Pantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU

Krag, Mette; Marker, Søren; Perner, Anders; Wetterslev, Jørn; Wise, Matt P; Schefold, Joerg C.; Keus, Frederik; Guttormsen, Anne B; Bendel, Stepani; Borthwick, Mark; Lange, Theis; Rasmussen, Bodil S; Siegemund, Martin; Bundgaard, Helle; Elkmann, Thomas; Jensen, Jacob V; Nielsen, Rune D; Liboriussen, Lisbeth; Bestle, Morten H; Elkjær, Jeanie M; ... (2018). Pantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU. The New England journal of medicine, 379(23), pp. 2199-2208. Massachusetts Medical Society 10.1056/NEJMoa1714919

Text 2018 - Krag - NEJMoa - PMID 30354950 .pdf - Published Version Restricted to registered users only Available under License Publisher holds Copyright. Download (291kB)

BACKGROUND

Prophylaxis for gastrointestinal stress ulceration is frequently given to patients in the intensive care unit (ICU), but its risks and benefits are unclear.

METHODS

In this European, multicenter, parallel-group, blinded trial, we randomly assigned adults who had been admitted to the ICU for an acute condition (i.e., an unplanned admission) and who were at risk for gastrointestinal bleeding to receive 40 mg of intravenous pantoprazole (a proton-pump inhibitor) or placebo daily during the ICU stay. The primary outcome was death by 90 days after randomization.

RESULTS

A total of 3298 patients were enrolled; 1645 were randomly assigned to the pantoprazole group and 1653 to the placebo group. Data on the primary outcome were available for 3282 patients (99.5%). At 90 days, 510 patients (31.1%) in the pantoprazole group and 499 (30.4%) in the placebo group had died (relative risk, 1.02; 95% confidence interval [CI], 0.91 to 1.13; P=0.76). During the ICU stay, at least one clinically important event (a composite of clinically important gastrointestinal bleeding, pneumonia, Clostridium difficile infection, or myocardial ischemia) had occurred in 21.9% of patients assigned to pantoprazole and 22.6% of those assigned to placebo (relative risk, 0.96; 95% CI, 0.83 to 1.11). 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 were similar in the two groups.

CONCLUSIONS

Among adult patients in the ICU who were at risk for gastrointestinal bleeding, mortality at 90 days and the number of clinically important events were similar in those assigned to pantoprazole and those assigned to placebo. (Funded by Innovation Fund Denmark and others; SUP-ICU ClinicalTrials.gov number, NCT02467621 .).

Interest & Impact

Downloads

2 since deposited on 31 Oct 2018
0 in the past 12 months

Citations

5 Citations in Web of Science ®
6 Citations in Scopus

Search

in Google Scholar™

Services

Actions (login required)

Edit item

Actions (login required)

Edit item