Real-world data of PCSK9i use in FH patients

EAS 2021 An interim-analysis of the HEYMANS study showed that the majority of FH (both HeFH and HoFH) patients have a history of CV events and comorbidities. Initiation of evolocumab in these patients resulted in reduced LDL-c levels, maintained throughout the study.

Presented at the virtual EAS 2021 by Kausik Ray (London, UK)

Introduction and methods

The 2019 ESC/EAS guidelines recommend ≥50% lowering of LDL-c in patients with very-high CV risk when LDL-c target goals have not been achieved, despite maximally tolerated statins and ezetimibe. Use of PCSK9 inhibitors is recommended for these patients. Although the efficacy of PCSK9 inhibitors have been demonstrated in clinical trials, there is limited data on PCSK9i use in routine clinical practice.

In the HEYMANS study, real-world use of evolocumab is described in patients who initiated evolocumab in Europe. HEYMANS is an observational, multicenter cohort study in 12 European countries. Adults (≥18 years) who have initiated evolocumab as part of clinical management after August 1, 2015 are enrolled. Follow-up is up to 30 months after evolocumab initiation.

This interim analysis reported data from 801 patients with FH (HeFH [n=766) or HoFH [35) with follow-up until July 2020.

Main results

• Main diagnostic methods used were Dutch Lipid Clinical Network (40%), genetic testing (32%) and LDL-c (19%).
• Vast majority of HeFH patients had a history of CV events and additional CV comorbidities.
• 44.5% of HeFH patients were not on a statin, 43.5% were not on ezetimibe. 33.9% Of patients used high-intensity statin with ezetimibe.
• Median LDL-c at baseline was 4.30 mmol/L in patients. After initiation of evolocumab LDL-c was reduced by ~2/3, which was maintained throughout 24 months.
• In patients with HoFH, the majority had a past CV event and additional comorbidities. 37% Of patients were not on a statin, 51.4% were not on ezetimibe and 28.6% used high-intensity statin with ezetimibe. A few used lomitapide or underwent apheresis during the study.
• Starting level of LDL-c was 4.280 mmol/L in HoFH patients and LDL-c was reduced by ~1/3 after initiation of evolocumab, which was maintained throughout the study.

Conclusion

Large reductions in LDL-c were observed after initiation of evolocumab in patient with FH, either HeFH or HoFH. These findings are similar to those in clinical trials (which enroll more homogenous populations). Ray ended by saying that the real challenge lies in initiation of implementation of these treatments.

-Our reporting is based upon the information provided at the EAS 2021 congress-