EFFECT OF 3 RANITIDINE DOSAGE REGIMENS IN THE TREATMENT OF REFLUX ESOPHAGITIS - RESULTS OF A MULTICENTER TRIAL

Some patients with reflux oesophagitis fail to respond to standard H-2-receptor antagonist dosage regimens. The present study compared the effects of three different ranitidine dosage regimes: 300 mg post evening meal, 300 mg twice daily, or 300 mg at night in the treatment of this disease. All 508 patients studied had symptoms of gastro-oesophageal reflux and endoscopically confirmed erosive oesophagitis. Following endoscopy patients were randomized to treatment with one of the three dosage regimens. Follow-up endoscopy and symptom assessments were given after 4,8 and 12 weeks of treatment, though patients left the study if their oesophagitis had healed. At the first follow-up visit 424 patients had evaluable endoscopy data. Healing was achieved in 32% (300 mg at night), 34% (300 mg post evening meal) and 41% (33 mg twice daily) of patients. After 8 weeks cumulative healing was recorded in 55% (at night), 57% (post evening meal) and 66% (twice daily) of the population studied. By 12 weeks therapy these values had increased to 68%, 67 and 77%, respectively. In addition, between 11% and 24% of patients showed a marked improvement in the severity of their oesophagitis; this change was most apparent at the 4 week visit. Differences in healing between 300 mg twice daily and 30 mg at night or 300 mg post evening meal and 300 mg at night did not achieve statistical significance. Significantly more patents receiving 300 mg twice daily had complete relief of day and night-time heartburn compared with those receiving 300 mg at night (56 and 36% at 4 weeks, 66 and 38% at 8 weeks, 69 and 42% at 12 weeks). More patients receiving 300 mg post evening meal had relief of heartburn than those taking 300 mg at night at 8 weeks and 12 weeks but these differences were not statistically significant. Clinical adverse event profiles and laboratory data showed no difference between the treatments in terms of safety. We conclude that ranitidine 300 mg twice daily but not 300 mg post evening meal offers a significant advantage over the 300 mg at night regimen.