 4 and 8 wk of initial therapy, and at 1, 2, 3, and 6 mo after starting maintenance therapy.

Results: In study 1, 108 patients were analyzed. Their characteristics were as follows; median age: 63 (range: 20-88) years, sex: 46 women and 62 men. The success rate of the initial therapy was 76%. In the patients with successful initial therapy, abdominal pain, indigestion and reflux GSRS scores were improved. In study 2, 83 patients were analyzed. Seventy of 83 patients completed the study 2 protocol. In the per-protocol analysis, 80% of 70 patients were successful for step-down. On multivariate analysis of baseline demographic data and clinical information, no previous treatment for gastroesophageal reflux disease (GERD) [odds ratio (OR) 0.255, 95% CI: 0.06-0.98] and a lower indigestion score in GSRS at the beginning of step-down therapy (OR 0.214, 95% CI: 0.06-0.73) were found to be the predictors of successful step-down therapy. The improved GSRS scores by initial therapy were maintained through the step-down therapy.

Conclusion: OPZ was effective for most GERD patients. However, those who have had previous treatment for GERD and experience dyspepsia before step-down require particular monitoring for relapse.

Keywords: Gastroesophageal reflux disease; Gastrointestinal symptom rating scale; Omeprazole; Proton pump inhibitor; Step-down therapy.

Figure 1

Overview of the study design. QOL: Quality of life; PPI: Proton pump inhibitor.

Figure 2

Gastrointestinal Symptom Rating Scale scores during the initial treatment (study 1).

Figure 3

Proportion of subjects without recurrent gastroesophageal reflux disease symptoms after proton pump inhibitor step-down (Study 2 per-protocol population: n = 70).

Figure 4

Gastrointestinal Symptom Rating Scale scores during maintenance treatment (study 2).