ADV is frequently seen in our pediatric SOT population. It presents in a variety of clinical presentation and can cause severe disease. In this population, there are very few studies to determine the safety of CDV as a potential therapeutic agent. We present the findings of our retrospective study evaluating the efficacy and safety of CDV as 2 separate dosing regimens. Regimen A uses the standard 5 mg/kg once a week (Regimen A), and the second uses the 1 mg/kg 3 times per week (Regimen B). Overall, the dosing regimen did not differ in nephrotoxicity, but Regimen B had a higher, although non-significant, rate of viral load clearance. This suggests that more frequent dosing at lower levels may be more efficacious without any significant side effects in our SOT population.
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http://dx.doi.org/10.1111/petr.13231 | DOI Listing |
Eur J Pharm Sci
January 2025
Department of Pharmacy, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China; Department of Pharmacy, National Regional Medical Center, Binhai Campus of the First Affiliated Hospital, Fujian Medical University, Fuzhou, China. Electronic address:
Tacrolimus is extensively used for the prevention of graft rejection following solid organ transplantation in pregnant women. However, knowledge gaps in the dosage of tacrolimus for pregnant patients with different CYP3A5 genotypes and infection conditions have been identified. This study aimed to develop a pregnant physiologically based pharmacokinetic (PBPK) model to characterize the maternal and fetal pharmacokinetics of tacrolimus during pregnancy and explore and provide dosage adjustments.
View Article and Find Full Text PDFDrug Metab Pharmacokinet
November 2024
Clinical Research, Drug Development Division, Sumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka, 564-0053, Japan. Electronic address:
The second-generation antipsychotic blonanserin is a highly selective, full antagonist of dopamine D and D and serotonin 5-HT receptors. It is currently prescribed for patients with schizophrenia in Japan. We aimed to develop a population pharmacokinetic model of oral blonanserin, including data from 12 to 77 years old patients, to assess the covariates that influence blonanserin pharmacokinetics and evaluate appropriate dosage regimens in adolescents versus adults.
View Article and Find Full Text PDFAllergy
January 2025
St John's Institute of Dermatology, Guy's Hospital, London, UK.
Background: This study compared the therapeutic equivalence of CT-P39 (an omalizumab biosimilar) and EU-approved reference omalizumab (ref-OMA) in patients with chronic spontaneous urticaria.
Methods: This double-blind, randomized, active-controlled Phase 3 study (NCT04426890) included two 12-week treatment periods (TPs). In TP1, patients received CT-P39 300 mg, ref-OMA 300 mg, CT-P39 150 mg, or ref-OMA 150 mg.
Cochrane Database Syst Rev
January 2025
Institute of Education in Healthcare and Medical Sciences, University of Aberdeen, Aberdeen, UK.
Background: Gonadotropin-releasing hormone agonists (GnRHa) are commonly used in assisted reproduction technology (ART) cycles to prevent a luteinising hormone (LH) surge during controlled ovarian hyperstimulation (COH) prior to planned oocyte retrieval, thus optimising the chances of live birth. We compared the benefits and risks of the different GnRHa protocols used.
Objectives: To evaluate the effectiveness and safety of different GnRHa protocols used as adjuncts to COH in women undergoing ART.
Background: Lecanemab is a humanized IgG1 monoclonal antibody that binds with high affinity to Aβ soluble protofibrils. In two clinical studies (phase 2, NCT01767311 and phase 3 ClarityAD, NCT03887455) in early Alzheimer's disease, lecanemab substantially reduced amyloid PET and significantly slowed clinical decline on multiple measures of cognition and function, including CDR-SB at 18 months. Models describing the change in amyloid PET and CDR-SB in response to lecanemab treatment were used to explore the impact of changing from the initial dosage regimen (10 mg/kg every 2 weeks [Q2W]) to a less intensive maintenance dosing regimen (10 mg/kg every 4 weeks [Q4W]) on clinical efficacy, and to explore the optimal duration of the initial dosing regimen.
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