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      Efficacy and safety of proton pump inhibitors for stress ulcer prophylaxis in critically ill patients: a systematic review and meta-analysis of randomized trials

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          Abstract

          Background

          The relative efficacy and safety of proton pump inhibitors (PPIs) compared to histamine-2-receptor antagonists (H2RAs) should guide their use in reducing bleeding risk in the critically ill.

          Methods

          We searched the Cochrane library, MEDLINE, EMBASE, ACPJC, clinical trials registries, and conference proceedings through November 2015 without language or publication date restrictions. Only randomized controlled trials (RCTs) of PPIs vs H2RAs for stress ulcer prophylaxis in critically ill adults for clinically important bleeding, overt gastrointestinal (GI) bleeding, nosocomial pneumonia, mortality, ICU length of stay and Clostridium difficile infection were included. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess our confidence in the evidence for each outcome.

          Results

          In 19 trials enrolling 2117 patients, PPIs were more effective than H2RAs in reducing the risk of clinically important GI bleeding (RR 0.39; 95 % CI 0.21, 0.71; P = 0.002; I 2  = 0 %, moderate confidence) and overt GI bleeding (RR 0.48; 95 % CI 0.34, 0.66; P < 0.0001; I 2  = 3 %, moderate confidence). PPI use did not significantly affect risk of pneumonia (RR 1.12; 95 % CI 0.86, 1.46; P = 0.39; I 2  = 2 %, low confidence), mortality (RR 1.05; 95 % CI 0.87, 1.27; P = 0.61; I 2  = 0 %, moderate confidence), or ICU length of stay (mean difference (MD), –0.38 days; 95 % CI –1.49, 0.74; P = 0.51; I 2  = 30 %, low confidence). No RCT reported Clostridium difficile infection.

          Conclusions

          PPIs were superior to H2RAs in preventing clinically important and overt GI bleeding, without significantly increasing the risk of pneumonia or mortality. Their impact on Clostridium difficile infection is yet to be determined.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s13054-016-1305-6) contains supplementary material, which is available to authorized users.

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          Most cited references32

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          GI complications in patients receiving mechanical ventilation.

          Go¨khan Mutlu, Ece Mutlu, Phillip Factor (2001)
          Mechanical ventilation (MV) can be lifesaving by maintaining gas exchange until the underlying disorders are corrected, but it is associated with numerous organ-system complications, which can significantly affect the outcome of critically ill patients. Like other organ systems, GI complications may be directly attributable to MV, but most are a reflection of the severity of the underlying disease that required intensive care. The interactions of the underlying critical illness and MV with the GI tract are complex and can manifest in a variety of clinical pictures. Incorporated in this review are discussions of the most prevalent GI complications associated with MV, and current diagnosis and management of these problems.
          Article 0 comments Cited 74 times – based on 0 reviews     Review now
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            The attributable mortality and length of intensive care unit stay of clinically important gastrointestinal bleeding in critically ill patients

