2024 ACCP Virtual Journal Club Webinar-March | Edoxaban Exposure in Patients With Atrial Fibrillation and Estimated Creatinine Clearance Exceeding 100 mL/min-LIVE
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2024 ACCP Virtual Journal Club Webinar: Edoxaban Exposure in Patients with Atrial Fibrillation and Estimated Creatinine Clearance Exceeding 100 mL/min - LIVE
Live Session: Wednesday, March 20th, 2024, from 2:00 to 3:00 PM ET
On Demand: March 20th, 2024 to March 20th, 2027
Why is this article important to your practice?
There is a lack of clear understanding of high creatinine clearance on pharmacokinetic/pharmacodynamic (PK/PD) outcomes. Edoxaban 60 mg is approved for stroke prevention in patients with atrial fibrillation (AF) not fulfilling any dose-reduction criteria. As edoxaban is partially renally cleared (≈50%), it was postulated that edoxaban exposure may be lower in patients with high creatinine clearance (CrCL >100 mL/min); thus, efficacy could hypothetically be lower in this subpopulation. In this webinar, the author will discuss a prospective, randomized, double-blinded study comparing the pharmacokinetics, pharmacodynamics, efficacy and safety outcomes of edoxaban 60 mg once daily versus edoxaban 75 mg once daily in patients with CrCL exceeding 100 mL/min. The presentation will also illustrate the utility of population PK modeling to account for variability and estimate steady-state PK values based on the sparse PK concentrations collected in the study.
Target Audience:
Interprofessional team of Physicians, Pharmacists, PhDs, and other health care professionals.
Learning Objectives
After completing this activity, the learner will be able to:
- Describe the impact of high creatinine clearance on edoxaban PK and PD and the potential clinical implications;
- Recognize the utility of population PK modeling in analyzing sparse PK concentrations collected from clinical studies;
- Describe the key elements of a prospective, randomized, placebo-controlled clinical trial.
Ophelia Yin
Vice President, Head of Clinical Pharmacology
iTeos Therapeutics
Ophelia Yin is currently Vice President, Head of Clinical Pharmacology at iTeos Therapeutics. Ophelia’s career began as Assistant Professor at the Pharmacy School of Chinese University of Hong Kong. She joined Novartis Oncology 2005, serving as the global clinical pharmacology expert to support oncology drug development. From 2012 to 2020, Ophelia was Executive Director and Head of Advanced Pharmacometrics at the Quantitative Clinical Pharmacology Department of Daiichi Sankyo. Her work included development and execution of quantitative clinical pharmacology plans, and use of state-of-the-art pharmacometrics methods to contribute to key decision making at all stages of clinical development across a variety of therapeutic areas, including oncology, cardiovascular and metabolic disease. From 2021 to May 2023, Ophelia was Head of Pharmacometrics at Agios Pharmaceuticals, providing strategic leadership and subject matter expertise to support research and development activities in genetically defined diseases.
Ophelia earned a PhD in Pharmaceutics from Shanghai Medical University. She has published over 90 abstracts, 80 peer-reviewed articles, and 2 book chapters in the field of clinical pharmacology and pharmacometrics. Ophelia is a Fellow of American College of Clinical Pharmacology, and a member of editorial board of Journal of Clinical Pharmacology.
Dr. Yin is an employee of iTeos Therapeutics. All of the relevant financial relationships for this individual have been mitigated
Stefanie Drescher
Manager, Clinical Pharmacology
Pfizer Inc
Dr. Stafanie Drescher is an accomplished Pharmacist, Quantitative Clinical Pharmacologist, and Clinical Pharmacology Leader with over 8 years of comprehensive experience in Translational Medicine & Early Clinical Development working in the biopharmaceutical sector, regulatory bodies (U.S. Food and Drug Administration), and academia. Actively promoting the implementation of model-informed drug development (MIDD) principles to ensure swift and effective transition of new therapeutics from the laboratory to the patient's bedside. Regularly collaborate within multidisciplinary teams on innovative early-stage oncology programs.
Experienced across all stages of drug development, encompassing the design, management, and analysis of both preclinical and clinical studies, such as xenograft and syngeneic tumor models, first-in-human investigations in healthy volunteers and cancer patients (Phase I/II trials), clinical DDI, relative BA, BE, IVIVC, food effect, special populations, and QTc. Broad therapeutic knowledge in infectious diseases, oncology, and respiratory diseases.
Stefanie Drescher is an employee of Pfizer Inc. All of the relevant financial relationships for this individual have been mitigated.
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