Edeltraut Garbe

Framework for Exploration of Statistical Heterogeneity in Multi-Database Studies: A Case Study Using EXACOS-CV Studies

Kirsty Rhodes, Edeltraut Garbe, Hana Müllerová, Nils Kossack et autres

Purpose: Multi-database studies may provide heterogeneous results despite using common protocols, leading to challenges in interpretation, but also providing an opportunity to gain insights on populations or healthcare systems. The objectives of these analyses were to develop a framework for exploring sources …

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Long-Term Safety of Roflumilast in Patients with Chronic Obstructive Pulmonary Disease, a Multinational Observational Database Cohort Study

Edeltraut Garbe, Fabian Hoti, Tania Schink, Kristian Svendsen et autres

Purpose: This study evaluated the long-term safety of roflumilast in patients with chronic obstructive pulmonary disease or chronic bronchitis using electronic healthcare databases from Germany, Norway, Sweden, and the United States (US). Patients and Methods: The study population consisted of patients aged …

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Elucidating the risk of cardiopulmonary consequences of an exacerbation of COPD: results of the EXACOS-CV study in Germany

Claus Vogelmeier, Kirsty Rhodes, Edeltraut Garbe, Melanie Abram et autres

BACKGROUND: Exacerbations of chronic obstructive pulmonary disease (COPD) represent a period of vulnerability. This study explored the association between time periods following an exacerbation and the risk of severe cardiovascular (CV) events or death in Germany. METHODS: A longitudinal cohort study was …

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Risk of cardiovascular events after an exacerbation of chronic obstructive pulmonary disease: results from the EXACOS-CV cohort study using the PHARMO Data Network in the Netherlands

Karin M. A. Swart, Brenda N Baak, Louise Lemmens, Fernie J. A. Penning‐van Beest et autres

BACKGROUND: People living with chronic obstructive pulmonary disease (COPD) have an increased risk of experiencing cardiovascular (CV) events, particularly after an exacerbation. Such CV burden is not yet known for incident COPD patients. We examined the risk of severe CV events in …

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Increased risk of decompensated heart failure, acute coronary syndrome, arrythmias and ischemic stroke following exacerbation of COPD: results from a multi-database cohort study

Nathaniel M. Hawkins, Claus Vogelmeier, Sami O. Simons, Edeltraut Garbe et autres

Abstract Introduction The risk of acute coronary syndrome (ACS), stroke or death is increased following an exacerbation of chronic obstructive pulmonary disease (COPD). However, little is known about the risk of decompensated heart failure (HF) or acute arrhythmias. Purpose To quantify the …

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Increased risk of severe cardiovascular events following exacerbations of COPD: a multi-database cohort study

Claus Vogelmeier, Sami O. Simons, Edeltraut Garbe, Don D. Sin et autres

Introduction: Risk of severe cardiovascular events (CVE) increases following severe exacerbations of COPD (ECOPD). However, the duration of increased risk and the effect of moderate ECOPD are unclear. Objective: To quantify risk of a severe CVE or death following a moderate or …

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EXAcerbations of COPD and their OutcomeS on CardioVascular diseases (EXACOS-CV) Programme: protocol of multicountry observational cohort studies

Clémentine Nordon, Kirsty Rhodes, Jennifer K Quint, Claus Vogelmeier et autres

INTRODUCTION: In patients with chronic obstructive pulmonary disease (COPD), the risk of certain cardiovascular (CV) events is increased by threefold to fivefold in the year following acute exacerbation of COPD (AECOPD), compared with a non-exacerbation period. While the effect of severe AECOPD …

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Pharmacoepidemiology

Edeltraut Garbe, Samy Suissa, Antonios Douros

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Wissenschaftliche Begründung der STIKO zur Aktualisierung der Empfehlung der COVID-19-Auffrischimpfung mit einem mRNA-Impfstoff

Judith Koch, Sabine Vygen-Bonnet, Christian Bogdan, Gerd Burchard et autres

Wissenschaftliche Begründung der STIKO zur Empfehlung, im Alter unter 30 Jahren ausschließlich Comirnaty zur COVID-19-Grundimmunisierung und -Auffrischimpfung zu verwenden

Judith Koch, Sabine Vygen-Bonnet, Christian Bogdan, Gerd Burchard et autres

Seit dem Frühjahr 2021 ist bekannt, dass im Zusammenhang mit der Anwendung der mRNA-Impfstoffe Comirnaty und Spikevax insbesondere bei Jungen und jungen Männern Myo- und/oder Perikarditiden auftreten können. Aufgrund dieser Berichte hat die STIKO ihre Empfehlung zur COVID-19-Impfung mit Spikevax und Comirnaty …

Cardiovascular Risk in Users of Mirabegron Compared with Users of Antimuscarinic Treatments for Overactive Bladder: Findings from a Non-Interventional, Multinational, Cohort Study

Veena Hoffman, Jesper Hallas, Marie Linder, Andrea V. Margulis et autres

During clinical trials, mirabegron, a β3-adrenoreceptor agonist, was associated with increased vital signs vs placebo in patients with overactive bladder. The purpose of this study was to compare incidence rates of adverse cardiovascular (CV) outcomes following mirabegron or antimuscarinic use. We conducted …

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Use of intravenous iron and risk of anaphylaxis: A multinational observational post‐authorisation safety study in Europe

Joan Fortuny, Gero von Gersdorff, R. Lassalle, Marie Linder et autres

PURPOSE: This post-authorisation safety study estimated the risk of anaphylaxis in patients receiving intravenous (IV) iron in Europe, with interest in iron dextran and iron non-dextrans. Studies conducted in the United States have reported risk of anaphylaxis to IV iron ranging from …

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