@article{Giugliano:2017:10.1016/S0140-6736(17)32290-0,
author = {Giugliano, RP and Pedersen, TR and Park, J-G and De, Ferrari GM and Gaciong, ZA and Ceska, R and Toth, K and Gouni-Berthold, I and Lopez-Miranda, J and Schiele, F and Mach, F and Ott, BR and Kanevsky, E and Pineda, AL and Somaratne, R and Wasserman, SM and Keech, AC and Sever, PS and Sabatine, MS and FOURIER, Investigators},
doi = {10.1016/S0140-6736(17)32290-0},
journal = {Lancet},
pages = {1962--1971},
title = {Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial},
url = {http://dx.doi.org/10.1016/S0140-6736(17)32290-0},
volume = {390},
year = {2017}
}

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TY  - JOUR
AB  - BACKGROUND: LDL cholesterol is a well established risk factor for atherosclerotic cardiovascular disease. How much one should or safely can lower this risk factor remains debated. We aimed to explore the relationship between progressively lower LDL-cholesterol concentrations achieved at 4 weeks and clinical efficacy and safety in the FOURIER trial of evolocumab, a monoclonal antibody to proprotein convertase subtilisin-kexin type 9 (PCSK9). METHODS: In this prespecified secondary analysis of 25982 patients from the randomised FOURIER trial, the relationship between achieved LDL-cholesterol concentration at 4 weeks and subsequent cardiovascular outcomes (primary endpoint was the composite of cardiovascular death, myocardial infarction, stroke, coronary revascularisation, or unstable angina; key secondary endpoint was the composite of cardiovascular death, myocardial infarction, or stroke) and ten prespecified safety events of interest was examined over a median of 2·2 years of follow-up. We used multivariable modelling to adjust for baseline factors associated with achieved LDL cholesterol. This trial is registered with ClinicalTrials.gov, number NCT01764633. FINDINGS: Between Feb 8, 2013, and June 5, 2015, 27564 patients were randomly assigned a treatment in the FOURIER study. 1025 (4%) patients did not have an LDL cholesterol measured at 4 weeks and 557 (2%) had already had a primary endpoint event or one of the ten prespecified safety events before the week-4 visit. From the remaining 25982 patients (94% of those randomly assigned) 13013 were assigned evolocumab and 12969 were assigned placebo. 2669 (10%) of 25982 patients achieved LDL-cholesterol concentrations of less than 0·5 mmol/L, 8003 (31%) patients achieved concentrations between 0·5 and less than 1·3 mmol/L, 3444 (13%) patients achieved concentrations between 1·3 and less than 1·8 mmol/L, 7471 (29%) patients achieved concentrations between 1·8 to less
AU  - Giugliano,RP
AU  - Pedersen,TR
AU  - Park,J-G
AU  - De,Ferrari GM
AU  - Gaciong,ZA
AU  - Ceska,R
AU  - Toth,K
AU  - Gouni-Berthold,I
AU  - Lopez-Miranda,J
AU  - Schiele,F
AU  - Mach,F
AU  - Ott,BR
AU  - Kanevsky,E
AU  - Pineda,AL
AU  - Somaratne,R
AU  - Wasserman,SM
AU  - Keech,AC
AU  - Sever,PS
AU  - Sabatine,MS
AU  - FOURIER,Investigators
DO  - 10.1016/S0140-6736(17)32290-0
EP  - 1971
PY  - 2017///
SN  - 0140-6736
SP  - 1962
TI  - Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial
T2  - Lancet
UR  - http://dx.doi.org/10.1016/S0140-6736(17)32290-0
UR  - https://www.sciencedirect.com/science/article/pii/S0140673617322900?via%3Dihub
UR  - http://hdl.handle.net/10044/1/50542
VL  - 390
ER  - 

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