A new study published in NEJM reports that no significant differences were found between pantoprazole and placebo with regard to either 90-day mortality or the number of clinically important events among adult patients in the ICU who were at risk for gastrointestinal bleeding.
Critically ill patients in the intensive care unit (ICU) are at risk for stress-related gastrointestinal bleeding, which is associated with adverse outcomes. Patients in the ICU frequently receive prophylaxis for gastrointestinal stress ulceration but its risks and benefits are not certain. The quality of evidence supporting the prophylactic use of proton-pump inhibitors in the ICU is limited.
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Mette Krag et al. conducted a multicentered, parallel-group, blinded trial to evaluate the effects of adverse events associated with the prophylactic use of the proton-pump inhibitor pantoprazole in adult patients in the ICU who were at risk for gastrointestinal bleeding.
The study included 3298 patients out of which 1645 were randomly assigned to 40 mg of intravenous pantoprazole (a proton-pump inhibitor) group and 1653 to the placebo group.
The key study findings included are:
- At 90 days, 510 patients (31.1%) in the pantoprazole group and 499 (30.4%) in the placebo group had died.
- During the ICU stay, at least one clinically important event (a composite of clinically important gastrointestinal bleeding, pneumonia, Clostridium difficileinfection, or myocardial ischemia) had occurred in 21.9% of patients assigned to pantoprazole and 22.6% of those assigned to placebo.
- In the pantoprazole group, 2.5% of patients had clinically important gastrointestinal bleeding, as compared with 4.2% in the placebo group.
- The number of patients with infections or serious adverse reactions and the percentage of days alive without life support within 90 days was similar in the two groups.
“In this trial involving adult patients who were admitted to the ICU for an acute condition and were at risk for gastrointestinal bleeding, we found no significant differences between pantoprazole and placebo with regard to either 90-day mortality or the number of patients with a composite outcome of four clinically important events,” write the authors.
For reference log on to https://www.nejm.org/doi/full/10.1056/NEJMoa1714919