Amgen announced new data from the FOURIER trial which showed that Repatha (evolocumab) significantly and consistently lowered cardiovascular events in patients with and without diabetes. The full findings were presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Lisbon, Portugal.

At study baseline, 40% (n=11,031) of patients had diabetes and 60% (n=16,533) did not; of these patients, 10,344 had prediabetes and 6,189 had normoglycemia. At 48 weeks, the diabetes subgroup had a 57% mean reduction in LDL-C levels with Repatha (95% CI: 56–58; P<0.0001) and the non-diabetes subgroup had a 60% mean reduction in LDL-C levels with Repatha (95% CI: 60–61; P<0.0001) at 48 weeks. 

The hazard ratio (HR) of Repatha treatment for the composite primary endpoint (hospitalization for unstable angina, coronary revascularization, heart attack, stroke, cardiovascular death) was 0.83 (95% CI: 0.75–0.93; P=0.0008) for those with diabetes and 0.87 (95% CI: 0.79–0.96; P=0.0052) for those without diabetes. Treatment with Repatha tended to result in greater absolute risk reduction of cardiovascular events among patients with diabetes vs. no diabetes due to their increased baseline risk (2.7% vs. 1.6%). 

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Consistent with overall trial outcomes, the extent of risk reduction in both primary and secondary endpoints increased over time beyond the first year in patients with and without diabetes. 

Compared to placebo, Repatha was not associated with an increased risk of developing new-onset diabetes or worsening glycemia over a median follow-up period of 2.2 years in patients without diabetes at baseline (8.0% vs. 7.6%, HR 1.00, 95% CI: 0.89–1.13). 

Repatha, a proprotein convertase subtilisn/kexin type 9 (PCSK9) inhibitor, is indicated as adjunct to diet and maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C; and as adjunct to other LDL-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C.

Lead author Marc S. Sabatine, MD, from Brigham and Women’s Hospital, Boston, MA, added, “Importantly, this analysis also provides additional evidence that evolocumab is equally safe in patients with and without diabetes.”

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