Clinical Edge

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CV Safety of Evolocumab in Patients with Diabetes

Lancet Diabetes Endocrinol; ePub 2017 Sep 12; Sabatine, et al

In patients with and without diabetes, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition with evolocumab significantly reduced cardiovascular (CV) risk, a new study found, without risk of new-onset diabetes or worsening glycaemia. The prespecified analysis of the FOURIER randomized controlled trial examined the efficacy and safety by diabetes status and the effect of evolocumab on glycaemia and the risk of developing diabetes. The FOURIER trial evaluated evolocumab (140 mg every 2 weeks or 420 mg once per month) vs placebo and included 27,564 patients with atherosclerotic disease who were on statin therapy, followed up for a median of 2.2 years. Researchers found:

  • At baseline, 11,031 patients (40%) had diabetes and 16,533 did not have diabetes.
  • Evolocumab significantly reduced CV outcomes consistently in patients with and without diabetes at baseline.
  • Evolocumab did not increase the risk of new-onset diabetes in patients without diabetes at baseline, including in those with prediabetes (HR, 1.00).
  • Levels of HbA1c and fasting plasma glucose were similar between the groups over time in patients with diabetes, prediabetes, or normoglycaemia.

Citation:

Sabatine MS, Leiter LA, Wiviott SD, et al. Cardiovascular safety and efficacy of the PCSK9 inhibitor evolocumab in patients with and without diabetes and the effect of evolocumab on glycaemia and risk of new-onset diabetes: A prespecified analysis of the FOURIER randomised controlled trial. [Published online ahead of print September 12, 2017]. Lancet Diabetes Endocrinol. doi:10.1016/S2213-8587(17)30313-3.

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