@article{c0451884bf3047438d06c37106666323,
title = "Evaluation of high-sensitivity C-reactive protein and uric acid in vericiguat-treated patients with heart failure with reduced ejection fraction",
abstract = "Aims: The effects of vericiguat vs. placebo on high-sensitivity C-reactive protein (hsCRP) and serum uric acid (SUA) were assessed in patients with heart failure with reduced ejection fraction (HFrEF) in the Phase 2 SOCRATES-REDUCED study (NCT01951625). Methods and results: Changes from baseline hsCRP and SUA values at 12 weeks with placebo and vericiguat (1.25 mg, 2.5 mg, 5.0 mg and 10.0 mg, respectively) were assessed. The probability of achieving an hsCRP value of ≤3.0 mg/L or SUA value of <7.0 mg/dL at week 12 was tested. Median baseline hsCRP and SUA levels were 3.68 mg/L [interquartile range (IQR) 1.41–8.41; n = 335] and 7.80 mg/dL (IQR 6.40–9.33; n = 348), respectively. Baseline-adjusted mean percentage changes in hsCRP were 0.2%, −19.5%, −24.3%, −25.7% and −31.9% in the placebo and vericiguat 1.25 mg, 2.5 mg, 5.0 mg and 10.0 mg groups, respectively; significance vs. placebo was observed in the vericiguat 10.0 mg group (P = 0.035). Baseline-adjusted mean percentage changes in SUA were 5.0%, −1.3%, −1.1%, −3.5% and −5.3% in the placebo, and vericiguat 1.25 mg, 2.5 mg, 5.0 mg and 10.0 mg groups, respectively; significance vs. placebo was observed in the 5.0 mg and 10.0 mg groups (P = 0.0202 and P = 0.004, respectively). Estimated probability for an end-of-treatment hsCRP value of ≤3.0 mg/L and SUA value of <7.0 mg/dL was higher with vericiguat compared with placebo. The effect was dose-dependent, with the greatest effect observed in the 10.0 mg group. Conclusions: Vericiguat treatment for 12 weeks was associated with reductions in hsCRP and SUA, and a higher likelihood of achieving an hsCRP value of ≤3.0 mg/L and SUA value of <7.0 mg/dL.",
keywords = "Biomarker, C-reactive protein, Heart failure, Uric acid, Ventricular ejection fraction, Vericiguat",
author = "Frank Kramer and Sebastian Voss and Lothar Roessig and Igl, {Bernd Wolfgang} and Javed Butler and Lam, {Carolyn S.P.} and Maggioni, {Aldo P.} and Shah, {Sanjiv J.} and Burkert Pieske",
note = "Funding Information: Part of this analysis was presented at the 2018 European Society of Cardiology Heart Failure Congress. Medical writing and editorial assistance were provided by Laila Guzadhur, PhD, Moamen Hammad, PhD and Annabel Ola, MSc, all of Scion (London, UK). This assistance was funded by Bayer AG (Berlin, Germany) and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Kenilworth, NJ, USA). Funding Information: Funding for this research was provided by Bayer AG (Berlin, Germany) and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Kenilworth, NJ, USA). Funding Information: Conflicts of interest: F.K. and L.R. are employees of Bayer AG. S.V. is an employee of Chrestos Concept, a contract partner of Bayer. B.‐W.I. was an employee of Bayer during the course of the SOCRATES‐REDUCED study and is currently employed by Boehringer Ingelheim. J.B. has received research support from the US National Institutes of Health, the European Union, and the Patient‐Centered Outcomes Research Institute, and consults for Abbott, Adrenomed, Amgen, Array, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cardiocell, Corvidia, CVRx, G3 Pharmaceutical, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck Sharp & Dohme, Novartis, NovoNordisk, Relypsa, Roche, Sanofi, V‐Wave and Vifor. C.S.P.L. has received research support from Boston Scientific, Bayer, Roche Diagnostics, AstraZeneca, Medtronic and Vifor Pharma, and has served as a consultant or on the advisory board/steering committee/executive committee for Boston Scientific, Bayer, Roche Diagnostics, AstraZeneca, Medtronic, Vifor Pharma, Novartis, Amgen, Merck Sharp & Dohme, Janssen Research & Development, Menarini, Boehringer Ingelheim, NovoNordisk, Abbott Diagnostics, Corvia, Stealth BioTherapeutics, JanaCare, Biofourmis, Darma, Applied Therapeutics, MyoKardia, WebMD Global, Radcliffe Group and Corpus. A.P.M. has served as a committee member on clinical studies sponsored by Bayer and Novartis. S.J.S. reports the receipt of research grants from the National Institutes of Health (R01 HL107577, R01 HL127028, R01 HL140731, R01 HL149423), Actelion, AstraZeneca, Corvia and Novartis, and has served as a consultant/advisory board member for Abbott, Actelion, AstraZeneca, Amgen, Bayer, Boehringer‐Ingelheim, Cardiora, Coridea, CVRx, Eisai, Ionis, Ironwood, Merck Sharp & Dohme, MyoKardia, Novartis, Pfizer, Sanofi, Tenax and United Therapeutics. B.P. is a steering committee member of the SOCRATES‐REDUCED study and a consultant/steering committee member for Bayer, Merck Sharp & Dohme, Novartis, Stealth Peptides, Daiichi‐Sankyo, AstraZeneca, BMS and Servier. ",
year = "2020",
month = sep,
day = "1",
doi = "10.1002/ejhf.1787",
language = "English (US)",
volume = "22",
pages = "1675--1683",
journal = "European Journal of Heart Failure",
issn = "1388-9842",
publisher = "Oxford University Press",
number = "9",
}