Long-term lipid lowering with evolocumab further reduces CV events, including CV death by 23%, without a safety signal, according to results from the FOURIEROLE study. ESCCongress
Pivotal statin trials have median follow-up times of 4-5 years and demonstrated both a lag effect, meaning clinical benefit grew over time, and a legacy effect, where clinical benefit persisted in extended follow-up after the parent study, O'Donoghue observed.
Their mean age was 62 years, three fourths were men, a third had diabetes. Three fourths were on a high-intensity statin at the time of enrollment in FOURIER, and median LDL-cholesterol at randomization was 91 mg/dL . Their risk of CV death, MI, or stroke was 20% lower , and, as noted previously, 23% lower for CV death.
Although early studies raised concerns that very low LDL cholesterol may be associated with an increased risk of hemorrhagic stroke and neurocognitive effects, the frequency of adverse events did not increase over time with evolocumab exposure.
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