Investigators simulated baseline CV risk and predicted potential risk reduction among a cohort of evolocumab users across Europe.
A 10-year prediction model of evolocumab (Repatha) use in clinical practice demonstrated it to be beneficial in reducing cardiovascular risk among patients with high LDL-C, according to findings presented at the European Society of Cardiology (ESC) 2020 Congress.
A team led by Kausik Ray, MD, MPhil, Professor of Public Health, Imperial College London, sought to further understand the potential benefits of evolocumab—which was demonstrated in the FOURIER trial—in the real-world using predictions and simulation models.
Their goal was to simulate baseline CV risk and assess potential risk reduction among a large cohort of evolocumab users in Europe.
The team used interim data from an observational study of patients being treated with evolocumab in clinical practice, including follow-up data, as well as routine medical records, which included demographic and clinical characteristics, lipid-lowering therapy, and lipid values.
The study consisted of 10 European countries and began August 2-15; the follow-up period ran for 18 months through October 2019.
A total of 779 patients initiating treatment were included in the analysis. The mean age was 62.7 years, and the mean baseline LDL-C was 3.85 mmol/L—which the investigators noted was much higher compared with the FOURIER trial mean LDL-C of 2.5 mmol/L.
For each patient, the team predicted/simulated 10-year CV risk using Reduction of Atherothrombosis for Continued Health (REACH) score, a simulation based on FOURIER trial patients, and a simulation based on real-world FOURIER-like patients from a published observational study.
They then calculated their absolute LDL-C reduction with evolocumab and simulated their relative risk reduction.
Their findings showed that the patients’ mean absolute LCL-C with evolocumab use was 2.1 mmol/L.
According to their prediction model using REACH score, the 10-year CV risk without evolocumab treatment was 35.7%. Risk with evolocumab treatment was 25.3%
Their simulation based on FOURIER trial patients showed that 10-year risk was 35.9% without treatment and 24.9% with treatment.
And finally, the simulation based on real-world FOURIER-like patients indicated that 10-year CV risk preceding treatment was 41.4% versus 29.3% risk after treatment.
The simulated relative risk reduction—which was done by using key secondary endpoint data in the FOURIER trial landmark analysis—was 33.3%.
“This cohort of evolocumab users in clinical practice had an almost 2-fold higher baseline LDL-C than patients enrolled in FOURIER trial, which translated to higher baseline CV risk,” they wrote. “For that reason, the estimated 10-year absolute benefit in this cohort was larger than expected based on FOURIER trial results.”
Other recent studies assessing FOURIER data and evolocumab efficacy have demonstrated that patients with metabolic syndrome may receive the most benefit—in terms of risk reduction—from evolocumab treatment. Yet, Ray and team’s study underscores the need to further assess CV treatment results and benefits in real-world clinical practice.
The study, “What potential risk reduction could be achieved with evolocumab treatment? a simulation based on observational data from a cohort of users in 10 European countries,” was presented at ESC 2020.