• Yoshikazu Kinoshita, Mototsugu Kato, Mitsuhiro Fujishiro, Hironori Masuyama, Ryo Nakata, Hisanori Abe, Shinji Kumagai, Yasushi Fukushima, Yoshiumi Okubo, Seiichiro Hojo, and Motoyasu Kusano.
• Department of Internal Medicine II, Faculty of Medicine, Shimane University, 89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan. kinosita@med.shimane-u.ac.jp.
• J. Gastroenterol. 2018 Jul 1; 53 (7): 834-844.

BackgroundRabeprazole at 10 or 20 mg twice daily (b.i.d.) has been reported to be highly effective in the treatment of proton pump inhibitor (PPI)-resistant reflux esophagitis (RE) that is refractory to the standard once-daily PPI regimen. We evaluated the efficacy and safety of rabeprazole maintenance therapy at 10 mg once daily (q.d.) or b.i.d. for longer than 8 weeks.MethodsPatients with RE refractory to standard PPI regimens for at least 8 weeks were enrolled. They were treated with rabeprazole at 10 or 20 mg b.i.d. for 8 weeks during the open-label treatment period. After endoscopic examination, those with confirmed healing entered the subsequent double-blind maintenance therapy. During this period, the subjects were randomized to receive rabeprazole 10 mg q.d. (control) or 10 mg b.i.d. The primary endpoint was the endoscopic no-recurrence rate at Week 52.ResultsIn total, 517 subjects entered the treatment, and 359 subjects continued on maintenance therapy. The full analysis set for central assessment included 343 subjects. The no-recurrence rate at Week 52 was significantly higher in the b.i.d. group (73.9%; p < 0.001, χ2 test) than in the q.d. group (44.8%). In particular, the b.i.d. regimen was more effective in all subgroups with Los Angeles Classification Grade B to D at treatment entry.ConclusionsIn the maintenance treatment of PPI-resistant RE, rabeprazole at 10 mg b.i.d. exerted a stronger recurrence-preventing effect than 10 mg q.d. over 52 weeks. No particular safety issues were noted during long-term administration. ClinicalTrials.gov number: NCT02135107.

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