乌鸦传媒

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LISBON -- Presence of diabetes had no bearing on cardiovascular risk reduction with the PCSK9 inhibitor evolocumab (Repatha) in the FOURIER trial, researchers said here.

The 40% of patients in the trial who had diabetes saw at least as good a reduction in the primary composite endpoint of cardiovascular death, myocardial infarction, stroke, hospital admission for unstable angina, or coronary revascularization, with a hazard ratio of 0.83 (95% CI 0.75-0.93) compared with 0.87 (95% CI 0.79-0.96) among participants without diabetes (P for interaction=0.60).

New-onset diabetes and glycemia weren't worsened by the drug, including in patients with prediabetes at baseline, Marc Sabatine, MD, of Brigham and Women's Hospital and Harvard in Boston, and colleagues reported here at the European Association for the Study of Diabetes meeting and simultaneously online in the Lancet Diabetes and Endocrinology.

"Recent guidelines have recommended identifying patients with diabetes and established atherosclerotic cardiovascular disease as having an extreme risk and requiring more intensive treatment to achieve lower LDL cholesterol goals. With similar relative and greater absolute risk reduction in patients with diabetes, and no discernible effect on glycemia, PCSK9 inhibition might be a particularly attractive therapy in this population," the group wrote.

But there's one catch, cautioned Luca Lotta, MD, PhD, and Simon Griffin, DM, both of the University of Cambridge School of Clinical Medicine in England, in an accompanying editorial.

They wrote that "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."

Increased risk of type 2 diabetes has been a concern with statins, albeit the net effect on risk of cardiovascular disease still "strongly justifies their use irrespective of this concern." The FOURIER findings in that regard were reassuring on face, but they weren't sufficient to exclude a small to moderate effect of evolocumab on diabetes risk. That would require pooling of data from several trials, Lotta and Griffin wrote.

The prespecified secondary analysis of FOURIER included the 27,564 statin-treated patients with atherosclerotic disease in the trial, who were randomized to evolocumab (140 mg every 2 weeks or 420 mg once a month) versus placebo for a median of 2.2 years. Diabetes status at baseline was defined by patient history, clinical events committee review of medical records, or baseline HbA1c of 6.5% or greater or fasting plasma glucose of 7.0 mmol/L or greater.