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

AIM：To investigate the predictors of success in stepdown 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 in-vestigated 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 stepdown.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 stepdown require particular monitoring for relapse.