Lansoprazole heals erosive reflux esophagitis resistant to histamine H2-receptor antagonist therapy.
OBJECTIVE
We conducted a randomized, double-blind, multicenter clinical trial to determine whether lansoprazole was superior to continued therapy with histamine H2-receptor antagonist therapy in healing erosive reflux esophagitis.


METHODS
Investigators from nine medical centers enrolled 159 patients with endoscopically documented esophageal erosions and/or ulcers that had failed to heal with 12 or more wk of at least standard dosages of histamine H2-receptor antagonist therapy. Patients received ranitidine 150 mg b.i.d. for 8 wk or lansoprazole 30 mg for 4 wk followed by either lansoprazole 30 mg or lansoprazole 60 mg for another 4 wk of treatment. Patients underwent endoscopy at screening and at weeks 2, 4, and 8.


RESULTS
At 2, 4, and 8 wk of therapy, healing rates were significantly higher in the lansoprazole group compared with the ranitidine group (p < 0.001). By 8 wk, 84% of the lansoprazole group were healed as opposed to only 32% of the ranitidine group. Lansoprazole was superior to ranitidine in providing relief of upper abdominal burning and daytime heartburn (p < 0.001) and reducing the need for antacids (p < 0.001). Lansoprazole patients had less interference with sleep and less day time drowsiness than ranitidine patients (p = 0.05). The percentages of patients with adverse events were similar in both groups. Fasting serum gastrin levels at weeks 4 and 8 were significantly higher in the lansoprazole group compared with the ranitidine group.


CONCLUSIONS
Eight weeks of lansoprazole therapy is safe, superior to continued ranitidine therapy, and effective in healing more than 80% of patients with erosive reflux esophagitis previously resistant to histamine H2-receptor antagonist therapy.
Sontag
S J
SJ
Department of Medicine, Veterans Affairs Hospital, Hines, Illinois, USA.
Kogut
D G
DG
Fleischmann
R
R
Campbell
D R
DR
Richter
J
J
Robinson
M
M
McFarland
M
M
Sabesin
S
S
Lehman
G A
GA
Castell
D
D
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D000368:Aged; D000863:Antacids / Q000008:administration & dosage / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004351:Drug Resistance; D004942:Esophagitis, Peptic / Q000188:drug therapy*; D004945:Esophagoscopy; D005215:Fasting; D005260:Female; D005500:Follow-Up Studies; D005755:Gastrins / Q000097:blood; D006356:Heartburn / Q000188:drug therapy; D006635:Histamine H2 Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011899:Ranitidine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012449:Safety; D012890:Sleep / Q000187:drug effects; D012894:Sleep Stages / Q000187:drug effects; D014456:Ulcer / Q000188:drug therapy; D014945:Wound Healing
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000863:Antacids; D000897:Anti-Ulcer Agents; D005755:Gastrins; D006635:Histamine H2 Antagonists; D064747:Lansoprazole; D011899:Ranitidine; D009853:Omeprazole