Abstract
Background/Introduction
Cardiovascular (CV) disease represents the leading cause of death and disability in developed countries with elevated LDL-C among the main risk factors for CV events.
Purpose
We conducted a study to describe the clinical profile of patients initiating evolocumab in real-world clinical practice, specifically hospital cardiology units in Spain.
Methods
Retrospective, observational, serial chart review of consecutive hyperlipidemic patients (≥18 years) who initiated evolocumab in 31 Spanish hospital cardiology units from February-2016 to May-2017. Relevant patients characteristics and clinical data were collected from medical records at 12 weeks pre- and 12±4 weeks post-evolocumab initiation. Baseline values correspond to data collected up to 12 weeks prior to initiation of evolocumab.
Results
186 patients were enrolled: 72.0% men, mean (SD) age 60.3 (9.8) years, mean (SD) body mass index 28.5 (4.3) kg/m2. CV history and CV risk factors at evolocumab initiation are summarised below (Figure). Half of all patients were statin intolerant and almost all (94.1%) were secondary prevention. At baseline, half (51.1%) of all patients were receiving ezetimibe and 44.1% were receiving high-intensity statins. At baseline, mean (SD) LDL-C was 144.0 (49.0) mg/dL; 38.7% of patients had LDL-C 100-<130 mg/dL, 28.0% had LDL-C 130-<160 mg/dl, 12.4% had LDL-C ≥160 mg/dL, 12.9% had LDL-C ≥190 mg/dL. Mean (SD) baseline HDL-C was 47.7 (13.0) mg/dL. After 12 weeks of evolocumab treatment, mean (SD) LDL-C was reduced by 57.6% (21.6) to 62.2% (44.1) mg/dL (p<0.0001; LDL-C reductions of 57.5% [23.2]/57.6% [21.6] in patients with/without FH and 46.0% [21.5]/58.5% [22.1] in primary/secondary prevention patients, respectively). At week 12, 64.9% patients reached LDL-C levels <70 mg/dL, and 49.1% <50 mg/dL, while statin use remained stable (data not shown). Only 3.2% (n=6) patients discontinued evolocumab (voluntary withdrawal, mostly).
Baseline CV history and CV risk factors
Conclusions
In Spanish Cardiology Units, evolocumab was typically prescribed in patients with FH and/or atherosclerotic cardiovascular disease, aligned with 2016 ESC/EAS guidelines recommendation on PCSK9i usage. Patients tended to have LDL-C levels above the recommended thresholds with LDL- levels markedly reduced after 12 (± 4) weeks of evolocumab treatment.
Acknowledgement/Funding
This work was supported by Amgen.