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Pantoprazole in ICU patients at risk for gastrointestinal bleeding-1-year mortality in the SUP-ICU trial

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@article{6b9c3b3e306548308ef4aa2a31032594,
title = "Pantoprazole in ICU patients at risk for gastrointestinal bleeding-1-year mortality in the SUP-ICU trial",
abstract = "BACKGROUND: The long-term effects of stress ulcer prophylaxis with pantoprazole are unknown in ICU patients. We report 1-year mortality outcome in the Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU) trial.METHODS: In the SUP-ICU trial, acutely admitted adult ICU patients at risk of gastrointestinal bleeding were randomised to intravenous pantoprazole 40 mg vs placebo (saline) once daily during their ICU stay. We assessed mortality at 1 year and did sensitivity analyses according to the trial protocol and statistical analysis plan.RESULTS: A total of 3261 of the 3291 patients with available data (99.1{\%}) were followed up at 1 year after randomisation; 1635 were allocated to pantoprazole and 1626 to placebo. At 1 year after randomisation, 610 of 1635 patients (37.3{\%}) had died in the pantoprazole group as compared with 601 of 1626 (37.0{\%}) in the placebo group (relative risk, 1.01; 95{\%} confidence interval 0.92-1.10). The results were consistent in the sensitivity analysis adjusted for baseline risk factors and in those of the per-protocol population. We did not observe heterogeneity in the effect of pantoprazole vs placebo on 1-year mortality in the predefined subgroups, that is, patients with and without shock, mechanical ventilation, liver disease, coagulopathy, high disease severity (SAPS II > 53) or in medical vs surgical ICU patients.CONCLUSION: We did not observe a difference in 1-year mortality among acutely admitted adult ICU patients with risk factors for gastrointestinal bleeding allocated to stress ulcer prophylaxis with pantoprazole or placebo during the ICU stay. (The SUP-ICU trial was funded by Innovation Fund Denmark and others; ClinicalTrials.gov number, NCT02467621).",
author = "S{\o}ren Marker and Mette Krag and Anders Perner and J{\o}rn Wetterslev and Theis Lange and Wise, {Matt P} and Mark Borthwick and Stepani Bendel and Frederik Keus and Guttormsen, {Anne Berit} and Schefold, {Joerg C} and Rasmussen, {Bodil S} and Thomas Elkmann and Morten Bestle and Bj{\o}rn Arenkiel and Laake, {Jon H} and Kamper, {Maj K} and Maarit L{\aa}ng and Pawlowicz-Dworzanska, {Malgorzata B} and Sari Karlsson and Janne Liisanantti and Nilanjan Dey and Heidi Knudsen and Anders Granholm and {SUP-ICU trial investigators} and M{\o}ller, {Morten Hylander}",
note = "{\circledC} 2019 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.",
year = "2019",
month = "7",
day = "8",
doi = "10.1111/aas.13436",
language = "English",
journal = "Acta Anaesthesiologica Scandinavica",
issn = "0001-5172",
publisher = "Wiley-Blackwell Munksgaard",

}

RIS

TY - JOUR

T1 - Pantoprazole in ICU patients at risk for gastrointestinal bleeding-1-year mortality in the SUP-ICU trial

AU - Marker, Søren

AU - Krag, Mette

AU - Perner, Anders

AU - Wetterslev, Jørn

AU - Lange, Theis

AU - Wise, Matt P

AU - Borthwick, Mark

AU - Bendel, Stepani

AU - Keus, Frederik

AU - Guttormsen, Anne Berit

AU - Schefold, Joerg C

AU - Rasmussen, Bodil S

AU - Elkmann, Thomas

AU - Bestle, Morten

AU - Arenkiel, Bjørn

AU - Laake, Jon H

AU - Kamper, Maj K

AU - Lång, Maarit

AU - Pawlowicz-Dworzanska, Malgorzata B

AU - Karlsson, Sari

AU - Liisanantti, Janne

AU - Dey, Nilanjan

AU - Knudsen, Heidi

AU - Granholm, Anders

AU - SUP-ICU trial investigators

AU - Møller, Morten Hylander

N1 - © 2019 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

PY - 2019/7/8

Y1 - 2019/7/8

N2 - BACKGROUND: The long-term effects of stress ulcer prophylaxis with pantoprazole are unknown in ICU patients. We report 1-year mortality outcome in the Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU) trial.METHODS: In the SUP-ICU trial, acutely admitted adult ICU patients at risk of gastrointestinal bleeding were randomised to intravenous pantoprazole 40 mg vs placebo (saline) once daily during their ICU stay. We assessed mortality at 1 year and did sensitivity analyses according to the trial protocol and statistical analysis plan.RESULTS: A total of 3261 of the 3291 patients with available data (99.1%) were followed up at 1 year after randomisation; 1635 were allocated to pantoprazole and 1626 to placebo. At 1 year after randomisation, 610 of 1635 patients (37.3%) had died in the pantoprazole group as compared with 601 of 1626 (37.0%) in the placebo group (relative risk, 1.01; 95% confidence interval 0.92-1.10). The results were consistent in the sensitivity analysis adjusted for baseline risk factors and in those of the per-protocol population. We did not observe heterogeneity in the effect of pantoprazole vs placebo on 1-year mortality in the predefined subgroups, that is, patients with and without shock, mechanical ventilation, liver disease, coagulopathy, high disease severity (SAPS II > 53) or in medical vs surgical ICU patients.CONCLUSION: We did not observe a difference in 1-year mortality among acutely admitted adult ICU patients with risk factors for gastrointestinal bleeding allocated to stress ulcer prophylaxis with pantoprazole or placebo during the ICU stay. (The SUP-ICU trial was funded by Innovation Fund Denmark and others; ClinicalTrials.gov number, NCT02467621).

AB - BACKGROUND: The long-term effects of stress ulcer prophylaxis with pantoprazole are unknown in ICU patients. We report 1-year mortality outcome in the Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU) trial.METHODS: In the SUP-ICU trial, acutely admitted adult ICU patients at risk of gastrointestinal bleeding were randomised to intravenous pantoprazole 40 mg vs placebo (saline) once daily during their ICU stay. We assessed mortality at 1 year and did sensitivity analyses according to the trial protocol and statistical analysis plan.RESULTS: A total of 3261 of the 3291 patients with available data (99.1%) were followed up at 1 year after randomisation; 1635 were allocated to pantoprazole and 1626 to placebo. At 1 year after randomisation, 610 of 1635 patients (37.3%) had died in the pantoprazole group as compared with 601 of 1626 (37.0%) in the placebo group (relative risk, 1.01; 95% confidence interval 0.92-1.10). The results were consistent in the sensitivity analysis adjusted for baseline risk factors and in those of the per-protocol population. We did not observe heterogeneity in the effect of pantoprazole vs placebo on 1-year mortality in the predefined subgroups, that is, patients with and without shock, mechanical ventilation, liver disease, coagulopathy, high disease severity (SAPS II > 53) or in medical vs surgical ICU patients.CONCLUSION: We did not observe a difference in 1-year mortality among acutely admitted adult ICU patients with risk factors for gastrointestinal bleeding allocated to stress ulcer prophylaxis with pantoprazole or placebo during the ICU stay. (The SUP-ICU trial was funded by Innovation Fund Denmark and others; ClinicalTrials.gov number, NCT02467621).

U2 - 10.1111/aas.13436

DO - 10.1111/aas.13436

M3 - Journal article

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

SN - 0001-5172

ER -

ID: 57626471