NEW YORK (Reuters Health) – In patients with acute coronary syndrome (ACS) or ST-elevation myocardial infarction (STEMI), the proton pump inhibitor (PPI) esomeprazole is superior to the H2-receptor antagonist (H2RA) famotidine for the prevention of gastrointestinal bleeding related to combination antiplatelet and anticoagulant therapy, a new study shows.
ACS or STEMI patients are now routinely treated with aspirin, clopidogrel, and heparin or thrombolytics to reduce cardiovascular morbidity and mortality. The major complication of these anti-ischemic therapies is gastrointestinal bleeding.
Yet, little is actually known about the efficacy of PPI therapy compared with H2RA therapy in preventing upper gastrointestinal complications in the population of patients with ACS or STEMI.
To investigate, Dr. Fook-Hong Ng from Ruttonjee Hospital, Hong Kong and colleagues compared the efficacy of oral esomeprazole (20 mg nightly) with oral famotidine (40 mg nightly) in a double-blind, randomized controlled trial involving 311 patients with ACS or STEMI; 163 took esomeprazole for an average of 19.2 weeks and 148 took famotidine for an average of 17.6 weeks.
The primary endpoint was upper gastrointestinal bleeding, perforation or obstruction from ulcer/erosion; one patient (0.6%) in the esomeprazole group and nine (6.1%) in the famotidine group reached the primary end point, all had upper gastrointestinal bleeding (P = 0.0052 by log-rank test; hazard ratio 0.95).
Dr. Ng and colleagues report their findings in the American Journal of Gastroenterology, available online now.
They say their findings support the 2010 recommendation from an expert panel of cardiologists and gastroenterologists to use a PPI rather than standard or double-dose H2RA therapy in patients receiving a combination of antiplatelet agents and anticoagulant.
The current study has provided “good evidence” that H2RA therapy is “inferior” to PPI therapy in the prevention of bleeding in this setting, the researchers write.
Dr. Ng and colleagues say further randomized, controlled studies are required to determine the effect of PPI therapy on major adverse cardiovascular events in patients with ACS or STEMI on combination antiplatelet/anticoagulant therapy.
Am J Gastroenterol 2011.