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Sequential Epidemiological Analyses of Real-World Data: A Tool for Prospective Drug Safety Surveillance from the Rofecoxib Example.
Drug Saf
January 2025
Clinical Pharmacology, Pharmacy and Environmental Medicine, Department of Public Health, University of Southern Denmark, 5000, Odense C, Denmark.
Introduction: Large administrative healthcare databases can be used for near real-time sequential safety surveillance of drugs as an alternative approach to traditional reporting-based pharmacovigilance. The study aims to build and empirically test a prospective drug safety monitoring setup and perform a sequential safety monitoring of rofecoxib use and risk of cardiovascular outcomes.
Methods: We used Danish population-based health registers and performed sequential analysis of rofecoxib use and cardiovascular outcomes using case-time-control and cohort study designs from January 2000 to September 2004.
Effect of Ozoralizumab Administration with or without Methotrexate in Patients with Rheumatoid Arthritis: A Post-Hoc Analysis.
Rheumatol Ther
January 2025
Saitama Medical University, 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan.
Introduction: Ozoralizumab (OZR) is a novel tumor necrosis factor (TNF) inhibitor that was launched in Japan for treating patients with rheumatoid arthritis (RA) who have had an inadequate response to existing therapies. This post-hoc analysis aimed to compare the efficacy of OZR administered without methotrexate (MTX) with placebo or OZR administration in combination with MTX.
Methods: We analyzed the OZR group (30 mg) in the NATSUZORA trial (non-MTX, open trial) (OZR group; n = 94) and the placebo group (MTX group; n = 75) and the 30-mg OZR group (OZR + MTX group; n = 152) in the OHZORA trial (combined MTX, double-blind trial), and the covariates were adjusted by propensity score matching.
Retrospective Cohort Study of Elderly Users of Single- or Multiple-Inhaler Triple Therapy for the Treatment of Asthma in the USA.
Pulm Ther
January 2025
US Medical Affairs, GSK, ATC Fowler Building, 410 Blackwell Street, Durham, NC, 27701, USA.
Introduction: Escalation to single- or multiple-inhaler triple therapy (SITT; MITT) is a recommended option for patients with asthma who remain uncontrolled by medium-dose inhaled corticosteroid/long-acting β-agonist; however, characterization of elderly users of triple therapy is limited. This real-world cohort study describes demographics and clinical characteristics of elderly patients with asthma with and without comorbid chronic obstructive pulmonary disease (COPD) who are new users of triple therapy, and asthma treatment patterns preceding triple therapy initiation.
Methods: This retrospective cohort study used administrative claims data from the Optum Clinformatics Data Mart database.
Intraspecific identification and genetic diversity analysis of Paeonia lactiflora based on chloroplast genes rpoB and psbK-psbI.
Mol Biol Rep
January 2025
School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, 102488, People's Republic of China.
Background: Paeonia lactiflora Pall., a member of Paeoniaceae family, is a medicinal herb widely used in traditional Chinese medicine. Chloroplasts are multifunctional organelles containing distinct genetic material.
View Article and Find Full Text PDFHow do we measure the costs, benefits, and harms of sharing data from biomedical studies? A protocol for a scoping review.
Open Res Eur
January 2025
Heidelberger Institut für Global Health, Universitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg, 69120, Germany.
Introduction: The benefits of sharing participant-level data, including clinical or epidemiological data, genomic data, high-dimensional imaging data, or human-derived samples, from biomedical studies have been widely touted and may be taken for granted. As investments in data sharing and reuse efforts continue to grow, understanding the cost and positive and negative effects of data sharing for research participants, the general public, individual researchers, research and development, clinical practice, and public health is of growing importance. In this scoping review, we will identify and summarize existing evidence on the positive and negative impacts and costs of data sharing and how they are measured.
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