Professional Documents
Culture Documents
William J Roper
1
Studies
Daneshmend et al. Omeprazole vs placebo for acute
upper gastrointestinal bleeding: randomised double blind
controlled trial. BMJ 1992 Jan 18;304(6820):143-7.
Kaviani et al. Effect of oral omeprazole in reducing re-
bleeding in bleeding peptic ulcers: a prospective, double-
blind, randomized clinical trial. Aliment Pharmacol Ther
2003; 17: 211-216.
Baradarian et al. Early intensive resuscitation of patients
with upper gastrointestinal bleeding decreases mortality.
Am J Gastroenterol 2004; 99:619.
2
Study Design
Prospective, double blind, randomized,
placebo controlled, intent to treat.
Omeprazole 80mg IV, then 40mg IV TID
x3, then 40mg PO BID.
1147 patients (569 placebo 578 treated)
Outcomes: all cause mortality, rate of
rebleed, transfusion requirement, (and
effect of treatment on 1o endoscopy).
Daneshmend et al. Omeprazole vs placebo for acute upper
gastrointestinal bleeding: BMJ 1992 3
Criteria
Inclusion criteria: all patients with overt UGIB,
hematemesis or melena <24 hrs.
Exclusion criteria: age < 18, pregnant, severe
illness (terminal or advanced malignancy),
bleeding requiring immediate surgery, trivial
bleed, bleeding during previous admission,
prior participation in this study or inability to
start treatment in <12 hours, or
contraindication to medications (warfarin,
phenytoin)
Daneshmend et al. Omeprazole vs placebo for acute upper
gastrointestinal bleeding: BMJ 1992 4
Results
Death: Tx: 6.9% Placebo: 5.3% (ns)
Transfusion: Tx: 53% Placebo: 52% (ns)
Rebleed: Tx: 18% Placebo: 15% (ns)
Bleed Stigmata: Tx: 33% Placebo: 45% (p<0.0001)
Blood in stomach, red clot on lesion, active bleed,
black spot on lesion, visible vessel
“Our data do not justify the routine use of acid
inhibiting drugs in the management of haematemesis
or melaena.”
6
IV vs PO PPIs?
IV is quicker in onset, and more
expensive than PO.
There are currently no trials of IV vs PO
published
Is PO effective?
7
Study design
Prospective, double blind, randomized,
placebo controlled trial.
149 patients (treatment:71, placebo:78)
Omeprazole PO 20mg Q 6 hours
Hemodynamic compromise
No exclusion criteria
MI 5 2 0.04
Death 4 1 0.04
Baradarian et al. Early intensive resuscitation of patients
with UGIB decreases mortality. 2004.
16
In Practice
Prior to EGD, PPIs do not reduce
mortality, rebleeds or surgery, (might
make our GI colleagues job easier)
PO PPIs are effective in bleeding ulcers
(but only after receiving an EGD)
No data for PO vs IV
Early intervention in UGIB is a Good
Thing™
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