Statements & Guidelines


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

  1. Hypersecretory states.

  2. Gastro-oesophageal reflux disease in patients unable to take by mouth or swallow.

  3.  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.

  4. 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.

  5. 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