Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
E-pub ahead of print

Heterogeneity of treatment effect of prophylactic pantoprazole in adult ICU patients: a post hoc analysis of the SUP-ICU trial

Research output: Contribution to journalJournal articleResearchpeer-review

  1. Noninvasive respiratory support in the hypoxaemic peri-operative/periprocedural patient: a joint ESA/ESICM guideline

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Expert statement on the ICU management of patients with thrombotic thrombocytopenic purpura

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Intensive care medicine rapid practice guidelines (ICM-RPG): paving the road of the future

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Focus on fluid therapy in critically ill patients

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. APACHE II score validation in emergency abdominal surgery. A post hoc analysis of the InCare trial

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Effects of magnesium, phosphate and zinc supplementation in ICU patients-Protocol for a systematic review

    Research output: Contribution to journalReviewResearchpeer-review

View graph of relations

PURPOSE: The Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU) trial compared prophylactic pantoprazole with placebo in 3291 adult ICU patients at risk of clinically important gastrointestinal bleeding (CIB). As a predefined subgroup analysis suggested increased 90-day mortality with pantoprazole in the most severely ill patients, we aimed to further explore whether heterogenous treatment effects (HTE) were present.

METHODS: We assessed HTE in subgroups defined according to illness severity by SAPS II quintiles and the total number of risk factors for CIB using Bayesian hierarchical models, and on the continuous scale using Bayesian logistic regression models with interactions. Estimates were presented as posterior probability distributions of odds ratios (ORs), probabilities of different effect sizes, and marginal effects plots.

RESULTS: We observed potential HTE for 90-day mortality according to illness severity (median subgroup OR range 0.90-1.09) with higher risk in the most severely ill, but not with different numbers of risk factors (1.00-1.02). We observed potential HTE of pantoprazole for clinically important events (0.86-1.18) and infectious adverse events (0.88-1.27) with higher risk in patients with greater illness severity and in those with more risk factors for CIB. Pantoprazole substantially and consistently reduced the risk of CIB with no indications of HTE (0.53-0.63).

CONCLUSIONS: In this post hoc analysis of the SUP-ICU trial, we found indications of HTE with increased risks of serious adverse events in patients with greater illness severity or more risk factors for CIB allocated to pantoprazole. These findings are hypothesis-generating and warrant further prospective investigation. CLINICALTRIALS.

GOV IDENTIFIER: NCT02467621.

Original languageEnglish
JournalIntensive Care Medicine
ISSN0342-4642
DOIs
Publication statusE-pub ahead of print - 14 Jan 2020

    Research areas

  • Bayesian analysis, Gastrointestinal bleeding, Heterogeneity of treatment effects, Pantoprazole, Stress ulcer prophylaxis, Subgroup analysis

ID: 59134835