This study is a follow up from the FOURIER Outcomes trial, to take part you must have already been a participant in this previous trial. There are full details of FOURIER Outcomes below, or if you want to find out more about our current FOURIER Legacy study read our 'Why this study' page.

The FOURIER Outcomes trial

FOURIER Outcomes was an international double blind clinical trial with over 25,000 participants who randomly received either evolocumab or a placebo via an injection every 2 or 4 weeks.

Evolocumab is a new drug which lowers LDL-cholesterol (so-called ‘bad’ cholesterol) by increasing the number of LDL receptors on the liver surface, thereby helping the liver to clear LDL cholesterol from the blood stream.

The objective of the study was to see whether evolocumab was more effective than a placebo in preventing a combination of cardiovascular ‘events’- such as a non-fatal heart attack, non-fatal stroke hospitalisation for unstable angina, and death from cardiovascular disease.

The trial was initially planned to continue for 5 years, but, because of the high rate of cardiovascular ‘events’, the trial closed after just over 2 years, in December 2016.

The results of the study were reported by the American College of Cardiology and were published in the New England Journal of Medicine.

In summary, the results showed that evolocumab reduced the risk of the one set of combined cardiovacular events by 15% and reduced the second set of ombined cardiovacular events (heart attack, stroke and cardiovascular death) by 20%. Evolocumab significantly reduced the incidence of heart attacks (27%), stroke (21%), coronary revascularisation (22%). Because the study was closed earlier than anticipated, no significant effects on death from cardiovascular or other causes were seen. This is one of the reasons for proceeding with the FOURIER LEGACY study.

Safety

There were slightly more injection site reactions (redness and swelling) amongst patients who took evolocumab, compared with placebo. There were no other adverse events that could be attributed to evolocumab treatment- adverse events were generally mild, and they occurred just as often in patients on placebo as in those taking evolocumab.

Interestingly, unlike the findings with statins, evolocumab did not appear to increase the risk of developing diabetes.

Professor Marc Sabatine discussing the FOURIER results.

Discussion on the FOURIER results

Professor Marc Sabatine discussing the FOURIER Outcomes trial results.

Prof Robert Giugliani discussing the effects of evolocumab

The effects of evolocumab on cognitive function

Professor Robert Giugliani discussing the effects of evolocumab on cognitive function in the Ebbinghaus sub-study of FOURIER Outcomes.

Antibody Therapeutics

Antibody Therapeutics

Learn about the different forms of monoclonal antibody therapeutics available to date and their mode of action.

Videos kindly supplied thanks to AMGEN

New issues in cardiovascular disease prevention and awareness of familial hypercholesterolaemia

New issues in cardiovascular disease prevention

New issues in cardiovascular disease prevention (CVD) and awareness of familial hypercholesterolaemia (FH).

In this short video, Dr Susan Connolly from Imperial College London discusses the new issues in CVD prevention and also touches on awareness of familial hypercholesterolaemia.

Videos kindly supplied thanks to AMGEN

Familial hypercholesterolaemia

Familial hypercholesterolaemia

Professor John Betteridge from University College Hospitals London describes the causes and prevalence of familial hypercholesterolaemia, simple ways to assess patients and make the diagnosis, and the fundamentals of managing FH patients.

Videos kindly supplied thanks to AMGEN