Rabeprazole improves and maintains overall well being in gastroesophageal reflux disease (GERD) over 5 years

Abstract

Purpose: To compare the impact on overall physical well being of rabepmzole 20 rag, rabeprazole 10 mg, and placebo over 5 years of mainter~ance therapy in GERD patients. Methods: 497 patients, previously diagnosed with erosive/ulcerative GERD healed in an acute efficacy trial, entered a multicenter, double-blind, placebo-controlled, parallel-arm, 1year maintenance study. All patients completing 1 year without GERD relapse were eligible to participate for 4 more years in an extension phase. Efficacy variables of the combined 5 years (260 weeks) of study included: overall physical well-being score (scale, 0 = very good; 4 = very poor), relapse of seventy/frequency of daytime and nighttime heartburn, and antacid use. Results: At endpoint (260 weeks), both rabeprazole groups had significantly higher ratings in overall well being versus placebo (p 2; p-<0.008). Rabeprazole 20 mg also produced a significantly lower relapse rate than rabeprazole 10 mg for weeks 4-65 (p~0.038). These results in overall well being corresponded with significantly lower relapse rates with rabeprazole versus placebo in heartburn frequency and severity seen over 5 years (p-<0.02). Mean daily antacid dose consumed by the rabeprazole 20 mg group (0.17) was less than in the rabeprazole 10 mg (0.24) or placebo groups (0.24) at endpoint. For weeks 4-104 and week 143, there were significant differences in change in daily antacid use from baseline favoring both rabeprazole groups versus the placebo group (p-<0.05). Conclusions: 5-year maintenance therapy with rabeprazole improves overall well being compared with placebo. Research supported by Eisai Inc., Teaneck, NJ and Janssen Pharmaceutica Inc., Titusville, NJ.