            Deborah Cook, Lauren Griffith, Stephen Walter … (2001)
            Objective To estimate the mortality and length of stay in the intensive care unit (ICU) attributable to clinically important gastrointestinal bleeding in mechanically ventilated critically ill patients. Design Three strategies were used to estimate the mortality attributable to bleeding in two multicentre databases. The first method matched patients who bled with those who did not (matched cohort), using duration of ICU stay prior to the bleed, each of six domains of the Multiple Organ Dysfunction Score (MODS) measured 3 days prior to the bleed, APACHE II score, age, admitting diagnosis, and duration of mechanical ventilation. The second approach employed Cox proportional hazards regression to match bleeding and non-bleeding patients (model-based matched cohort). The third method, instead of matching, derived estimates based on regression modelling using the entire population (regression method). Three parallel analyses were conducted for the length of ICU stay attributable to clinically important bleeding. Setting Sixteen Canadian university-affiliated ICUs. Patients A total of 1666 critically ill patients receiving mechanical ventilation for at least 48 hours. Measurements We prospectively collected data on patient demographics, APACHE II score, admitting diagnosis, daily MODS, clinically important bleeding, length of ICU stay, and mortality. Independent adjudicators determined the occurrence of clinically important gastrointestinal bleeding, defined as overt bleeding in association with haemodynamic compromise or blood transfusion. Results Of 1666 patients, 59 developed clinically important gastrointestinal bleeding. The mean APACHE II score was 22.9 ± 8.6 among bleeding patients and 23.3 ± 7.7 among non-bleeding patients. The risk of death was increased in patients with bleeding using all three analytic approaches (matched cohort method: relative risk [RR]= 2.9, 95% confidence interval (CI)= 1.6–5.5; model-based matched cohort method: RR = 1.8, 95% CI = 1.1–2.9; and the regression method: RR = 4.1, 95% CI = 2.6–6.5). However, this was not significant for the adjusted regression method (RR = 1.0, 95% CI = 0.6–1.7). The median length of ICU stay attributable to clinically important bleeding for these three methods, respectively, was 3.8 days (95% CI = -0.01 to 7.6 days), 6.7 days (95% CI = 2.7–10.7 days), and 7.9 days (95% CI = 1.4–14.4 days). Conclusions Clinically important upper gastrointestinal bleeding has an important attributable morbidity and mortality, associated with a RR of death of 1–4 and an excess length of ICU stay of approximately 4–8 days.
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              Review article: proton pump inhibitors and bacterial overgrowth.

              Geoffrey Williams, Kenneth E L McColl (2006)
              Proton pump inhibitors are potent drugs producing profound suppression of gastric acid secretion. Consequently, they are highly effective at treating acid-related disorders. There have been concerns that the suppression of gastric acid will alter the bacterial flora of the upper gastrointestinal tract and lead to complications such as cancer, enteric or other infections and malabsorption. Studies have confirmed that proton pump inhibitors do alter the bacterial population but present evidence indicates that this only rarely leads to clinical disease. As with all drugs, proton pump inhibitors should only be used for disorders shown clearly to benefit from the therapy and where the benefits will outweigh the small risks associated with them. Further research to more fully quantify the risk associated with PPI therapy is required.
              Article 0 comments Cited 46 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Waleed Alhazzani: alhazzaw@mcmaster.ca
                Journal
                Journal ID (nlm-ta): Crit Care
                Title: Critical Care
                Publisher: BioMed Central (London )
                ISSN (Print): 1364-8535
                ISSN (Electronic): 1466-609X
                Publication date (Electronic): 4 May 2016
                Publication date PMC-release: 4 May 2016
                Publication date (Print): 2016
                Volume: 20
                Electronic Location Identifier: 120
                Affiliations
                [ ]Department of Medicine, McMaster University, Hamilton, Canada
                [ ]Department of Internal Medicine, United Arab Emirates University, Alain, United Arab Emirates
                [ ]Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Canada
                [ ]Department of Surgery, Division of Neurosurgery, McMaster University, Hamilton, Canada
                [ ]Department of Critical Care, Security Forces Hospital, Riyadh, Saudi Arabia
                [ ]Department of Medicine, Alfaisal University, Riyadh, Saudi Arabia
                [ ]Department of Medicine, Division of Critical Care, St Joseph’s Healthcare, 50 Charlton Avenue East, Hamilton, ON L8N 4A6 Canada
                Article
                Publisher ID: 1305
                DOI: 10.1186/s13054-016-1305-6
                PMC ID: 4855320
                PubMed ID: 27142116
                SO-VID: 7a6b7488-34f9-467c-88a8-002ee99d599d
                Copyright © © Alshamsi et al. 2016
                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                Date received : 20 March 2016
                Date accepted : 19 April 2016
                Funding
                Funded by: Canadian Intensive Care Foundation
                Funded by: Critical Care Medicine Residency Program
                Funded by: Critical Care Division McMaster University
                Categories
                Subject: Research
                Custom metadata
                issue-copyright-statement © The Author(s) 2016

                ScienceOpen disciplines: Emergency medicine & Trauma
                Data availability:
                ScienceOpen disciplines: Emergency medicine & Trauma

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