Dr Robert P. Giugliano Discusses the Significance of the FOURIER and EBBINGHAUS Trials
Robert P. Giugliano, MD, MSc, associate professor of medicine at Harvard Medical School, discussed the findings of the EBBINGHAUS study on evolocumab’s effect on cognition, which he presented at the American College of Cardiology 66th Scientific Session. He also explained how that study was related to the highly-anticipated FOURIER trial.
Transcript (slightly modified) How is EBBINGHAUS related to the FOURIER trial?
The FOURIER trial was the large cardiovascular outcomes trial that enrolled over 27,000 patients. In order to get into this cognitive study called EBBINGHAUS, you had to be enrolled and participating in the FOURIER trial. So in a sense the EBBINGHAUS is a subset of patients who were enrolled in FOURIER; like I said, a little under 2000 of the 27,000-plus enrolled in FOURIER.
Are there further studies planned to investigate the use of evolocumab in general clinical practice?
Here, the trial was rather short, so FOURIER overall lasted 26 months, the average follow-up in EBBINGHAUS was about 20 months. We prescribe drugs to lower cholesterol for decades, if not a patient’s lifetime. Amgen, the sponsor of the trial, has committed to an open-label extension study, and a subgroup of patients are going to continue to do cognitive testing periodically over a period of several years.
Why are the EBBINGHAUS and FOURIER studies significant?
If you take a step back and say, what have we learned from these studies together, EBBINGHAUS and FOURIER, I mean these are really ground-breaking in that we are now driving LDL down to extremely low levels that are unprecedented, and we’re finding that it’s efficacious, it reduces the risk of heart attack and ischemic stroke, and safe. Specifically from EBBINGHAUS, the cognitive functions of the patients were unchanged.