The results of the trial were presented at the 2017 American College of Cardiology Scientific Sessions on March 17, 2017 and simultaneously published in the New England Journal of Medicine.
«The use of evolocumab, in combination with statin therapy, effectively lowered LDL cholesterol down to a median of 30 mg/dL and resulted in clinically meaningful benefits that increased the longer patients received the therapy," said lead researcher Marc S. Sabatine, MD, MPH, chairman of the TIMI Study Group at Brigham and Women’s Hospital.
In this randomized,
Similar to data from previous lipid lowering trials, researchers report that evolocumab reduced LDL cholesterol by 59 percent, in this case from a median of 92 mg/dL to a median of 30 mg/dL. The LDL cholesterol lowering effect remained constant over the duration of the trial.
Researchers report that patients treated with evolocumab had a 15 percent reduction in the risk of major cardiovascular events, defined as the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization (occurring in 9.8 percent of patients treated with evolocumab vs. 11.3 percent of patients treated with placebo). Additionally, evolocumab reduced the more serious key secondary endpoint, which was a composite of heart attack, stroke or cardiovascular death, by 20 percent (occurring in 7.9 percent of patients treated with evolocumab vs. 9.9 percent in the placebo group). This reduction in risk improved over time, increasing from 16 percent in the first year to 25 percent after the first year.
«Importantly, the reduction in events was consistent across all key subgroups, including age, sex, type of disease and statin intensity," said Sabatine, who is also the Lewis Dexter, MD, Distinguished Chair in Cardiovascular Medicine at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School.
The data also show similar clinical benefit with evolocumab when analyzed according to baseline LDL levels, even in patients in the lowest quartile of baseline LDL cholesterol, in whom evolocumab reduced LDL cholesterol from 73 to 22 mg/dL.
«These data show that lowering LDL cholesterol beyond current treatment targets confers significant benefits for our patients with cardiovascular disease who are at a high risk of cardiovascular events," said Sabatine. «Given these findings, patients with cardiovascular disease should review their LDL cholesterol with their physicians and discuss whether it should be lowered beyond what they have achieved with diet, lifestyle modifications and statin therapy.»
Researchers report no difference in adverse safety events between the two groups including rates of
Evolocumab is a fully human monoclonal antibody that works by blocking proprotein convertase
The trial was designed in a collaboration between the Executive Committee and the trial sponsor, Amgen, which manufactures evolocumab and provided a research grant to the TIMI Study Group at BWH. The TIMI Study Group conducted all data analyses presented in the paper. Sabatine and the TIMI Study Group receive research grants from various pharmaceutical companies that produce other