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Pharmacodynamic and Pharmacokinetic Interaction Profile of Vericiguat: Results from Three Randomized Phase I Studies in Healthy Volunteers by Michael Boettcher; Stephanie Loewen; Mireille Gerrits; Corina Becker is a Medicine article available to read on EtoBox.

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## Background Vericiguat, a direct stimulator of soluble guanylate cyclase, has been developed as a first-in-class therapy for symptomatic chronic heart failure (HF) and ejection fraction < 45%. ## Methods Safety, pharmacodynamic (PD), and pharmacokinetic (PK) interactions between vericiguat and drugs used in HF (sacubitril/valsartan [SV] and aspirin [acetylsalicylic acid]) or with a narrow therapeutic index (warfarin) were evaluated in three phase I studies. ## Results Vericiguat 15 mg (single dose [SD]) had no effect on bleeding time or platelet aggregation when coadministered with aspirin 1000 mg versus aspirin alone: estimated differences in least squares means 2.7% (95% confidence interval [CI] − 90.4 to 95.8) and 2.4% (95% CI − 7.0 to 11.8) turbidimetry, respectively. Vericiguat 10 mg (once daily) had no effect on coagulation inhibition elicited by warfarin 25 mg (SD; mean ratios of area under the concentration–time curve from time zero to 96 h for clotting parameter treatment comparisons approximated 100.0%). There were no clinically relevant PD changes whether SV 97/103 mg was administered with single or multiple doses of vericiguat 2.5 mg or placebo (differences in systoli

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Author

Michael Boettcher; Stephanie Loewen; Mireille Gerrits; Corina Becker

Publisher

Springer Science and Business Media LLC

Published

2020

Language

EN

Field

Medicine (Health Sciences)