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

ABSTRACT:

Background and objectives

Vericiguat is a soluble guanylate cyclase stimulator indicated to reduce the risk of cardiovascular death and hospitalization due to heart failure. A dedicated QTc study in patients with chronic coronary syndromes demonstrated no clinically relevant QTc effect of vericiguat for exposures across the therapeutic dose range (2.5-10 mg). Interval prolongation concentration-QTc (C-QTc) modeling was performed to complement the statistical evaluations of QTc in the dedicated QTc study.

Methods

Individual time-matched, baseline- and placebo-corrected Fridericia-corrected QT interval values (ΔΔQTcF) were derived. Two approaches for ΔΔQTcF calculation were investigated: (1) ΔΔQTcF correction with data from a single baseline (as in the primary statistical anal

SUBMITTER: Ruehs H 

PROVIDER: S-EPMC10581916 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature