PCSK9 Drug Did Not Impact Cognition, Study Found

Loss of cognitive abilities is a concern among patients who take cholesterol-lowering drugs, with some patients complaining of “statin brain” or foggy thinking and some memory loss.

With the dawn of new effective cholesterol lowering drugs called PCSK9 inhibitors, there have been concerns that adding them to statin treatment could have a negative effect on cognition by depriving the brain of the cholesterol it needs to function properly.

Reporting today at ACC Scientific Sessions, Robert Giugliano, MD, said that in the EBBINGHAUS study, a project related to the FOURIER trial, there was no evidence of such problems.

Discussing the findings at a news conference this morning, Giugliano opened his remarks by welcoming reporters and adding "I'm glad you're all here because we need your help to combat 'Dr. Google,'" a constant source of misinformation for patients who go online to get medical advice, he said.

Giugliano, a senior investigator in the TIMI Study Group and a staff physican at Brigham and Women’s Hospital in Boston was lead author of the study.

His group looked into suggestions that surfaced in two 2015 studies that appeared to show cognition issues arose with PCSK9 drugs more frequently than with statins.

Those drugs were evolocumab and alirocumab.

In the EBBINGHAUS study 1,974 patients from the FOURIER study reported yesterday at ACC Scientific Sessions were enrolled. The average age was 63 and 75% had had a heart attack, 20% had had an ischemic stroke, and 19% had peripheral artery disease.

Patients with mental health conditions and neurological disorders were excluded.

The patients were given a battery of standard neurocognitive tests at the beginning of the study then again at 24, 48, and 96 weeks and at the end of the study.

The tests involved using a tablet computer, assessments of executive mental function, working memory, memory function and reaction time. They were also questioned about their everyday cognition before, during, and after the study.

“We found no important differences between patients taking evolocumab and those on placebo on any of the four measures of cognitive functioning, in the patient questionnaires or in the physician report of adverse cognitive events, Giugliano said.

Answering questions at the news conference he conceded that the patients studied were already taking statins so there was no attempt to see if the statins had already had an effect on their cognition. Another issue was that patients loss of cognitive skills normally declines with age.

The importance of the EBBINGHAUS study, he said, was that there was no relative difference in cognitive test score trends in the group whose members got PCSK9 inhibitors.

The patients were also assessed as to how low their LDL cholesterol had dropped. Again there were no differences in cognition, he said.

Commenting on the study at the news conference, panelist Sandy Lewis, MD, an Oregon cardiologist, said "I'm glad you mentioned Dr. Google; every day I have patients saying statins make them dumb and I say 'statins save your life'," she said.

One study limitation was that the study period was less than two years, but long-term follow-up is ongoing, he said.

The study was funded by Amgen.