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Upper gastrointestinal bleeding and surrogate end points
  1. C Rollhauser1
  1. 1Gastroenterology and Hepatology Division, 346 Naciones Unidas, Córdoba, Córdoba 5016, Argentina; rollhaus@powernet.net.ar

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In their paper, Hawkey et al (Gut 2001;49:372–9) report on the use of blood in the stomach as a surrogate of hard end points such as rebleeding, need for surgery, and death in a group of patients with upper gastrointestinal bleeding randomised to placebo, tranexamic acid, lansoprazole, or both lansoprazole and tranexamic acid. Using logistic regression analyses, they found that blood in the stomach was predictive of clinical outcome and that the active medications decreased the gastric pool size at endoscopy. The authors suggest that although the medications did not significantly improve the rates of clinical outcomes, they would probably do so in a trial of sufficient sample size given the effect achieved on the surrogate endoscopic end point. These conclusions should be viewed with caution, if not with skepticism, for several reasons. Firstly, it is interesting that the authors chose the presence of blood in the stomach as a substitute end point based on a previous study in which no statistical difference was found for the prevalence of this endoscopic sign alone between patients randomised to placebo and omeprazole.1 Rather, …

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