Purpose: Guidelines recommend low-molecular-weight heparins (LMWHs) for patients with cancer-associated thrombosis. However, until recently, only dalteparin and tinzaparin were approved in the European Economic Area (EEA) for these patients. This study compares the benefit-risk profile of enoxaparin with dalteparin and tinzaparin for the extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrence in adult patients with active cancer.
Methods: A semi-quantitative structured benefit-risk assessment was conducted for the label-extension application of enoxaparin based on the benefit-risk action team descriptive framework: define decision context; determine key benefit and risk outcomes; identify data sources; extract data; interpret results.
Results: The key benefits were defined as reduced all-cause mortality and venous thromboembolism (VTE) recurrence (including symptomatic DVT, fatal PE or non-fatal PE); the key risks were major and non-major bleeding of clinical significance, and heparin-induced thrombocytopenia (HIT). Enoxaparin demonstrated comparable effects for the reduction of VTE recurrence and all-cause mortality versus other EEA-approved LMWHs (dalteparin, tinzaparin). There was no evidence of a significant difference between enoxaparin and the comparator groups with regard to incidence of major and non-major bleeding. The data on HIT were too limited to assess the difference between the two groups.
Conclusions: The assessment demonstrated a favourable benefit-risk profile for enoxaparin similar to that of other EEA-approved LMWHs for the treatment of DVT and PE and the prevention of recurrence in patients with active cancer and thus supported the label-extension approval.
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http://dx.doi.org/10.1002/pds.5795 | DOI Listing |
Int J Infect Dis
January 2025
Victorian Infectious Diseases Service, Royal Melbourne Hospital, Melbourne, VIC, Australia; Department of Infectious Diseases and National Center for Infection, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; National Centre for Infections in Cancer, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, The University of Melbourne, VIC, Australia.
Objectives: We aimed to describe the characteristics of Clostridioides difficile infection (CDI) in cancer patients, analysing risk factors for 90-day recurrence and attributable mortality.
Methods: Retrospective analysis on all CDI episodes from 2020 to 2022 in three Australian hospitals and one Spanish hospital. Logistic regression analyses were performed.
Lancet Diabetes Endocrinol
January 2025
British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK. Electronic address:
Background: Data on the effect of mineralocorticoid receptor antagonist therapy on HbA levels and new-onset diabetes are conflicting. We aimed to examine the effect of oral finerenone, compared with placebo, on incident diabetes in the Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure (FINEARTS-HF) trial.
Methods: In this randomised, double-blind, placebo-controlled trial, 6001 participants with heart failure with New York Heart Association functional class II-IV, left ventricular ejection fraction 40% or higher, evidence of structural heart disease, and elevated N-terminal pro-B-type natriuretic peptide levels were randomly assigned to finerenone or placebo, administered orally.
Lancet Infect Dis
January 2025
Institut Pasteur, Université Paris Cité, G5 Épidémiologie et Analyse des Maladies Infectieuses, Paris, France. Electronic address:
Background: Plasmodium vivax forms dormant liver stages (hypnozoites) that can reactivate weeks to months after primary infection. Radical cure requires a combination of antimalarial drugs to kill both the blood-stage and liver-stage parasites. Hypnozoiticidal efficacy of the liver-stage drugs primaquine and tafenoquine cannot be estimated directly because hypnozoites are undetectable.
View Article and Find Full Text PDFJ Reprod Immunol
January 2025
Graduate School of Economics, Nagoya City University, Japan.
Sporadic early miscarriages occur primarily due to embryonic aneuploidy. There is no evidence showing that stress is a direct cause of miscarriage. Yet, despite this, a national US survey and a Japanese survey found that many people mistakenly attributed miscarriage to the mental state or behavior of the women.
View Article and Find Full Text PDFRes Nurs Health
January 2025
School of Nursing and Health, Zhengzhou University, Zhengzhou, Henan, China.
Behavioral management is essential to preventing recurrence after stroke, but its adherence is limited worldwide. We aimed to assess the impact of the behavior intervention based on the Recurrence risk perception and Behavioral decision Model for ischemic stroke patients' health behavior. This study was a single-blind, randomized, controlled trial with a 3-month follow-up.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!