Latest efficacy studies support use of Amgen's Repatha in conjunction with statin

THOUSAND OAKS, Calif. — Amgen on Monday announced a new analysis from the Repatha (evolocumab) cardiovascular outcomes study (FOURIER) that showed a statistically significant relationship between lower achieved low-density lipoprotein cholesterol (LDL-C) levels and lower cardiovascular event rates in patients with established atherosclerotic cardiovascular disease.



There was no evidence of a leveling off of effect and no new safety concerns were identified in this analysis. The results were presented in a Late-Breaking Clinical Trials session at the European Society of Cardiology Congress 2017 in Barcelona, Spain and simultaneously published in The Lancet.



"With this analysis, we've further demonstrated the safety and efficacy of achieving an LDL-C well below current targets," stated Robert Giugliano, Brigham and Women's Hospital and Harvard Medical School, Boston and lead author on the analysis. "These findings from the first analysis of a large cohort of patients to achieve such ultra-low LDL-C levels support the use of intensive lipid-lowering therapies, such as the combination of evolocumab and statin therapy, in high-risk patients to safely reduce the risk of another cardiovascular event."



Approximately 26,000 patients from the Repatha cardiovascular outcomes study were followed for a median of 2.2 years. Rates for the primary and secondary composite endpoints and cognitive function testing, as well as safety events, including cancer, hemorrhagic stroke, new onset diabetes, cataract, neurocognitive dysfunction and non-cardiovascular death were compared across five groups.



"Scientific evidence demonstrating the strong progressive association between lowering LDL-C and the risk reduction of cardiovascular events in patients with established atherosclerotic cardiovascular disease continues to grow," said Sean Harper, EVP research and development at Amgen. "For patients who have already experienced an event, such as a heart attack or stroke, this analysis reinforces that the intensive LDL-C lowering provided with Repatha helps patients reduce their risk of another cardiovascular event."