SOCRATES-REDUCED Finds No Benefit to Vericiguat in Chronic HF Patients
In chronic heart failure (HF) patients with reduced left ventricular ejection fraction (LVEF), vericiguat "did not have a statistically significant effect" on change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, according to results from the SOCRATES-REDUCED study presented Nov. 8 during AHA 2015 in Orlando and simultaneously published in the Journal of the American Medical Association.
The phase 2 study looked at 456 patients from across Europe, North America, and Asia with worsening chronic HF and reduced LVEF, who were randomly assigned to receive placebo or one of four daily doses (1.25 mg, 2.5 mg, 5 mg or 10 mg) of the drug vericiguat for 12 weeks.
Results showed that overall, 351 patients (77 percent) completed treatment with the study drug with valid 12-week NT-proBNP levels. In the primary analysis, change in NT-proBNP levels from baseline to week 12 "was not significantly different" between the pooled vericiguat group as compared to the placebo group. However, the authors’ secondary analysis suggested a dose-response relationship, such that higher vericiguat doses were associated with greater reductions in NT-proBNP level.
The authors conclude that moving forward, "further clinical trials of vericiguat based on the dose-response relationship in this study are needed to determine the potential role of this drug for patients with worsening chronic HF."
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