Journal
NEW ENGLAND JOURNAL OF MEDICINE
Volume 379, Issue 23, Pages 2199-2208Publisher
MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa1714919
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Categories
Funding
- Innovation Fund Denmark [4108-00011A]
- Rigshospitalet
- Capital Region of Denmark
- Regions of Denmark
- Scandinavian Society of Anaesthesiology and Intensive Care Medicine
- Ehrenreich's Foundation
- Aase and Ejnar Danielsens Foundation
- Danish Society of Anesthesiology and Intensive Care Medicine
- Danish Medical Association
- European Society of Intensive Care Medicine
- Ferring Pharmaceuticals
- Fresenius Kabi
- CSL Behring
- Orion Pharma
- Abbott Nutrition International
- B. Braun Medical
- CSEM
- Edwards Lifesciences Services
- Kenta Biotech
- Maquet Critical Care
- Omnicare Clinical Research
- Nestle
- Pierre Fabre Pharma
- Pfizer
- Bard Medica
- Abbott
- Anandic Medical Systems
- PanGas Healthcare
- Bracco
- Hamilton Medical
- Getinge Group Maquet
- Drager
- Teleflex Medical
- GlaxoSmithKline
- Merck Sharp and Dohme
- Eli Lilly
- Baxter
- Astellas
- AstraZeneca
- Novartis
- Covidien
- Nycomed
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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.
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