Physicians' Academy for Cardiovascular Education

Long-term PCSK9 inhibition consistently lowers LDL-C in open-label extension study

Long-term Low-Density Lipoprotein Cholesterol–Lowering Efficacy, Persistence, and Safety of Evolocumab in Treatment of Hypercholesterolemia

Results Up to 4 Years From the Open-Label OSLER-1 Extension Study

Literature - Koren MJ, Sabatine MS, Giugliano RP, et al. - JAMA Cardiol 2017; published online ahead of print

Main results

Conclusion

In OSLER-1, an open-label extension study of 5 double-blind phase 2 parent studies, evolocumab consistently lowered LDL-C levels for an average of 44 months, in a diverse patient population with hypercholesterolemia. There were no concerning safety signals and no neutralising antibodies. These data suggest that long-term evolocumab therapy is beneficial and well tolerated.

Editorial comment

In this editorial article, Stone points out the limitations of the study of Koren et al, which include the lack of a placebo group, the restricted sample size, and the open-label design, in which responders dominate the results. The author concludes: ‘What is new is not the substantial initial LDL-C level lowering seen with PCSK9 inhibitors, but the maintenance of that lowering for up to 4 years with evolocumab. It is reassuring to find no significant levels of measured neutralizing antibodies with this fully human PCSK9 inhibitor. The adherence achieved in this open-label extension study is adequate, but it should be noted that participants were shielded from the current high cost of these drugs. It is hoped that if outcome trial data are shown to be beneficial, cost will not be a limiting factor for those who would have the largest incremental benefit.’

References

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Find this article on line at JAMA cardiol

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