Sydney Device Study: A Multicenter, Randomized, Open-label Usability Study of a New 2 Ml Alirocumab Autoinjector Device

Clinical Therapeutics(2019)

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摘要
The SYDNEY device allowed for a single 2-mL injection of alirocumab 300 mg, providing substantial LDL-C reductions with no new product technical issues or no new safety concerns compared with the currently marketed 1-mL AI device. In conclusion, the 2-mL SYDNEY device provides patients with the possibility of injecting the 300-mg alirocumab dose as a single injection. ClinicalTrials.gov identifier: NCT03415178 (Clin Ther. 2019; XX:XXX-XXX) © 2019 Elsevier HS Journals, Inc.
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关键词
alirocumab,autoinjector,device usability,PCSK9 inhibitor,self-administration,SYDNEY device
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