The efficacy and safety of long-term, high-dose lansoprazole, a substituted benzimidizole proton pump inhibitor, on Barrett's esophagus was assessed. The issue is whether more complete control of acid reflux will lead to regression of Barrett's esophagus. Patients with Barrett's esophagus at least 3 cm in length (specialized columnar epithelium) were treated with 60 mg of lansoprazole each morning. Symptomatic, laboratory and endoscopic assessment was performed every 6 months. Length of Barrett's esophagus was measured, photo-documented and biopsied. Twenty- seven patients -- 23 male, 4 female, mean age 61 years -- were treated an average of 2.7 years.
Results: Symptoms improved from baseline to final visit in 19 patients (70.4%), worsened in one (3.7%), and remained unchanged in 7(25.9%). At baseline 10 patients had moderate or severe symptoms compared to none at the final visit. Thirteen patients had erosive esophagitis at baseline, all were healed at the final visit. While endoscopic measurement did not show a significant reduction in the length of Barrett's epithelium -- baseline mean 5.7 cm, final visit 5.3 cm -- by the final visit 20 of 26 patients had squamous islands, 6 with increased surface area, 12 newly developed on therapy, and 2 unchanged in size. Nine patients had squamous islands with a surface area >/=1 cm. Five patients had possibly or probably treatment related side-effects -- none was severe or caused discontinuation of the study medication. The mean fasting gastrin rose significantly on therapy. Of 20 patients followed >/=18 months, only one had a gastrin level >/= 400 pg/ml. There was no correlation between the density of Grimelius positive cells from gastric biopsies and gastrin elevation.
Conclusion: Lansoprazole 60 mg every day for up to 3 years was safe and effective in controlling symptoms and esophagitis. The impact on the extent of Barrett's esophagus over 2.7 years was manifested by the development and extension of squamous islands, the clinical significance of which will continue to be evaluated. This research is supported by a grant from TAP Pharmaceuticals Inc., Deerfield, IL.