Long-term efficacy of lansoprazole in preventing relapse of erosive reflux esophagitis.

Author(s): Kovacs TO, Freston JW, Haber MM, Hunt B, Atkinson S, Peura DA

Affiliation(s): VA Greater Los Angeles Healthcare System, CURE Digestive Diseases Research Center, Los Angeles, CA 90073, USA. TKovacs@mednet.ucla.edu

Publication date & source: 2009-08, Dig Dis Sci., 54(8):1693-701. Epub 2009 Mar 7.

Publication type: Clinical Trial, Phase III; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

In a phase III study of lansoprazole treatment, patients with healed or unhealed erosive esophagitis entered a titrated open-label treatment period and received lansoprazole for <or=6 years to assess long-term maintenance therapy. Doses were adjusted depending on symptom response. Endoscopy was performed yearly. One hundred ninety-five subjects received lansoprazole for <1 to 72 months; most received daily doses of <or=30 mg. Lansoprazole maintained erosive esophagitis remission in 75% of subjects receiving treatment for <or=72 months, with 39 subjects experiencing 50 recurrences. Most subjects (94-95%) had no or mild symptoms of day or night heartburn at study end, and 77% were asymptomatic at first erosive esophagitis recurrence. The most common treatment-related adverse events included diarrhea (10%), headache (8%), and abdominal pain (6%), and were mild or moderate in severity. Long-term lansoprazole is effective and well tolerated when used to maintain erosive esophagitis remission for <or=6 years.