EFFECTIVE MAINTENANCE TREATMENT OF REFLUX ESOPHAGITIS WITH LOW-DOSE LANSOPRAZOLE - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Objective: To compare the efficacy of two doses of lansoprazole with t hat of placebo in preventing recurrence of erosive esophagitis in a 12 -month period. Design: Randomized, double-blind, parallel, placebo-con trolled trial. Setting: 25 U.S. medical centers. Patients: 173 patient s with documented healing of erosive esophagitis after 8 weeks of acid -suppressing therapy. Intervention: Lansoprazole, 15 mg or 30 mg, or p lacebo once daily for as long as 12 months. Measurements: Endoscopy an d symptom evaluation after 1, 2, 3, 6, 9, and 12 months of treatment. Endoscopy was also done whenever symptoms suggested erosive changes. R esults: Lansoprazole was significantly superior to placebo in maintain ing healing and preventing recurrence of symptoms. By month 1, 45% of placebo recipients remained healed compared with more than 90% of pati ents in either lansoprazole group. By month 12, only 24% of placebo re cipients remained healed compared with 79% of patients receiving 15 mg of lansoprazole and 90% of patients receiving 30 mg of lansoprazole. During the same period, 35% of placebo recipients remained asymptomati c compared with 72% of recipients of 15 mg of lansoprazole and 67% of recipients of 30 mg of lansoprazole. The 15-mg and 30-mg lansoprazole doses did not differ significantly in maintaining healing and controll ing symptoms. Follow-up after recurrence of erosion indicated that dur ing the 12 months, 35% of placebo recipients and 2% of lansoprazole re cipients had three or more recurrences. Conclusion: Lansoprazole effec tively maintains healing of erosive esophagitis. The 15-mg and 30-mg l ansoprazole doses did not differ significantly for use as maintenance treatment.