There are many patients worldwide on low-dose Acetylsalicylic acid ( Aspirin ) for a variety of conditions, yet few treatments available to treat the damage that can be caused to the lining of the stomach and upper intestine that can be caused by this damage.
The FAMOUS trial has shown that Famotidine ( Pepcid ) is effective in the prevention of stomach and upper intestinal ulcers, and damage to the gullet.

Low-dose Acetylsalicylic acid ( 75-325mg ) is one of the most widely used drugs in the world. Increasingly, it is being bought over the counter or prescribed for its anti-clotting activity in the heart and brain, and in patients with diabetes. Despite the benefits of Acetylsalicylic acid use, its rise has been accompanied by a rise in gastrointestinal complications, such as peptic ulcer bleeding, perforation, and sometimes death.

Proton-pump inhibitors ( PPIs ), such as Omeprazole ( Prilosec ) and Lansoprazole ( Prevacid ), can prevent such ulcers but there have been concerns about cost, safety, and risk of interaction with Clopidogrel ( Plavix ), another anti-clotting drug which is often prescribed with Aspirin.

In this phase III randomised, controlled trial ( FAMOUS study ), Ali S Taha, Crosshouse Hospital, Kilmarnock, UK and University of Glasgow, UK, and colleagues studied the effect Famotidine, which has a different mechanism of action to proton-pump inhibitors and belongs to a group of drugs called H2-receptor antagonists.
Famotidine lowers acidity by binding to the histamine particles in the stomach, and is broken down by different enzymes in the liver. This explains its gentler action compared with proton-pump inhibitors, particularly in patients requiring the other anti-clotting drug, Clopidogrel.

Adult patients from Crosshouse Hospital were eligible for the study if they were taking Acetylsalicylic acid 75-325mg per day with or without cardioprotective drugs. Patients were given Famotidine 20mg twice daily ( 204 patients ) or placebo twice daily ( 200 patients ). They were then given an endoscopic examination at 12 weeks.

The researchers found that stomach ulcers had developed in 3% of patients given Famotidine compared with 15% given placebo. Upper-intestinal or duodenal ulcers were found in just one patient ( 0.5% ) in the Famotidine group compared with 17% of those given placebo. Gullet ulcers occurred in 4% of Famotidine patients compared with 19% of placebo patients. There were fewer adverse events in the Famotidine group ( 9 vs 15 placebo ).

The study has shown that Famotidine is effective in the prevention of gastric and duodenal ulcers, and erosive oesophagitis in patients taking low-dose Acetylsalicylic acid.

There is little doubt that Acetylsalicylic acid and other anti-clotting drugs are very useful in the prevention of heart, brain, and other vascular diseases, hence their increasing use world-wide. Patients on such drugs should continue using them as advised by their family doctors or hospital specialists. However, everybody should be aware that Acetylsalicylic acid use can also be associated with a variety of gastrointestinal or digestive system problems, which sometimes can be serious. The results of this research widen the options for the prevention of such problems particularly when more than one clotting drug is required.

Source: The Lancet, 2009

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