Does Lowering LDL with Evolocumab Impact Cognitive Function?Por Fresco Pimienta Mar 20, 2017
Amgen has announced detailed results from the Repatha (evolocumab) cognitive function trial (EBBINGHAUS) evaluating the impact on cognitive function in 1,974 patients enrolled in the Repatha cardiovascular outcomes study (FOURIER).
"There has always been a debate that low LDL cholesterol levels could lead to negative effects on memory or other cognitive functions", said Robert P. Giugliano, M.D., S.M., Brigham and Women's Hospital, Boston and lead study investigator. The detailed results from EBBINGHAUS were presented at a Late-Breaking Clinical Trials Session at the American College of Cardiology 66th Annual Scientific Session (ACC.17) in Washington, D.C.
"After an average of 19 months of treatment, our data show that changes in memory and cognitive function were very small and similar between patients treated with evolocumab and those treated with placebo", said Robert Giugliano, MD, SM, a senior investigator in the TIMI Study Group and physician in the Cardiovascular Division at BWH. "We did not find evidence for a decline in neurocognitive function after almost two years of treatment with evolocumab using a dedicated series of neuropsychologic tests". The randomized, double-blind, placebo-controlled study included more than 27,000 patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter or higher who were receiving statin therapy. "We found no significant differences during the course of the study between the active and placebo treatment groups for any of these cognitive domains". However, previous research had raised the possibility that a low level of LDL cholesterol and/or use of statins may negatively impact memory and overall cognition.
Results showed a similar change in baseline raw score of spatial working memory strategy index of executive function in the evolocumab and placebo groups (mean change from baseline -0.2 vs. -0.3, respectively), assessed by the Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory strategy index of executive function. Results in the full cohort were consistent with those in the primary cohort. In the primary analysis, researchers compared changes in the baseline measurement in 1,204 patients who had a cognitive assessment on or prior to the first day they received evolocumab or placebo; a secondary analysis compared results in all 1,974 patients, including 770 patients who had baseline testing after the first dose but no later than the week 12 visit. Over a median of 2.2 years of followup, injection site reactions were the only adverse events that were nominally significantly more common with evolocumab; however, those were rare, at a rate of 2.1% compared with 1.6% in the placebo group. "These findings provide strong support for the safety of reducing LDL with evolocumab to levels well below current treatment targets". FOURIER was created to evaluate the impact of evolocumab on cardiovascular outcomes in patients on statin therapy, and found that evolocumab significantly reduced cardiovascular events, with a larger effect the longer patients were treated.
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