Long-Term Evolocumab Safe and Effective for Treating Hypercholesterolemia

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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).
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).

The following article is part of conference coverage from the 2018 AHA Scientific Sessions in Chicago, Illinois.The Cardiology Advisor's staff will be reporting breaking news associated with research conducted by leading experts in cardiology. Check back for the latest news from AHA 2018.

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.

For more coverage of AHA 2018, click here.

Reference

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.

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