[AF] ulcera peptica y cardioproteccion

[emilio pol yanguas]

Famotidina es efectiva en la prevención de la úlcera péptica gástrica y
duodenal, y la esofagitis erosiva, en personas que toman AAS a dosis bajas
como cardioprotección. Según un artículo publicado esta semana en Lancet,
adjunto acceso al resumen 
<http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2809%2961246-0/abstract>

The Lancet,
<http://www.thelancet.com/journals/lancet/issue/vol374no9684/PIIS0140-6736(09)X6082-4> Volume 374, Issue 9684, Pages 119 - 125, 11 July 2009


Famotidine for the prevention of peptic ulcers and oesophagitis in patients
taking low-dose aspirin (FAMOUS): a phase III, randomised, double-blind,
placebo-controlled trial


Original Text

Dr Ali S Taha MD, Caroline McCloskey BSc, Rakesh Prasad MRCP, Vladimir Bezlyak PhD
Summary
Background
There are few therapeutic options for the prevention of gastrointestinal
mucosal damage caused by low-dose aspirin. We therefore investigated the
efficacy of famotidine, a well-tolerated histamine H2-receptor antagonist,
in the prevention of peptic ulcers and erosive oesophagitis in patients
receiving low-dose aspirin for vascular protection.

Methods
Adult patients (aged ≥18 years) from the cardiovascular, cerebrovascular,
and diabetes clinics at Crosshouse Hospital, Kilmarnock, UK, were eligible
for enrolment in this phase III, randomised, double-blind,
placebo-controlled trial if they were taking aspirin 75―325 mg per day with
or without other cardioprotective drugs. Patients without ulcers or erosive
oesophagitis on endoscopy at baseline were randomly assigned by
computer-generated randomisation sequence to receive famotidine 20 mg twice
daily (n=204) or placebo twice daily (n=200). Patients had a final
endoscopic examination at 12 weeks. The primary endpoint was the development
of new ulcers in the stomach or duodenum or erosive oesophagitis at 12 weeks
after randomisation. Analysis was by intention to treat, including all
randomised patients who received at least one dose of study drug (famotidine
or placebo). This trial is registered as an International Standard
Randomised Clinical Trial, number ISRCTN96975557.

Findings
All randomised patients received at least one dose and were included in the
ITT population. 82 patients (famotidine, n=33; placebo, n=49) did not have
the final endoscopic examination and were assumed to have had normal
findings; the main reason for participant withdrawal was refusal to
continue. At 12 weeks, comparing patients assigned to famotidine with
patients assigned to placebo, gastric ulcers had developed in seven (3・4%)
of 204 patients compared with 30 (15・0%) of 200 patients (odds ratio [OR]
0・20, 95% CI 0・09―0・47; p=0・0002); duodenal ulcers had developed in one
(0・5%) patient compared with 17 (8・5%; OR 0・05, 0・01―0・40; p=0・0045);
and erosive oesophagitis in nine (4・4%) compared with 38 (19・0%; OR 0・20,
0・09―0・42; p<0・0001), respectively. There were fewer adverse events in
the famotidine group than in the placebo group (nine vs 15); four patients
in the placebo group were admitted to hospital with upper gastrointestinal
haemorrhage. The other most common adverse event was angina (famotidine,
n=2; placebo, n=4).

Interpretation
Famotidine is effective in the prevention of gastric and duodenal ulcers,
and erosive oesophagitis in patients taking low-dose aspirin. These findings
widen the therapeutic options for the prevention of gastrointestinal damage
in patients needing vascular protection.

Funding
Merck Laboratories and Astellas Pharma.

 
Algunos digestivos y cardiólogos consideraban inadecuado sustituir
omeprazol por famotidina en casos de pacientes que tomaban copidogrel y AAs,
argumentando ineficacia. Este ensayo clínico, aunque no compara omeprazol
frente a famotidina  parece apoyar, sin embargo, la famotidina como una
alternativa adecuada a omeprazol en estos pacientes