Full text loading...
薬理と治療
- Author: 藤本一眞1
Abstract
Background and Aim With the approval of Pariet_10 mg tablet for the maintenance treatmentof recurring/relapsing reflux esophagitis(RE)in July, 2003, the safety and efficacy ofthe tablet in long−term treatment were evaluated by the post−marketing survaillance.Methods Pariet_10 mg tablet once daily was administrated in patients with recurring/relapsing RE, whose RE had been healed endoscopically before survey. The duration ofadministration was between 6 and 24 months. The survey was implemented by the centralregistration system between Oct. 1, 2003 and Sep.20, 2006.Results 1443 subjects for safety and 898 subjects for efficacy were analyzed. Adverse reactionswere reported in 92 cases(6.38%, 1017 events). Based on patient background, significantdifferences were observed in 6 items i. e. complication of RE, pretreatment endoscopicfinding, history of RE treatment, history of RE, history of allergy and concomitant drug.Among 621 cases with endoscopic assessment, non−recurrent rates were 89.9% after52 weeks and 74.7% after 104 weeks in Kaplan−Meier method. In non−recurrent rate, significantdifferences were observed in two items(complication of RE and pretreatment endoscopicfinding)after 52 weeks and in 4 items(complication of RE, pretreatment endoscopicfindings, posttreatment endoscopic findings and history of GI tract surgery)after 104 weeks.Conclusion Pariet_10 mg tablet showed high tolerability for maintenance treatment ofrecurring/replacing RE and proved excellent preventive effect of RE. Incidence of adversereaction in two−year treatment was 6.38%. Non−recurrent rates were 89.9% and 74.4%after 52 and 104 weeks respectively.(Jpn Pharmacol Ther 2009;37:829−45)KEY WORDS Rabeprazole, Proton pump inhibitor, Maintenance treatment for reflux esophagitis,Long−term treatment, Special post−marketing surveillance
Data & Media loading...