EBBINGHAUS trial evaluating Repatha (evolocumab) shows no adverse affect on cognitive function in treating dyslipidaemia- Amgen

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). The study demonstrated that the effect of Repatha on the primary endpoint of executive function was non-inferior to placebo. In addition, there was no statistical difference between Repatha and placebo on the other cognitive domains tested: working memory, memory function and psychomotor speed (secondary endpoints).

In the primary cohort of 1,204 patients, followed for a median of 19 months, the change from baseline raw score of spatial working memory strategy index of executive function was similar in the Repatha and placebo groups (mean baseline score 17.8; mean change from baseline -0.2 versus -0.3, respectively). The primary endpoint was below the pre-specified margin, demonstrating non-inferiority.

Secondary endpoint results in the three cognitive domains of working memory, memory function and psychomotor speed were consistent with the primary endpoint result. Patients treated with Repatha experienced change from baseline similar to placebo in all three cognitive domains tested: spatial working memory between-errors score (baseline 21.0, Repatha -0.5 versus placebo -0.9), paired associates learning total errors adjusted (baseline 25.8, change with Repatha -1.5 versus -1.5 with placebo), RTI median five-choice reaction time (baseline 355.9, 5.2 milliseconds change with Repatha versus 0.9 milliseconds with placebo). Changes from baseline in the global composite score were similar between treatment arms (baseline -0.008, changes with Repatha 0.03 versus 0.06 with placebo). The detailed results from EBBINGHAUS were presented at a Late-Breaking Clinical Trials Session at the American College of Cardiology 66th Annual Scientific Session.