부산대학교 도서관

Background:The PCSK9 inhibitor alirocumab has shown significant low-density lipoprotein cholesterol (LDL-C) reductions at a dose of 300 mg every 4 weeks (Q4W), administered as 2 150 mg injections via 1 mL autoinjector (AI). A new 2 mL device (SYDNEY) has been developed to permit a single 300 mg alirocumab injection.Objectives:To assess usability and Product Technical Complaints (PTCs) reported by patients using the 2 mL SYDNEY in unsupervised settings, as well as effects on LDL-C and safety.Methods:A multicenter, randomized, open-label, 16 week (W) study conducted in the US. Patients with hypercholesterolemia despite statin ? other lipid-lowering therapy were randomized (n=69) to receive supervised, self-administered alirocumab 300 mg via 1 injection with SYDNEY (n=35) or 2 injections with the approved AI (n=34) for the first dose at W0. All patients then received unsupervised, self-administered alirocumab 300 mg Q4W via SYDNEY at W4, 8 and 12. The primary endpoint was the proportion of PTCs from the unsupervised injections.Results:Baseline characteristics were similar between arms, except for a higher percentage of males in the SYDNEY versus AI arm (Table). A single PTC was reported from the unsupervised injections (0.5%; 1 of 196; 95% CI: 0.0% to 3.2%) and classified as patient-related as opposed to device-related; no PTC were reported during supervised injections (Table). LDL-C reductions from baseline at W4 were 66.2% with SYDNEY and 51.2% with AI. LDL-C reductions were 63.5% and 53.9%, respectively, after adjustment for sex differences between groups. LDL-C reductions were maintained over 16W. Safety results for W0-W4 are shown in the Table; the most common adverse events were upper and lower respiratory tract infections (5 with SYDNEY, 1 with AI).Conclusions:SYDNEY device allowed for a single 2 mL injection of alirocumab 300 mg, providing large LDL-C reductions with no product technical issues or safety concerns compared with the current AI device.