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Omeprazole before Endoscopy in Patients with Gastrointestinal Bleeding

rory spiegel

on 5 June 2013

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Transcript of PPIs for UGIB

The Hypothesis Are these the patients we treat with PPIs? Exclusion Criteria Is this how we treat patients with UGIB? What are the endpoints we care about?
1. Death
2. Blood loss
3. Re-bleeds 1. Daneshmend et al. 1,147 patients. Largest of the 4 studies. Trends towards increased mortality 1.6% mortality difference. Close to 5% increased mortality in the group with confirmed ulcers
2. Hasselgren et al. 330 patients. STOPPED EARLY for harm! 6.9% vs 0.6% mortality
3. Schaffalitzky et al. 265 patients. No mortality benefit. Mild decrease in need for second EGD Context
1. Daneshmend TK, Hawkey CJ, Langman MJ, et al. Omeprazole versus placebo for acute upper gastrointestinal bleeding: randomised double blind controlled trial. BMJ. 1992;304(6820):143-147.
2. Hasselgren G, Lind T, Lundell L, et al. Continuous intravenous infusion of omeprazole in elderly patients with peptic ulcer bleeding. Results of a placebo-controlled multicenter study. Scand. J. Gastroenterol. 1997;32(4):328-333.
3. Schaffalitzky de Muckadell OB, Havelund T, Harling H, et al. Effect of omeprazole on the outcome of endoscopically treated bleeding peptic ulcers. Randomized double- blind placebo-controlled multicentre study. Scand. J. Gastroenterol. 1997;32(4):320-327. "post hoc hypotheses is analogous to drawing the target around the bullet hole."

"suppose a sample of 1,000 patients is randomly allocated to 2 equally effective treatments, each with a mortality of 10%. If the data are now divided into 10 roughly equivalent subgroups, there is about a 99% chance that at least 1 subgroup will show one treatment to be twice as effective as the other, an 80% chance at least 1 subgroup will show an effect 3 times as large, and a 5% chance that at least 1 subgroup will identify one treatment as 10 times more effective than the other.13"

Wears RL, Cooper RJ, Magid DJ. Subgroups, reanalyses, and other dangerous things. Ann Emerg Med. 2005 Sep;46(3):253-5.
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