Long-term efficacy of lansoprazole in preventing relapse of erosive reflux esophagitis.
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.
Kovacs
Thomas O
TO
VA Greater Los Angeles Healthcare System, CURE Digestive Diseases Research Center, Los Angeles, CA 90073, USA. TKovacs@mednet.ucla.edu
Freston
James W
JW
Haber
Marian M
MM
Hunt
Barbara
B
Atkinson
Stuart
S
Peura
David A
DA
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D015746:Abdominal Pain / Q000139:chemically induced; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003967:Diarrhea / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004361:Drug Tolerance; D004942:Esophagitis, Peptic / Q000517:prevention & control*; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D064747:Lansoprazole; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D055502:Secondary Prevention; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D054328:Proton Pump Inhibitors; D064747:Lansoprazole