FOURIER LEGACY
Research type
Research Study
Full title
Long term study of LDL-c Lowering with Evolocumab: Observational Follow-up after the FOURIER OUTCOMES Study
IRAS ID
236333
Contact name
Peter Sever
Contact email
Sponsor organisation
University of Sydney
Duration of Study in the UK
2 years, 8 months, 30 days
Research summary
Research Summary
FOURIER LEGACY is a 5 year questionnaire follow up of patients who completed the FOURIER outcomes study which closed in December 2016. (FOURIER OUTCOMES was a clinical trial comparing a new cholesterol lowering drug, evolocumab, with placebo in patients with cardiovascular disease and high cholesterol levels despite being treated with statins)
In the current study, FOURIER LEGACY subjects will be asked to complete a simple questionnaire either online or by telephone at enrolment and then at 36, 48 and 60 months after the FOURIER OUTCOMES trial closed.
They will be asked whether they have suffered a heart attack, stroke, have been admitted to hospital for heart disease, have had any stents inserted to their blood vessels and whether they are taking cholesterol-lowering medication.
They will be asked for consent for the study team to have access to their NHS hospitalisation and death records. They will also be asked for consent to allow their general practitioners to provide any further information on hospital admissions and procedures which are relevant to the study.
No study drug will be administered in this study, which is purely observational.Summary of Results
Summary of study findings Why were we conducting this study?
The FOURIER OUTCOMES study demonstrated that evolocumab dramatically reduced cholesterol levels and just over 2 years of follow-up significantly reduced cardiovascular events. In this trial, participants were randomly allocated to receive evolocumab or placebo, with an equal chance of receiving either treatment.
The aim of the FOURIER LEGACY study was to evaluate the potential long-term effects on cardiovascular outcomes of evolocumab treatment in participants who completed the FOURIER OUTCOMES trial, the cardiovascular outcomes of interest were cardiovascular death, myocardial infarction (heart attack), stroke and coronary revascularisation (unblocking coronary arteries).
The FOURIER OUTCOMES trial ended in November 2016. Participants who completed the trial were eligible to join FOURIER LEGACY study if they had not joined two related studies, called “Open Label Extension”. FOURIER LEGACY planned to open in 29 countries, recruiting up to 10,000 participants for up to 5 years from end of FOURIER OUTCOMES. The study first opened in the United Kingdom in February 2020, followed by the Netherlands, Norway, USA, Denmark, Finland, South Africa, Iceland, Australia and New Zealand.
What were participants asked to do in FOURIER LEGACY?
Participants who consented to FOURIER LEGACY completed a survey about their cardiovascular health. The survey was completed 6 months after they consented and then annually. If a participant reported experiencing a cardiovascular event their local FOURIER doctor provided information for data analysis.
The study information was analysed against several factors. This included the treatment a participant received in FOURIER OUTCOMES (evolocumab or placebo), their age, their gender and what region they lived in. In the cardiovascular health survey, participants were also asked whether they had continued to take certain types of cardiovascular medication after the FOURIER OUTCOMES trial ended and this information was also analysed.
What were the results of FOURIER LEGACY?
In December 2020, the funding body terminated the study, which halted progress to open the study in other countries. Data collection was finalised in April 2021.
In total, 1,137 participants completed the FOURIER LEGACY study with basic information collected for an additional 579 participants (whether they were alive or deceased). This meant information about whether a person was alive was known for 1716 participants who were followed-up for an average of 4 years after finishing the FOURIER OUTCOMES trial.
In the UK, 500 participants were recruited by Imperial College London.
Due to the study being terminated, there were far fewer participants recruited than planned, and therefore we were unable to collect sufficient information to draw meaningful conclusions and conduct all of the planned analyses. In the FOURIER LEGACY study, participants were fairly evenly distributed between those who received evolocumab or placebo in FOURIER OUTCOMES. Baseline characteristics were similar and there were no important differences between those who had received evolocumab and placebo in FOURIER OUTCOMES. There were no long-term safety concerns identified.
Treatment with evolocumab had already been shown in FOURIER OUTCOMES to demonstrate convincing benefits to reduce cardiovascular events.
Who organised and funded this study?
This is an international investigator-initiated study being sponsored by the University of Sydney, Australia. In [region] the study is being managed by [RCC] This study was fully funded by Amgen Inc. who may benefit financially from this study if, for example, the study assists the company to obtain additional approvals for Repatha (the brand name for evolocumab.REC name
Wales REC 6
REC reference
19/WA/0241
Date of REC Opinion
27 Sep 2019
REC opinion
Further Information Favourable Opinion