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WASHINGTON -- Reaching very low LDL levels with a PCSK9 inhibitor was not associated with any increase in neurocognitive adverse events, according to the largest and most rigorous study to assess the topic to date.
Small and preliminary studies have raised concerns over the possibility of the neurocognitive effects of statins. Though most clinicians and scientists have not shared these concerns, consumers and patients have expressed broad suspicions about statins.
"In my office every day my patients say that statins make them dumb. I can comfortably tell my patients that we actually studied whether this makes you dumb, and it didn't," said Sandra Lewis (Oregon Health and Science University).
The new study, called EBBINGHAUS, was a substudy of the enormous FOURIER trial, , which compared the cardiovascular event impact of PCSK9 inhibition with evolocumab (Repatha) or placebo. EBBINGHAUS tested the hypothesis that "the addition of evolocumab to statin therapy in patients with clinically evident vascular disease does not adversely affect cognitive function."
The results were presented at the American College of Cardiology meeting here by Robert Giugliano (Brigham & Women's Hospital). "We all need your help to combat Dr. Google," he told the media at a press conference.
EBBINGHAUS enrolled 1,974 patients from the FOURIER trial. The primary analysis was based on the cohort of 1,204 patients who had baseline and follow-up cognitive testing, consisting of a battery of tests, patient surveys, and investigator-reported adverse events. There were no significant differences between the groups in the primary endpoint, the spatial working memory strategy index, or any of the other measures in the study.
"It's out there on the Internet that statins make people stupid," said Roger Blumenthal (Johns Hopkins), a trial discussant. EBBINGHAUS "advanced the field by showing that pharmacologically achieved low levels of LDL are safe," he said. But Giugliano and others acknowledged that the trial tested the effect of a PCSK9 inhibitor and did not assess the effects of statins, which are much more widely used. But the lack of adverse effects in patients reaching extremely low LDL levels (30 mg/dL) in the FOURIER trial will likely add much reassurance.
Giugliano reported that there were no differences between older and younger patients in EBBINGHAUS. But the trial did not address the concerns that have been raised about the effects of very long-term lipid-lowering therapy for primary prevention.