Most literature describing pharmacogenetic implementations are within academic medical centers and use single-gene tests. Our objective was to describe the results and lessons learned from a multisite pharmacogenetic pilot that utilized panel-based testing in academic and nonacademic settings. This was a retrospective analysis of 667 patients from a pilot in 4 perioperative and 5 outpatient cardiology clinics. Recommendations related to 12 genes and 65 drugs were classified as actionable or not actionable. They were ascertained from Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines and US Food and Drug Administration (FDA) labeling. Patients displayed a high prevalence of actionable results (88%, 99%) and use of medications (28%, 46%) with FDA or CPIC recommendations, respectively. Sixteen percent of patients had an actionable result for a current medication per CPIC compared with 5% per FDA labeling. A systematic approach by a health system may be beneficial given the quantity and diversity of patients affected.
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http://dx.doi.org/10.1111/cts.12748 | DOI Listing |
Bioorg Med Chem
January 2025
Division of Nuclear Medicine, Department of Radiology, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand. Electronic address:
Technetium-99m (Tc-99m) is the most employed radionuclide in nuclear imaging diagnostics worldwide for many diseases. The ideal physiochemical properties of Tc-99m (such as half-life and pure gamma energy) make it favorable for Single Photon Emission Computed Tomography (SPECT). In this study, we aim to expand the utilization of Tc-99m radiopharmaceutical toward prostate cancer diagnostics which is currently no FDA approved products and has been intensively examined for a potential candidate.
View Article and Find Full Text PDFCancer Chemother Pharmacol
January 2025
Clinical Pharmacology and Translational Sciences, Pfizer Worldwide R&D, 10555 Science Center Drive, San Diego, CA, 92121, USA.
As development of new oncology small molecule therapies is focused mainly on molecularly targeted agents, the dose selection paradigm has shifted from the maximum tolerated dose (MTD)-based approach traditionally utilized with cytotoxic drugs towards determining an optimal dose with long-term tolerability while maintaining efficacy. To assess overall tolerability in recently approved oncology small molecules, we surveyed 54 compounds approved by the FDA since March 2017 with respect to dose intensity, dose modifications, and treatment emergent adverse events (TEAEs). Of the 54 new molecular entities surveyed, only 15 were approved at a label dose equal to the MTD (Label Dose = MTD).
View Article and Find Full Text PDFAnn Otol Rhinol Laryngol
January 2025
Department of Otolaryngology-Head and Neck Surgery, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.
Objectives: The primary objective of this case series is to assess the effectiveness of the off-label use of the PROPEL drug-eluting stent, traditionally FDA-approved for sinus surgery, in preventing restenosis following canalplasty in patients with chronic otologic conditions or congenital anomalies. The stent provides both mechanical support to maintain canal patency and localized steroid delivery to reduce inflammation and scarring.
Methods: Four patients with various otologic conditions underwent canalplasty, followed by the placement of drug-eluting stents into the external auditory canal.
Dermatol Ther (Heidelb)
January 2025
Department of Dermatology, Emory University School of Medicine, 1525 Clifton Road NE, Atlanta, GA, 30322, USA.
Introduction: Acne impairs quality of life, often leads to permanent scars, and causes psychological distress. This review aims to update dermatologists on the Federal Drug Administration (FDA)-approved and off-label use of combined oral contraceptives (COC), clascoterone, spironolactone, and emerging hormonal therapies for acne treatment.
Methods: We reviewed current literature on hormonal acne treatments and discussed common patient concerns, barriers to care, and individualized care needs.
Alzheimers Dement
December 2024
Department of Neurology, Mayo Clinic, Rochester, MN, USA.
Background: While disease-modifying treatments that reduce Aβ have been recently approved by the FDA, the identification of novel therapeutic targets and strategies that target underlying mechanisms to delay the AD development are still needed. Abnormal brain energy homeostasis and mitochondria dysfunction are observed early in AD. Therefore, the development of treatments to restore these defects could be beneficial.
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