Long-Term Evolocumab Safe and Effective for Treating Hypercholesterolemia
Adverse events leading to drug discontinuation occurred in 2.8%, 0.8%, 1.3%, 1.0% and 0.2% of patients each year (years 1-5).
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CHICAGO — Long-term evolocumab consistently reduced low-density lipoprotein cholesterol (LDL-C) while diminishing the incidence of adverse events in patients with cardiovascular disease. This research was presented at the Scientific Sessions of the American Heart Association, held November 10-12, 2018. Furthermore, no new neutralizing anti-drug antibodies were detected.
Investigators of this study sought to evaluate the long-term efficacy and safety data of evolocumab therapy in patients with hypercholesterolemia. The study population included 1324 patients entered in the OSLER-1 trial (ClinicalTrials.gov Identifier: NCT01439880), and who had previously completed 1 double-blind, controlled study of evolocumab.
For 1 year, participants were randomly assigned to receive open-label evolocumab 420 mg monthly with standard of care (n=882) or standard of care alone (n=442). After 1 year, 1255 participants continued with extended evolocumab therapy and standard of care, for which the therapeutic effect on lipid levels and the safety of evolocumab were assessed over a period of up to 5 years.
The study results showed that evolocumab reduced median LDL-C levels in a significant proportion of the sample each year of the study: 61% (n=818) reported reduced LDL-C at year 1, 59% (n=1122) at year 2, 59% (n=1059) at year 3, 59% (n=1012) at year 4, and 58% (n=870) at year 5. Adverse events related to evolocumab treatment were reported by 79% of the sample at year 1, 74% at year 2, 71% at year 3, 67% at year 4, and 65% at year 5, indicating a reduction of adverse events over time. Serious adverse events were reported in 7% of the participants for every year except year 3 (8%).
Only 2 standard of care and 2 evolocumab participants tested positive for neutralizing anti-drug antibodies in the first year.
The investigators found that long-term evolocumab use consistently reduced LDL-C levels in patients with hypercholesterolemia; furthermore, safety results showed that evolocumab was not associated with an increase in adverse events over time or neutralizing antibodies.
Disclosure: Multiple authors declare associations with the pharmaceutical industry. Please see original reference for a full list of authors' disclosures.
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Koren MJ, Sabatine MS, Giugliano RP, et al. Final report of the OSLER-1 study: long-term evolocumab for the treatment of hypercholesterolemia. Presented at: AHA 2018; November 10-12, 2018; Chicago, Illinois. Abstract 118.