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Erschienen in:

12.03.2019 | Original

Pantoprazole prophylaxis in ICU patients with high severity of disease: a post hoc analysis of the placebo-controlled SUP-ICU trial

verfasst von: Søren Marker, Anders Perner, Jørn Wetterslev, Mette Krag, Theis Lange, Matt P. Wise, Mark Borthwick, Stepani Bendel, Frederik Keus, Anne Berit Guttormsen, Joerg C. Schefold, Morten Hylander Møller, The SUP-ICU investigators

Erschienen in: Intensive Care Medicine | Ausgabe 5/2019

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Abstract

Purpose

In the subgroup of patients with Simplified Acute Physiology Score (SAPS) II > 53 in the Stress Ulcer Prophylaxis in Intensive Care Unit (SUP-ICU) trial, there was interaction (P = 0.049) suggesting increased mortality in patients allocated to pantoprazole as compared with placebo. We aimed to explore this further.

Methods

The SUP-ICU trial allocated acutely admitted adults at risk of gastrointestinal bleeding to pantoprazole vs placebo. In this post hoc study, we repeated all the preplanned analyses of SUP-ICU in patients with baseline SAPS II > 53.

Results

A total of 1140 patients had a complete SAPS II > 53 and were included. At 90 days, 272/579 patients (47%) assigned to pantoprazole had died, as compared with 229/558 patients (41%) assigned to placebo [relative risk 1.13; 95% confidence interval (CI) 1.00–1.29]. This was supported by sensitivity analyses adjusted for risk factors and those in the per-protocol population. When accounting for patients with incomplete SAPS II in two additional analyses, the relative risk was 1.08; 95% CI 0.96–1.22 and 1.10; 95% CI 0.97–1.25. This was also observed for the secondary outcome days alive without life support. There were no differences between the intervention groups in the other secondary outcomes.

Conclusions

In this post hoc analysis of patients with high disease severity included in the SUP-ICU trial, we observed higher 90-day mortality and fewer days alive without life support with pantoprazole vs placebo. Some of this may have been explained by missing SAPS II data, but further research is needed to draw firm conclusions.

ClinicalTrials.gov

ClinicalTrials.gov No. NCT02467621.

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Titel: Pantoprazole prophylaxis in ICU patients with high severity of disease: a post hoc analysis of the placebo-controlled SUP-ICU trial
verfasst von: Søren Marker
Anders Perner
Jørn Wetterslev
Mette Krag
Theis Lange
Matt P. Wise
Mark Borthwick
Stepani Bendel
Frederik Keus
Anne Berit Guttormsen
Joerg C. Schefold
Morten Hylander Møller
The SUP-ICU investigators
Publikationsdatum: 12.03.2019
Verlag: Springer Berlin Heidelberg
Erschienen in: Intensive Care Medicine / Ausgabe 5/2019
Print ISSN: 0342-4642
Elektronische ISSN: 1432-1238
DOI: https://doi.org/10.1007/s00134-019-05589-y

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Pantoprazole prophylaxis in ICU patients with high severity of disease: a post hoc analysis of the placebo-controlled SUP-ICU trial