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Which clinical trial designs and statistical approaches have been used in assessments of orphan maintenance by the European Medicines Agency between 2012 and 2022? A cross-sectional study.
BMJ Open
December 2024
European Medicines Agency, Amsterdam, The Netherlands
Objectives: In the European Union, a new orphan medicinal product must demonstrate 'significant benefit' over approved medicinal products targeting the same indication. To demonstrate a significant benefit, comparisons between the new product and the already approved medicinal products-either directly by a head-to-head comparison within a clinical trial or indirectly as a cross-trial comparison-are necessary. In this study, we investigate the types of trial designs and statistical approaches used for demonstrating a significant benefit of a new orphan medicinal product against approved comparators used between 2012 and 2022.
View Article and Find Full Text PDFGWAS of CRP response to statins further supports the role of APOE in Statin Response: a GIST consortium study.
Pharmacol Res
January 2025
Centre of Clinical Pharmacology & Precision Medicine, William Harvey Research Institute, Queen Mary University of London, London, UK; NIHR Barts Biomedical Research Centre, Queen Mary University of London, London, UK. Electronic address:
Article Synopsis
- Statins are key medications used to prevent cardiovascular disease by not only lowering lipids but also reducing inflammation, measured by C-reactive protein (CRP).
- Two significant genetic loci linked to how individuals respond to statin treatment in terms of changes in CRP levels were identified: APOE and HNF1A, both of which are associated with various health conditions like coronary artery disease and diabetes.
- Further analysis suggests that the APOE-E4 variant may influence the effectiveness of statins, hinting at its potential role in personalized healthcare for those with cardiovascular and related conditions.
Signaling Dynamics in Osteogenesis: Unraveling Therapeutic Targets for Bone Generation.
Curr Drug Targets
January 2025
Department of Molecular Medicine, The Herbert Wertheim UF Scripps Institute for Biomedical Innovation & Technology, Jupiter, FL33458, United States.
Diseases affecting bone encompass a spectrum of disorders, from prevalent conditions such as osteoporosis and Paget's disease, collectively impacting millions, to rare genetic disorders including Fibrodysplasia Ossificans Progressiva (FOP). While several classes of drugs, such as bisphosphonates, synthetic hormones, and antibodies, are utilized in the treatment of bone diseases, their efficacy is often curtailed by issues of tolerability and high incidence of adverse effects. Developing therapeutic agents for bone diseases is hampered by the fact that numerous pathways regulating bone metabolism also perform pivotal functions in other organ systems.
View Article and Find Full Text PDFRacecadotril in the management of diarrhea: an underestimated therapeutic option?
Therap Adv Gastroenterol
January 2025
Operative Unit of Clinical Pharmacology and Pharmacovigilance, Renato Dulbecco University Hospital, Catanzaro, Italy.
Acute infectious diarrhea (AID) represents an important clinical entity both regarding morbidity and mortality rates, even in industrialized countries, and it leads to one of the major public health burdens, among gastroenterological diseases, with significant healthcare costs. Oral rehydration solution is the cornerstone of the therapy, but despite its proven efficacy in avoiding dehydration, it is still underused as it does not reduce the duration of diarrhea; hence, it is perceived as ineffective by caregivers. In this narrative review, we collected literature regarding the use of racecadotril, deeply discussing its role in the treatment of AID in both adults and children.
View Article and Find Full Text PDFIncorporating immune checkpoint inhibitors in epithelial ovarian cancer.
Gynecol Oncol
January 2025
GOG Foundation, Florida Cancer Specialists and Research Institute, West Palm Beach, FL 33401, United States of America. Electronic address:
Objective: Therapeutic interventions for epithelial ovarian cancer (EOC) have increased greatly over the last decade but improvements outside of biomarker selected therapies have been limited. There remains a pressing need for more effective treatment options that can prolong survival and enhance the quality of life of patients with EOC. In contrast to the significant benefits of immunotherapy with immune checkpoint inhibitors (CPI) seen in many solid tumors, initial experience in EOC suggests limited efficacy of CPIs monotherapy.
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