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      Risk factors for cardiopulmonary and respiratory arrest in medical and surgical hospital patients on opioid analgesics and sedatives

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          Abstract

          Background

          Opioid induced respiratory depression is a known cause of preventable death in hospitals. Medications with sedative properties additionally potentiate opioid-induced respiratory and sedative effects, thereby elevating the risk for adverse events. The goal of this study was to determine what specific factors increase the risk of in-hospital cardiopulmonary and respiratory arrest (CPRA) in medical and surgical patients on opioid and sedative therapy.

          Methods

          The present study analyzed 14,504,809 medical inpatient and 6,771,882 surgical inpatient discharges reported into the Premier database from 2008 to 2012. Patients were divided in four categories: on opioids; on sedatives; on both opioids and sedatives; and on neither opioids nor sedatives.

          Results

          During hospital admission, 57% of all medical patients and 90% of all surgical patients were prescribed opioids, sedatives, or both. Surgical patients had a higher incidence of CPRA than medical patients (6.17 vs. 3.77 events per 1000 admissions; Relative Risk: 1.64 [95%CI: 1.62–1.66; p<0.0001). Opioids and sedatives were found to be independent predictors of CPRA (adjusted OR of 2.24 [95%CI: 2.18–2.29] for opioids and adjusted OR 1.80 [95%CI: 1.75–1.85] for sedatives in medical patients, and adjusted OR of 1.12 [95%CI: 1.07–1.16] for opioids and adjusted OR of 1.58 [95%CI: 1.51–1.66] for sedatives in surgical patients), with the highest risk in groups who received both types of medications (adjusted OR of 3.83 [95% CI: 3.74–3.92] in medical patients, and adjusted OR of 2.34 [95% CI: 2.25–2.42] in surgical patients) compared with groups that received neither type of medication. The common risk factors of CPRA in medical and surgical patients receiving both opioids and sedatives were Hispanic origin, mild liver disease, obesity, and COPD. Additionally, medical and surgical groups had their own unique risk factors for CPRA when placed on opioid and sedative therapy.

          Conclusions

          Opioids and sedatives are independent and additive predictors of CPRA in both medical and surgical patients. Receiving both classes of medications further exacerbates the risk of CPRA for these patients. By identifying groups at risk among medical and surgical in-hospital patients, this study provides a step towards improving our understanding of how to use opioid and sedative medications safely, which may influence our treatment strategies and outcomes. More precise monitoring of selected high-risk patients may help prevent catastrophic cardiorespiratory complications from these medications. As a retrospective administrative database analysis, this study does not establish the causality or the temporality of the events but rather draws statistically significant associations between the clinical factors and outcomes.

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          Most cited references37

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          2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society.

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            Immune dysfunction in patients with diabetes mellitus (DM).

            Patients with diabetes mellitus (DM) have infections more often than those without DM. The course of the infections is also more complicated in this patient group. One of the possible causes of this increased prevalence of infections is defects in immunity. Besides some decreased cellular responses in vitro, no disturbances in adaptive immunity in diabetic patients have been described. Different disturbances (low complement factor 4, decreased cytokine response after stimulation) in humoral innate immunity have been described in diabetic patients. However, the clinical relevance of these findings is not clear. Concerning cellular innate immunity most studies show decreased functions (chemotaxis, phagocytosis, killing) of diabetic polymorphonuclear cells and diabetic monocytes/macrophages compared to cells of controls. In general, a better regulation of the DM leads to an improvement of these cellular functions. Furthermore, some microorganisms become more virulent in a high glucose environment. Another mechanism which can lead to the increased prevalence of infections in diabetic patients is an increased adherence of microorganisms to diabetic compared to nondiabetic cells. This has been described for Candida albicans. Possibly the carbohydrate composition of the receptor plays a role in this phenomenon.
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              Pharmacokinetics and dosage adjustment in patients with hepatic dysfunction.

