Assessing QTc Effects of Vericiguat Using Two Different Concentration-QTc Modeling Approaches

Author:

Ruehs HaukeORCID,Solms AlexanderORCID,Frei Matthias,Becker CorinaORCID,Trujillo Maria E.ORCID,Garmann Dirk,Meyer MichaelaORCID

Funder

Bayer AG, Berlin, Germany

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference11 articles.

1. Food and Drug Administration. VerquvoTM (vericiguat) tablets. Highlights of prescribing information. 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214377s000lbl.pdf. Accessed 11 May 2022.

2. Bayer plc. Verquvo 10 mg film-coated tablets Summary of Product Characteristics. 2021. https://www.medicines.org.uk/emc/product/12775/smpc#gref. Accessed 27 Aug 2021.

3. Armstrong PW, Pieske B, Anstrom KJ, Ezekowitz J, Hernandez AF, Butler J, et al. Vericiguat in patients with heart failure and reduced ejection fraction. N Engl J Med. 2020;382(20):1883–93.

4. European Medicines Agency. ICH topic E 14. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. 2005. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-14-clinical-evaluation-qt/qts-interval-prolongation-proarrhythmic-potential-non-antiarrhythmic-drugs-step-5_en.pdf. Accessed 1 Dec 2022.

5. European Medicines Agency. ICH guideline E14/S7B on clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential- questions & answers. 2020. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-e14/s7b-clinical-nonclinical-evaluation-qt/qtc-interval-prolongation-proarrhythmic-potential-questions-answers-step-2b_en.pdf. Accessed 1 Dec 2022.

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