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In this article, we review the history and key reasons for new-user comparisons in pharmacoepidemiology, highlighting the target trial framework as a unifying framework. We describe three distinct pharmacoepidemiological new-user study designs: (1) new-user versus non-user; (2) active comparator new-user; (i.e., ACNU) and (3) prevalent new-user (i.e., PNU) designs, and discuss how each relates to key issues of defining time zero, choosing appropriate comparator groups, and potential sources of bias they do and do not account for. We use a clinical example of hormone replacement therapy and the risk of coronary heart disease to illustrate practical considerations surrounding the application of the three designs presented.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11588434 | PMC |
http://dx.doi.org/10.1002/pds.70048 | DOI Listing |
Am J Cardiol
September 2025
Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark; Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Background: While trial evidence supports the benefit of angiotensin receptor-neprilysin inhibitor (ARNI) therapy in heart failure with reduced ejection fraction (HFrEF), its effectiveness in routine clinical practice is less explored. This study investigated the relative and absolute effectiveness of ARNI in patients with HFrEF.
Methods: This nationwide Danish database study included patients with left ventricular ejection fraction (LVEF) ≤40%, 2018-2023.
Bone
September 2025
Department of Health Data Science, Graduate School of Medicine, Tokyo Medical University, Shinjuku-ku, Tokyo, Japan.
Stud Health Technol Inform
September 2025
Goethe University Frankfurt, University Medicine, Institute of Medical Informatics (IMI), Frankfurt am Main, Germany.
Introduction: An audit trail is of critical importance for patient registries and electronic data capture (EDC) systems, as it ensures transparency, integrity, traceability and security of the collected data. This work demonstrates the development and usability evaluation of an initial prototype of an accessible audit trail for the Open Source Registry System for Rare Diseases (OSSE), an open source software tool for building patient registries.
Methods: The prototype comprises a new user interface with list views and detailed views to make the information stored in the audit trail of the OSSE EDC database available for users.
Thorax
August 2025
Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan.
Introduction: Despite warnings from the US Food and Drug Administration about respiratory adverse events associated with gabapentinoids, direct evidence of their risk in patients with asthma is lacking.
Methods: Using a national administrative claims database, we prepared two active comparators-new user cohorts of patients with a history of neuropathic or chronic pain and asthma-initiating gabapentinoids and comparator drugs (tricyclic antidepressants (TCAs) or serotonin norepinephrine reuptake inhibitors (SNRIs)). Overlap propensity score weighting was used to control for potential confounders.
J Intern Med
August 2025
School of Pharmacy, Sungkyunkwan University, Suwon, South Korea.
Background: Type 2 diabetes mellitus (T2DM) and gout are associated with an increased risk of cardiovascular events. Despite the approval for the secondary prevention of cardiovascular diseases by the United States Food and Drug Administration in 2023, evidence regarding the effectiveness of colchicine among T2DM population remains limited.
Objectives: We aimed to evaluate the association between the use of colchicine and the risk of major adverse cardiovascular events (MACE) among patients with gout and T2DM.