| Autor: |
Yong Huo, Beijian Chen, Qiufang Lian, Shuqing Wang, Lu Liu, Di Lu, Yanling Qu, Guanzhong Zheng, Lipeng Li, Yuan Ji, Guotian Yin, Wenjun Huang, Ying Xie, Xinchun Yang, Xiufang Gao, Pei An, Fengtai Xue, Haoyu Li, Huan Deng, Li Li, Lijuan Pei, Lei Qian |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Předmět: |
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| Zdroj: |
The Lancet Regional Health. Western Pacific, Vol 41, Iss , Pp 100907- (2023) |
| Druh dokumentu: |
article |
| ISSN: |
2666-6065 |
| DOI: |
10.1016/j.lanwpc.2023.100907 |
| Popis: |
Summary: Background: Tafolecimab, a fully human proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody developed for the treatment of hypercholesterolemia, demonstrated robust lipid-lowering efficacy and favorable safety in previous short-term studies. We aimed to assess the long-term efficacy and safety of tafolecimab in Chinese non-familial hypercholesterolemia (non-FH) patients. Methods: Non-FH patients at high or very-high cardiovascular risk with screening low-density lipoprotein cholesterol (LDL-C) level ≥1.8 mmol/L or non-FH patients with screening LDL-C level ≥3.4 mmol/L and on stable lipid-lowering therapy for at least 4 weeks, were randomized in a 2:2:1:1 ratio to receive subcutaneous tafolecimab 450 mg Q4W, tafolecimab 600 mg Q6W, placebo 450 mg Q4W, or placebo 600 mg Q6W, respectively, in the 48-week double-blind treatment period. The primary endpoint was the percent change from baseline to week 48 in LDL-C levels. Findings: A total of 618 patients were randomized and 614 patients received at least one dose of tafolecimab (n = 411) or placebo (n = 203). At week 48, tafolecimab induced significant reductions in LDL-C levels (treatment differences versus placebo [on-treatment estimand]: −65.0% [97.5% CI: −70.2%, −59.9%] for 450 mg Q4W; −57.3% [97.5% CI: −64.0%, −50.7%] for 600 mg Q6W; both P |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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