title: Evolocumab lowers LDL-C safely and effectively when self-administered in the at-home setting.
abstract: Evolocumab has been shown to consistently reduce low-density lipoprotein cholesterol (LDL-C) across populations. The phase 3 studies included administration in the home-use and in-clinic settings but did not specifically evaluate the feasibility of home-use administration. Two clinical studies enrolled patients with hypercholesterolemia or mixed dyslipidemia on statin therapy and with/without ezetimibe received evolocumab in the home-use setting. Patients were randomized to self-administer evolocumab using one of two injection devices biweekly over 6 weeks (autoinjector or prefilled syringe; n = 149; ClinicalTrials.gov, NCT01849497) or monthly over 12 weeks (autoinjector or automated minidoser; n = 164; NCT01879319). The first self-administration occurred in the in-clinic setting, and two more were performed in the at-home setting. Patients were successful in self-administering evolocumab in the home-use setting in approximately 95 % of attempts and experienced LDL-C reductions from baseline to week 6 or the mean of weeks 10 and 12 of approximately 65 %. Rates of successful self-administration and LDL-C reduction were similar across dosing schedules and study devices. Adverse events were similar between randomized groups and generally mild in severity. In two clinical studies, therefore, patients were able to successfully self-administer evolocumab in both the in-clinic and at-home settings regardless of which dosing schedule or device they used.
authors.affiliation: Amgen (Europe) GmbH, Dammstrasse 23, 6300 Zug, Switzerland.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Dent
authors.affiliation: Amgen Inc., One Amgen Center Dr, Thousand Oaks, CA 91320 USA.
authors.forename: Raju
authors.initials: R
authors.lastname: Joshi
authors.affiliation: Amgen Inc., One Amgen Center Dr, Thousand Oaks, CA 91320 USA.
authors.forename: C
authors.initials: C
authors.lastname: Stephen Djedjos
authors.affiliation: Amgen Inc., One Amgen Center Dr, Thousand Oaks, CA 91320 USA.
authors.forename: Jason
authors.initials: J
authors.lastname: Legg
authors.affiliation: Amgen Ltd., 240 Cambridge Science Park, Milton, Cambridge, CB4 0WD UK.
authors.forename: Mary
authors.initials: M
authors.lastname: Elliott
authors.affiliation: Amgen Inc., One Amgen Center Dr, Thousand Oaks, CA 91320 USA.
authors.forename: Michelle
authors.initials: M
authors.lastname: Geller
authors.affiliation: Amgen Inc., One Amgen Center Dr, Thousand Oaks, CA 91320 USA.
authors.forename: Dawn
authors.initials: D
authors.lastname: Meyer
authors.affiliation: Amgen Inc., One Amgen Center Dr, Thousand Oaks, CA 91320 USA.
authors.forename: Ransi
authors.initials: R
authors.lastname: Somaratne
authors.affiliation: Centers for Advanced Research and Education, 2350 Limestone Pkwy NE, Gainesville, GA 30501 USA.
authors.forename: Chris
authors.initials: C
authors.lastname: Recknor
authors.affiliation: Maine Research Associates, 2 Great Falls Plaza, Auburn, ME 04210 USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Weiss
keywords: Evolocumab; Home-use; In-clinic; PCSK9 inhibition; Self-administration