According to Amgen, Repatha’s effect on the primary endpoint of executive function was non-inferior to placebo. The study showed that on other cognitive domain tests – working memory, memory function and psychomotor speed – Repatha was not statistically different than placebo.
"There has long been a debate that low LDL cholesterol levels could lead to negative effects on memory or other cognitive functions," Dr. Robert Giugliano, of Brigham and Women's Hospital in Boston and lead study investigator, said. "We did not find evidence for a decline in neurocognitive function after nearly two years of treatment with evolocumab using a dedicated series of neuropsychologic tests. We also asked patients and their physicians to provide their assessments and found no differences between evolocumab and placebo. These findings provide strong support for the safety of reducing LDL with evolocumab to levels well below current treatment targets."
The Cambridge Neuropsychological Test Automated Battery Spatial Working Memory strategy index of executive function assessed the primary endpoint of the study.
The study also included exploratory analysis that results were consistent regardless of achieved low-density lipoprotein cholesterol (LDL-C) levels. This included an examination of 661 patients with the lowest LDL-C level.
"These results, from one of the largest randomized controlled trials on cognitive function, clearly demonstrated that lowering LDL-C to unprecedented levels with Repatha did not negatively impact cognition," Dr. Sean Harper, Amgen's executive vice president of research and development, said.
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