Management of heartburn in a large, randomized, community-based study: Comparison of four therapeutic strategies

OBJECTIVE: Our objective was to compare four management strategies for hear tburn: therapy with an H2-receptor antagonist (ranitidine), therapy with a proton pump inhibitor (lansoprazole), crossover from ranitidine to lansopra zole ("step-up" therapy), and crossover from lansoprazole to ranitidine ("s tep-down" therapy). METHODS: This was a controlled, double-blind, multicenter trial comprising 593 adults with heartburn, randomized to one of four groups for 20 wk. Subj ects received either ranitidine 150 mg b.i.d. for 20 wk, or lansoprazole 30 b.i.d. for 8 wk followed by lansoprazole 30 mg once daily for 12 wk ("step -up"), or lansoprazole 30 mg once daily for 8 wk followed by ranitidine 150 mg b.i.d. for 12 wk ("step-down"). Outcome measures were based on self-rep orts in daily diaries of 24-h heartburn severity, measured by maximum dayti me and nighttime severity, and percentage of 24-h heartburn-free days measu red by absence of both daytime and nighttime heartburn. RESULTS:Median heartburn severity was significantly lower (p < 0.05) for la nsoprazole (0.25) than the other groups (0.46 ranitidine, 0.44 "step-up," 0 .35 "step-down"). The lansoprazole group had a significantly higher percent age of 24-h heartburn-free days (median 81.4%, p < 0.01) than other groups (66.6, 66.9, and 73.6%, respectively). In the "step-up" and "step-down" gro ups, heartburn was less severe, and percentages of 24-h heartburn-free days were higher during lansoprazole treatment regardless of treatment sequence . CONCLUSION: Proton pump inhibitor treatment provides more consistent heartb urn relief than an H2-receptor antagonist, or "step-up" or "step-down" ther apy. (C) 2001 by Am. Cell. of Gastroenterology.