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Evaluation of high‐sensitivity C‐reactive protein and uric acid in vericiguat‐treated patients with heart failure with reduced ejection fraction
Author(s) -
Kramer Frank,
Voss Sebastian,
Roessig Lothar,
Igl BerndWolfgang,
Butler Javed,
Lam Carolyn S.P.,
Maggioni Aldo P.,
Shah Sanjiv J.,
Pieske Burkert
Publication year - 2020
Publication title -
european journal of heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.149
H-Index - 133
eISSN - 1879-0844
pISSN - 1388-9842
DOI - 10.1002/ejhf.1787
Subject(s) - placebo , medicine , interquartile range , ejection fraction , heart failure , c reactive protein , uric acid , gastroenterology , inflammation , pathology , alternative medicine
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.