Randomized study of lafutidine vs lansoprazole in patients with mild gastroesophageal reflux disease

AIM: To compare the clinical efficacy of the secondgeneration H2 RA lafutidine with that of lansoprazole in Japanese patients with mild gastroesophageal reflux disease(GERD). METHODS: Patients with symptoms of GERD and a diagnosis of grade A reflux esophagitis(according to the Los Angeles classification) were randomized to receive lafutidine(10 mg, twice daily) or lansoprazole(30 mg, once daily) for an initial 8 wk, followed by maintenance treatment comprising half-doses of the assigned drug for 24 wk. The primary endpoint was the frequency and severity of heartburn during initial and maintenance treatment. The secondary endpoints were the sum score of questions 2 and 3 in the Gastrointestinal Symptom Rating Scale(GSRS), and the satisfaction score.RESULTS: Between April 2012 and March 2013, a total of 53 patients were enrolled, of whom 24 and 29 received lafutidine and lansoprazole, respectively. After 8 wk, the frequency and severity of heartburn was significantly reduced in both groups. However, lafutidine was significantly inferior to lansoprazole with regard to the severity of heartburn during initial and maintenance treatment(P = 0.016). The sum score of questions 2 and 3 in the GSRS, and satisfaction scores were also significantly worse in the lafutidine group than the lansoprazole group(P = 0.0068 and P = 0.0048, respectively).CONCLUSION: The clinical efficacy of lafutidine was inferior to that of lansoprazole, even in Japanese patients with mild GERD.

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.