EBBINGHAUS: No Effect on Neurocognition With Evolucumab
In the largest study to address the question to date, researchers found no evidence that adding the PCSK9 inhibitor evolocumab on top of statin treatment causes memory loss or other cognitive issues, according to research presented by Robert P. Giugliano, MD, SM, FACC, on March 18 at ACC.17 in Washington, DC.
"Ours is the first prospectively designed study to evaluate the relationship between a PCSK9 inhibitor and changes in cognition, including memory, attention, and reaction time" said Giugliano of the EBBINGHAUS study, which enrolled 1,974 patients who were participating in the prospective outcomes study of evolocumab called FOURIER.
The patients in EBBINGHAUS were 63 years old on average and 28 percent were women; 75 percent had suffered a myocardial infarction, 20 percent an ischemic stroke, and 19 percent had peripheral arterial disease. All were receiving moderate- or high-intensity statin therapy and subcutaneous evolocumab 140 mg every two weeks or 420 mg every month. Exclusions from the EBBINGHAUS study were a diagnosis of dementia, cognitive impairment or another significant mental or neurological disorder.
The Cambridge Neuropsychological Test Automated Battery was completed by patients at study entry and at 24, 48, and 96 weeks, and at the end of the study to assess executive function, working memory, memory function and reaction time. They also completed a questionnaire assessing their everyday cognition before, during and at the end of the study.
The mean change in the primary endpoint of executive function as measured by the Spatial Working Memory strategy index was minus 0.29 with placebo and minus 0.21 with evolocumab (p for non-inferiority < 0.0001). The outcomes for all secondary endpoints were similar for placebo and evolocumab. Also similar were the patient self-reports via the questionnaire and the investigator reported cognitive adverse events for both placebo and evolocumab.
"Patients who reached very low LDL values – less than 25 mg/dL – had cognitive function that was similar with those with higher LDL values," said Giugliano, adding that these findings should "enable physicians to feel more secure about adding evolocumab to a statin to achieve very low levels of LDL cholesterol without worrying that patients' memory or cognitive functioning will be affected."
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