Physicians' Academy for Cardiovascular Education

PCSK9 antibody does not increase HbA1c, fasting glucose or diabetes risk

Effect of the Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Evolocumab on Glycemia, Body Weight, and New-Onset Diabetes Mellitus

Sattar N, Toth PP, Blom DJ, et al. - American Journal of Cardiology 2017; published online ahead of print

Background

Although statin therapy is safe and effective lowering LDL-c and cardiovascular risk, it can lead to a modest increase in HbA1c levels and risk of developing diabetes [1,2]. Evolocumab, a PCSK9 antibody, leads to significant reductions of LDL-c and cardiovascular events, and first data showed that it has no notable effect on measures of glycemia and new-onset diabetes mellitus compared with placebo [3,4].

In this study, the effect of evolocumab on measures of glycemic control, weight or new-onset diabetes mellitus was evaluated for the duration of 1 year, in two open-label extension studies: OSLER-1 and OSLER-2 [5]. In these studies, which included 4,802 participants from 13 parent trials, patients were randomized in a 2:1 ratio to evolocumab plus standard of care (SOC) or to SOC alone for the first year, regardless of treatment allocation in the parent trial. Evolocumab was administered at a dose of 420 mg once a month in OSLER-1 and, based on participant choice, at a dose of either 140 mg every 2 weeks or 420 mg once a month in OSLER-2. In OSLER-1, randomization was stratified by treatment arm in the parent study, while in OSLER 2 it was stratified by parent study and frequency of subcutaneous dosing.

Main results

Conclusion

In two open-label extension studies, treatment with evolocumab plus SOC for the duration of 1 year did not increase HbA1c, fasting glucose or diabetes risk in comparison to SOC alone. Participants in the evolocumab plus SOC group had a slight increase in weight, which was mainly driven by participants without diabetes or with a low risk for diabetes.

References

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Find this article online at Am J Cardiol