Low-dose ranitidine for the relief of heartburn

Background: Approximately 30% of adults in the USA suffer from heartburn or related symptoms monthly; more than 20% of these sufferers experience hear tburn at least once per day. Although many rely on self-medication with ant acids for the relief of their symptoms, treatments that decrease gastric vo lume as well as increase the pH of refluxed material should be more effecti ve in relieving heartburn. Aim: To compare the safety and efficacy of low-dose regimens of ranitidine for the relief of heartburn. Methods: Adults with at least a 3-month history of heartburn were eligible for this randomized, double-blind, parallel group, multicentre dose-ranging study. Following a 1-week open-label run-in phase to document baseline hea rtburn frequency, subjects were randomized to receive treatment with one ta blet of either ranitidine 75 mg (n = 491), ranitidine 25 mg (n = 504), or p lacebo (n = 494), to be taken as needed up to four times daily for 2 weeks for the relief of heartburn. Results: The ranitidine 75 mg regimen was clinically (> 10 percentage point s) and statistically (P < 0.05) significantly more effective than placebo f or ail measured efficacy end-points in relieving heartburn and reducing ant acid consumption, In addition, the ranitidine 75 mg regimen was superior to placebo in providing heartburn relief within 30 min of dosing that lasted for up to 12 h. Ranitidine 25 mg was observed to be statistically superior (P < 0.05) but not clinically different from placebo, as defined a priori, in providing heartburn relief. All treatments were well tolerated and adver se events occurred no more frequently with the ranitidine regimens than wit h placebo. Conclusions: Ranitidine 75 mg provides prompt relief of heartburn that last s for up to 12 h and has a safety profile comparable to that of placebo.