High- versus standard-dose ranitidine for control of heartburn in poorly responsive acid reflux disease: A prospective, controlled trial

Objective: H-2-receptor antagonists are commonly used as initial therapy in patients with gastroesophageal reflux disease (GERD) and are frequently co ntinued at the same or higher doses when symptoms persist after 4-6 wk of t herapy. Our objective was to compare the efficacy of twice-daily treatment with either ranitidine 150 mg b.i.d. or 300 mg b.i.d. in resolving heartbur n in GERD patients who remained symptomatic after 6 wk of therapy with rani tidine 150 mg b.i.d. Methods: This was a two-phase, prospective study, In t he first phase, GERD patients with heartburn on greater than or equal to 4 of the 7 days before entry were treated with open-label ranitidine 150 mg b .i.d. for 6 wk, In the second phase, patients who were still symptomatic we re randomized to 8 wk of double-blind ranitidine therapy at either the same (150 mg b.i.d.) or a higher dose (300 mg b.i.d.). The primary efficacy var iable was the resolution of heartburn at wk 4 and 8, as monitored through d iary cards. Results: Of the 481 patients treated for 6 wk in phase I, 285 ( 59%) were still symptomatic; 271 patients (95% of those still symptomatic) were randomized to double-blind treatment with ranitidine. In phase II, 45% of the patients in each treatment group experienced no more than mild hear t-burn; complete heartburn resolution was observed in < 20% of patients in either group at wk 4 and 8, There were no significant differences in effica cy between the two treatment groups. Conclusions: These results indicate th at the majority of GERD patients still have symptoms of heartburn after 6 w k of ranitidine therapy. Only a minority of these patients experience compl ete relief of heartburn after an additional 8 wk of treatment, which demons trates that doubling the dose of ranitidine is not efficacious. (C) 1999 by Am. Cell. of Gastroenterology.