Termination of the FOURIER Legacy Programme
FOURIER LEGACY was an investigator led observational study with two
objectives:
First- to establish whether, by analogy with long term follow up observations
on patients formerly participating in statin trials, there were continuing
benefits of the PCSK9 monoclonal antibody, evolocumab, beyond the period of
observation during the FOURIER Trial, and
Second- to determine whether during longer term follow up the non-fatal
cardiovascular outcome benefits of evolocumab reported during the trial could
be extended to include outcome reductions in cardiovascular deaths.
The investigators designed the follow up, legacy, programme and after lengthy
discussions with the funders of the original trial, Amgen, agreed a protocol and
funding for a study of 10,000 former FOURIER patients to be recruited from
more than 25 countries and followed up for 5 years post trial. The study was
sponsored and coordinated by the University of Sydney with 3 regional
partners- Imperial College London, the TIMI Group Boston and the University
of Oslo.
However, four years into the follow up study and 2 years after signing the
definitive agreement, during which the teams of 25 national investigators, over
500 sites and more than 1000 research staff were involved in setting up the
programme, obtaining ethical review, identifying possible patients, contacting
patients and collecting follow up data, in December 2020, Amgen took the
decision to halt the programme and cease funding. We understand that the
company wished to reallocate funds from the FOURIER Legacy study to support
alternative studies.
At the time of termination of the study approximately 1300 patients had been
recruited into the follow up programme. Analyses of the available data are
currently in progress and the outcome will be presented in a future report.