medwireNews: A prespecified analysis of the FOURIER trial shows that the PCSK9 inhibitor evolocumab is as beneficial in patients with diabetes as in those without.
The analysis, presented at the EASD annual meeting in Lisbon, Portugal, shows that the risk for the primary endpoint of cardiovascular death, myocardial infarction, stroke, hospital admission for unstable angina, or coronary revascularization was reduced by 17% in FOURIER participants with diabetes and by 13% in those without.
FOURIER involved 27,564 patients with atherosclerotic disease who had elevated cholesterol levels despite optimized statin therapy. At baseline, 40% of these patients had diabetes, and their 3-year rate of primary endpoint events was 17.1%, which was significantly higher than the 13.0% in patients without diabetes, said presenter Marc Sabatine (Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA).
Evolocumab treatment over a median of 2.2 years lowered low-density lipoprotein cholesterol by 57% among patients with diabetes and by 60% in those without, reducing it to an average of 0.8 mmol/L in both groups.
This resulted in similar relative risk reductions for the primary endpoint in both groups, which increased over time. However, the higher baseline risk among the diabetes patients resulted in a larger absolute risk reduction and a smaller number needed to treat, at 2.7% and 37, respectively, over 3 years, compared with 1.6% and 62 over 3 years among the patients without diabetes.
Adverse event rates were similar in the evolocumab and placebo groups, and did not vary according to whether patients had diabetes. Of note, rates of new-onset diabetes were similar in evolocumab- and placebo-treated patients without diabetes at baseline, at 8.0% and 7.6%, respectively.
The study is simultaneously published in The Lancet Diabetes & Endocrinology, in which commentators Luca Lotta and Simon Griffin (University of Cambridge, UK) note that, although FOURIER was sufficiently powered to detect the new-onset diabetes risk increase predicted for PCSK9 treatment by genetic studies, these predicted risk estimates were for lifetime exposure, rather than the 2.2 years of treatment in the trial.
“Hence, a small to moderate effect of evolocumab on diabetes risk will only be excluded by the pooling of data from several trials, as was undertaken for statins,” they say.
The commentators say: “If PCSK9 inhibitors, or other emerging therapies, have few adverse effects, including a minimal effect on diabetes risk, such findings might influence prescribing decisions.
“However, in view of their high costs, access to PCSK9 inhibitors is likely to remain limited for the vast majority of the half a billion people with type 2 diabetes worldwide for the foreseeable future.”
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