Famotidine for the prevention of peptic ulcers and esophagitis in patients taking low-dose aspirin – FAMOUS Trial
A non-stop pharmaceutical battle…
FAMOUS trial is a Phase III, randomized, double blind, placebo-controlled trial funded
by the pharmaceuticals Merck and Astellas and published in 2009. In this study, Taha
et al, conclude that famotidine is effective in reducing gastric and duodenal ulcers as
well as erosive esophagitis in patients who require daily aspirin intake.
As a competitive inhibitor of histamine H2-receptors on the basolateral membrane of
parietal cells, Famotidine reduces gastric acid secretion. It was first developed by the
Japanese pharmaceutical Yamanouchi/Astellas and posteriorly marketed by Merck as
The study brought the attention of gastroenterologists and pharmaceuticals worldwide.
Soon after, on 2010, Fook-Hong et al, demonstrated that Famotidine is inferior to
Pantoprazole in preventing recurrence of aspirin-related peptic ulcers or erosions. This
clinical trial followed patients for 48 weeks (in contrast to 12-week follow-up in FAMOUS
trial) and the authors reported no conflicts of interest.
Years before FAMOUS trial was conducted, Taha et al, demonstrated on 1996 that high
dose Famotidine reduces the risk of NSAID induced gastric and duodenal ulcers
particularly important for patients with arthritis who require long-term NSAID use.
A multicenter study that used a protocol similar to the trial by Taha et al, failed to
demonstrate benefits of Famotidine in preventing NSAID-induced gastric ulcers, however,
this controversial study was never published as a full paper.
Where at we at, 22 years later?
On 2012, REDUCE trials 1&2 by Laine et al, tested a single-tablet combination of
Ibuprofen and Famotidine in prevention of gastric ulcers with a very small, yet
statistically significant, benefit for the treatment group. Furthermore, on 2014, Whellan et
al, demonstrated that a combined enteric coated aspirin/omeprazole tablet reduces
endoscopic gastric ulcers while improving ASA compliance in cardiac patients due to less
GI side effects.
On 2018, we count with 2 combination drugs: Duexis (Ibuprofen/Famotidine) approved
on 2011, 90 tabs cost $2883.67, and Vimovo (Naproxen/Esomeprazole) approved on
2010, 60 day cost $2473.37.
In conclusion, the work by Taha has opened a Pandora’s box for extensive research that is
left to be done, moreover, it has prepared the field for a never ending pharmaceutical
Daniela Guerrero Vinsard MD.
University of Connecticut Health Center.
Department of Internal Medicine.
Source: The Lancet
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