              The liver plays a central role in the pharmacokinetics of the majority of drugs. Liver dysfunction may not only reduce the blood/plasma clearance of drugs eliminated by hepatic metabolism or biliary excretion, it can also affect plasma protein binding, which in turn could influence the processes of distribution and elimination. Portal-systemic shunting, which is common in advanced liver cirrhosis, may substantially decrease the presystemic elimination (i.e., first-pass effect) of high extraction drugs following their oral administration, thus leading to a significant increase in the extent of absorption. Chronic liver diseases are associated with variable and non-uniform reductions in drug-metabolizing activities. For example, the activity of the various CYP450 enzymes seems to be differentially affected in patients with cirrhosis. Glucuronidation is often considered to be affected to a lesser extent than CYP450-mediated reactions in mild to moderate cirrhosis but can also be substantially impaired in patients with advanced cirrhosis. Patients with advanced cirrhosis often have impaired renal function and dose adjustment may, therefore, also be necessary for drugs eliminated by renal exctretion. In addition, patients with liver cirrhosis are more sensitive to the central adverse effects of opioid analgesics and the renal adverse effects of NSAIDs. In contrast, a decreased therapeutic effect has been noted in cirrhotic patients with beta-adrenoceptor antagonists and certain diuretics. Unfortunately, there is no simple endogenous marker to predict hepatic function with respect to the elimination capacity of specific drugs. Several quantitative liver tests that measure the elimination of marker substrates such as galactose, sorbitol, antipyrine, caffeine, erythromycin, and midazolam, have been developed and evaluated, but no single test has gained widespread clinical use to adjust dosage regimens for drugs in patients with hepatic dysfunction. The semi-quantitative Child-Pugh score is frequently used to assess the severity of liver function impairment, but only offers the clinician rough guidance for dosage adjustment because it lacks the sensitivity to quantitate the specific ability of the liver to metabolize individual drugs. The recommendations of the Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) to study the effect of liver disease on the pharmacokinetics of drugs under development is clearly aimed at generating, if possible, specific dosage recommendations for patients with hepatic dysfunction. However, the limitations of the Child-Pugh score are acknowledged, and further research is needed to develop more sensitive liver function tests to guide drug dosage adjustment in patients with hepatic dysfunction.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: MethodologyRole: Writing – review & editing
                Role: ConceptualizationRole: MethodologyRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: MethodologyRole: Writing – original draftRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                22 March 2018
                2018
                : 13
                : 3
                : e0194553
                Affiliations
                [1 ] Department of Anesthesiology, Stony Brook University, Stony Brook, NY, United States of America
                [2 ] Health Economics and Outcomes Research, Medtronic, Mansfield, MA, United States of America
                [3 ] Department of Anesthesiology, Roper St Francis Health System, Charleston, SC, United States of America
                [4 ] Respiratory, Gastrointestinal & Informatics, Medtronic, Boulder, CO, United States of America
                Harvard Medical School, UNITED STATES
                Author notes

                Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: This analysis was supported by Medtronic Healthcare Economics and Outcomes Research. JQ and ME are Medtronic employees. II and TJG received grant support for this study. FJO reports grant support and honorarium from Medtronic, unrelated to the submitted work. There are no patents, products in development or marketed products to declare. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials.

                Author information
                http://orcid.org/0000-0001-5506-398X
                Article
                PONE-D-17-30035
                10.1371/journal.pone.0194553
                5864099
                29566020
                be02d3a7-bda2-4226-83b1-49716a3a4149
                © 2018 Izrailtyan et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 14 August 2017
                : 6 March 2018
                Page count
                Figures: 0, Tables: 3, Pages: 13
                Funding
                This analysis was supported by Medtronic Healthcare Economics and Outcome Research. JQ and ME are Medtronic employees. The funder, Medtronic, provided support in the form of salaries for authors JQ and ME, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the "author contributions" section.
                Categories
                Research Article
                Medicine and Health Sciences
                Pharmacology
                Drugs
                Analgesics
                Opioids
                Medicine and Health Sciences
                Pain Management
                Analgesics
                Opioids
                Medicine and Health Sciences
                Pharmacology
                Drugs
                Opioids
                Medicine and Health Sciences
                Pharmacology
                Drugs
                Sedatives
                Medicine and Health Sciences
                Surgical and Invasive Medical Procedures
                Medicine and Health Sciences
                Cardiology
                Medicine and Health Sciences
                Pulmonology
                Chronic Obstructive Pulmonary Disease
                Medicine and Health Sciences
                Gastroenterology and Hepatology
                Liver Diseases
                Medicine and Health Sciences
                Pulmonology
                Medicine and Health Sciences
                Health Care
                Patients
                Inpatients
                Custom metadata
                All relevant data are within the paper and its Supporting Information files.

                Uncategorized
                Uncategorized

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