NEW YORK (Reuters Health) – Lansoprazole and famotidine have comparable effects in preventing recurrent idiopathic gastroduodenal ulcer bleeding, a two-year randomized clinical trial shows.
“A small difference in efficacy between lansoprazole and famotidine cannot be excluded,” Dr. Grace L. H. Wong and Dr. Francis K. L. Chan of The Chinese University of Hong Kong told Reuters Health in a joint email.
Helicobacter pylori-negative idiopathic ulcers, now recognized as a distinct disease entity from H. pylori-associated ulcers, carry a much higher risk of recurrent bleeding, Dr. Wong and Dr. Chan note in Gut, online June 22.
Long-term proton pump inhibitor (PPI) treatment is recommended for these patients, they add, but the comparative efficacy of histamine H2-receptor antagonists (H2RA) had not been investigated.
“This is a clinically relevant question since our previous study showed that many patients with H. pylori-negative idiopathic ulcer bleeding had histological features of achlorhydria,” the authors note.
They randomly assigned 228 patients with H. pylori-negative peptic ulcers, after ulcer healing, to oral lansoprazole 30 mg or famotidine 40 mg daily for 24 months. Recurrent upper GI bleeding occurred in 0.88% of patients on lansoprazole and in 2.63% of those on famotidine (P=0.313).
The findings show that “acid suppression alone by either PPI or H2RA is not sufficient to completely abolish the risk of recurrent ulcer or gastrointestinal bleeding,” Dr. Wong and Dr. Chan write. “We are now working on another randomised trial to test the hypothesis that a combination therapy of misoprostol and lansoprazole is superior to lansoprazole alone for the prevention of recurrent ulcer bleeding in patients with a history of idiopathic ulcer bleeding (ClinicalTrials.gov registration number NCT03675672).”
They add: “Some of the patients had clinical gastrointestinal bleeding but no bleeding source was identified in the upper gastrointestinal tract. Some of these patients were adjudicated to have lower gastrointestinal bleeding; the two-year cumulative incidence rate was 1.75% in lansoprazole arm and 0.88% in famotidine arm. Our ongoing randomised trial would be important to illustrate the impact of misoprostol on reducing the risk of lower gastrointestinal bleeding.”