Physicians' Academy for Cardiovascular Education

Comprehensive safety analysis of PCSK9 antibody confirms positive benefit-risk profile

Pooled Safety Analysis of Evolocumab in Over 6000 Patients from Double-Blind and Open-label Extension Studies

Literature - Toth PP, Descamps O, Genest J, et al. - Circulation 2017; published online ahead of print

Background

Evolocumab, a PCSK9 inhibitor, significantly reduces LDL-C levels compared with placebo or ezetimibe, in patients with hypercholesterolemia, including those with familial hypercholesterolemia or other high-risk profiles, as well as in statin-intolerant patients, with a favourable safety and tolerability profile [1-5].

In this pooled analysis of the PROFICIO development program, the safety and tolerability of evolocumab was evaluated in more than 6000 patients enrolled in the randomised placebo- or ezetimibe-controlled phase 2 and 3 trials and during the Year 1 standard-of-care (SoC)-controlled portion of the open-label-extension (OLE) trials. The median evolocumab exposures were 2.8 months (phase 2 and 3 trials) and 11.1 months (extension studies).

Main results

Conclusion

A pooled analysis of data of more than 6000 patients confirmed the safety and tolerability of evolocumab, which was not associated with a significant risk for hepatotoxicity, muscle-related AEs, or neurocognitive events. These findings support the positive benefit-risk profile of evolocumab.

References

Show references

Find this article online at Circulation