Long-term treatment with evolocumab plus standard of care (SOC) resulted in sustained high low-density lipoprotein cholesterol (LDL-C) level reduction with no new safety concerns, a new study found. Japanese patients with hypercholesterolemia in the OSLER studies were randomized 2:1 to evolocumab plus SOC or SOC alone for 1 year. After 1 year patients could enter the all-evolocumab plus SOC open-label extension of OSLER. Patients received evolocumab plus SOC from the second year through up to 5 years. Researchers found:
- Of 556 patients, 532 continued to the all-evolocumab plus SOC extension; a total of 91% completed the studies.
- Mean LDL-C change from parent-study baseline with evolocumab from a mean baseline of 142.3 and 105.0 mg/dL in OSLER-1 and OSLER-2, respectively, was maintained through the end of the study.
- The overall safety profile of the evolocumab plus SOC periods was similar to that of the year-1 controlled period.
Hirayama A, Yamashita S, Ruzza A, et al. Long-term treatment with evolocumab among Japanese patients – final report of the OSLER open-label extension studies. [Published online ahead of print March 29, 2019]. Circ J. doi:10.1253/circj.CJ-19-0139.