Statements & Guidelines
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SAGES Clinical Practice Guidelines on the use of intravenously administered proton pump inhibitors (PPI)
Clinical situations in which intravenously
administered PPI may be appropriate are
- Hypersecretory states.
-
Gastro-oesophageal
reflux disease in patients unable to take by mouth or
swallow.
-
Upper gastro-intestinal haemorrhage.
A meta-analysis of 21 randomised controlled trials
evaluating proton pump inhibitors for bleeding ulcers
(with or without endoscopic therapy) found a significant
reduction in the risk of rebleeding (OR 0.40, 95 % CI
0.33 – 0.64) and the need for surgery (OR 0.59, 95 % CI
0.46 – 0.76) but no effect on mortality.
Upon
presentation and following resuscitation, patients
suspected to have bled from a gastric or duodenal ulcer
should receive Esomeprazole or Omeprazole or
Pantoprazole 80 mg intravenously over 30 minutes
followed by a continuous infusion of Esomepazole or
Omeprazole or Pantoprazole at a rate of 8 mg/h. At
present, Esomeprazole is the only intravenous PPI
registered for this indication in South Africa.
Endoscopy should be performed within 12 h with a view to
making a definitive diag-nosis and risk stratification.
Patients with ulcers at high risk of rebleeding (1A, 1B,
11A and 11B lesions according to the Forrest
Classification) should undergo endoscopic haemostasis
(injection therapy + thermal therapy or mechanical
therapy) in addition to receiving intravenous PPI
therapy. Individuals found to have bled from a gastric
or duodenal ulcer should receive a PPI by continuous
infusion for a total of 72 h before changing to an
orally administered PPI. In patients who have not bled
from a gastric or duodenal ulcer, the intravenous
infusion of PPI should be stopped and, if inhibition of
acid secretion is deemed necessary, changed to an oral
PPI.
-
Prevention of stress-related mucosal
disease (SRMD) in the Intensive Care Unit (ICU) setting.
Overt gastrointestinal bleeding occurs in 1.5 – 8.5
% of ICU patients and is associated with an increased
mortality. The need for prophylaxis in such patients is
widely accepted but there is disagreement as to which
clinical characteristics define high risk and what form
of prophylaxis is most appropriate.
Practice
guidelines developed by the American Society of Health
System Pharmacists recommend prophylaxis in the
following situations
a. History of
gastrointestinal ulceration or haemorrhage in the past
year and/or
b. Coagulopathy (platelet count <
50,000/mm³ and/or PTT ratio > 2.0 and/or INR > 1.5)
and/or
c. Mechanical ventilation for > 48 h and/or
d. Two or more minor risk factors (ICU admission lasting
more than 1 week, occult gastrointestinal bleeding
lasting > 5 days, high dose glucocorticoid therapy,
sepsis).
The risk of bleeding from SRMD can be
minimized by maintaining the intra-gastric pH > 3.5.
Antacids, H2 receptor antagonists (H2RA) and PPI raise
the intra-gastric pH and have all been shown to reduce
the incidence of overt gastrointestinal bleeding in ICU
patients. Several RCT and meta-analyses have however
suggested that prophylactic agents that increase the
intra-gastric pH may increase the risk of nosocomial
pneumonia. Su-cralfate, which does not raise the
intra-gastric pH, may however be mar-ginally less
effective than antacids and H2RA at preventing SRMD.
PPI can be administered orally, via naso-gastric
tube or intravenously but the dosage has not been
standardized. Oral formulations should be used in
patients able to swallow. Omeprazole enteric-coated
pellets may be used in patients who have a naso-gastric
tube in situ and intravenous formula-tions should only
be used in patients unable to take medication by mouth.
-
Certain clinical situations in which a
definitive diagnosis may not have been made but in which
the treating physician deems profound inhibition of acid
secretion necessary.
Investigations aimed at
establishing the appropriateness of such therapy should
be performed within a reasonable period of time.
Several intravenous formulations of PPI are available in
South Africa and the choice of which agent to use should
be at the discretion of the treating physician.
08/10/2009 22:05