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Effective Maintenance Treatment of Reflux Esophagitis with Low-Dose Lansoprazole: A Randomized, Double-Blind, Placebo-Controlled Trial

Malcolm Robinson, MD; Frank Lanza, MD; Dennis Avner, MD; and Marian Haber, MD
[+] Article and Author Information

From University of Oklahoma College of Medicine, Oklahoma City, Oklahoma; Baylor College of Medicine, Houston, Texas; and Medical College of Pennsylvania and Hahnemann University, Philadelphia, Pennsylvania. Grant Support: By a grant from TAP Holdings, Inc., Deerfield, Illinois. Requests for Reprints: Malcolm Robinson, MD, Oklahoma Foundation for Digestive Research, University of Oklahoma College of Medicine, 711 Stanton L. Young Boulevard, Suite 501, Oklahoma City, OK 73104. Current Author Addresses: Dr. Robinson: Oklahoma Foundation for Digestive Research, University of Oklahoma College of Medicine, 711 Stanton L. Young Boulevard, Suite 501, Oklahoma City, OK 73104.


Copyright ©2004 by the American College of Physicians


Ann Intern Med. 1996;124(10):859-867. doi:10.7326/0003-4819-124-10-199605150-00001
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Objective: To compare the efficacy of two doses of lansoprazole with that of placebo in preventing recurrence of erosive esophagitis in a 12-month period.

Design: Randomized, double-blind, parallel, placebo-controlled trial.

Setting: 25 U.S. medical centers.

Patients: 173 patients with documented healing of erosive esophagitis after 8 weeks of acid-suppressing therapy.

Intervention: Lansoprazole, 15 mg or 30 mg, or placebo once daily for as long as 12 months.

Measurements: Endoscopy and symptom evaluation after 1,2,3,6,9, and 12 months of treatment. Endoscopy was also done whenever symptoms suggested erosive changes.

Results: Lansoprazole was significantly superior to placebo in maintaining healing and preventing recurrence of symptoms. By month 1, 45% of placebo recipients remained healed compared with more than 90% of patients in either lansoprazole group. By month 12, only 24% of placebo recipients 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 asymptomatic 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 controlling symptoms. Follow-up after recurrence of erosion indicated that during the 12 months, 35% of placebo recipients and 2% of lansoprazole recipients had three or more recurrences.

Conclusion: Lansoprazole effectively maintains healing of erosive esophagitis. The 15-mg and 30-mg lansoprazole doses did not differ significantly for use as maintenance treatment.

Figures

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Figure 1.
Proportion of patients who remained healed (that is, no erosions seen on endoscopy) during the 1-year maintenance period.P

Lansoprazole significantly improved maintenance of healing rates compared with placebo ( < 0.001). Within 1 month, 45% of placebo recipients remained healed compared with 93% of patients receiving 15 mg of lansoprazole and 98% of patients receiving 30 mg of lansoprazole.

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Figure 2.
Proportion of patients who remained healed (that is, no erosions seen on endoscopy) during the 1-year maintenance period, by treatment group and baseline esophagitis grade before healing.

No placebo recipients and 7 of 10 lansoprazole recipients with grade 4 esophagitis at baseline remained healed at 2 months. Lansoprazole was significantly superior to placebo in maintaining healing, even when data are stratified by baseline esophagitis grade. Percentages were calculated by life-table methods.

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Figure 3.
Proportion of patients who remained asymptomatic during the 1-year maintenance period.P

Lansoprazole (Lan) was significantly superior to placebo in controlling symptoms of daytime and nighttime heartburn ( < 0.001). At 12 months, 35% of placebo recipients were asymptomatic compared with 72% of patients receiving 15 mg of lansoprazole and 67% of patients receiving 30 mg of lansoprazole. Percentages were calculated by life-table methods; patient data were considered to be censored at the time of the first erosive recurrence. An asymptomatic state was defined as no moderate or severe daytime or nighttime heartburn.

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