1. Renal function and the effects of vericiguat in patients with worsening heart failure with reduced ejection fraction
- Author
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Christopher M. O'Connor, Lothar Roessig, Justin A. Ezekowitz, Adrian F. Hernandez, Carolyn S.P. Lam, Eugene B. Reyes, Joerg Koglin, Hillary Mulder, Johan Lassus, Martin R. Cowie, Javed Butler, Piotr Ponikowski, Paul W. Armstrong, Kevin J. Anstrom, Adriaan A. Voors, Burkert Pieske, Cardiovascular Centre (CVC), and HUS Heart and Lung Center
- Subjects
Male ,Cardiac & Cardiovascular Systems ,VICTORIA Study Group ,030204 cardiovascular system & hematology ,Kidney ,chemistry.chemical_compound ,0302 clinical medicine ,Medicine ,Estimated glomerular filtration rate ,1102 Cardiorespiratory Medicine and Haematology ,Research Articles ,Victoria Trial ,Ejection fraction ,Hazard ratio ,Heart failure with reduced ejection fraction ,3. Good health ,Treatment Outcome ,ENALAPRIL ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,Life Sciences & Biomedicine ,Research Article ,Glomerular Filtration Rate ,medicine.drug ,medicine.medical_specialty ,Renal function ,Heart failure ,Heterocyclic Compounds, 2-Ring ,03 medical and health sciences ,Internal medicine ,Humans ,Enalapril ,Aged ,Creatinine ,Science & Technology ,business.industry ,Proportional hazards model ,Stroke Volume ,medicine.disease ,Confidence interval ,Pyrimidines ,Cardiovascular System & Hematology ,chemistry ,3121 General medicine, internal medicine and other clinical medicine ,Cardiovascular System & Cardiology ,INHIBITORS ,business - Abstract
Aims Vericiguat reduced the primary composite outcome of cardiovascular death or heart failure (HF) hospitalization in patients with worsening HF with reduced ejection fraction (HFrEF) and a lower limit of baseline estimated glomerular filtration rate (eGFR) of 15 mL/min/1.73 m2. We evaluated the relationship between the efficacy of vericiguat and baseline and subsequent changes in renal function. Methods and results In VICTORIA, core laboratory serum creatinine was measured at baseline (n = 4956) and weeks 16, 32, and 48. Worsening renal function (WRF), defined as an increase ≥0.3 mg/dL in creatinine from baseline to week 16, was assessed via a Cox model with respect to subsequent primary events. Mean age was 69 years, 24% were female, and mean baseline eGFR was 61 mL/min/1.73 m2. During 48 weeks of treatment, the trajectories in eGFR and creatinine with vericiguat were similar to placebo (P = 0.50 and 0.18). The beneficial effects of vericiguat on the primary outcome were not influenced by baseline eGFR (interaction P = 0.48). WRF occurred in 15% of patients and was associated with worse outcomes (adjusted hazard ratio 1.28, 95% confidence interval 1.11–1.47; P, The left panel shows no differences in the change in creatinine (P = 0.18) between the vericiguat and placebo groups, as evaluated by the interaction between treatment and study visit in the model. The right panel shows a natural cubic spline plot showing that the treatment effect of vericiguat on the primary outcome was similar across the full range of estimated glomerular filtration rate (eGFR) (P = 0.23).
- Published
- 2021