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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Xu, Mingtong Zhu, Xiaoxue Wu, Junyan Zhang, Yuling Zhao, Dong Wang, Xuhong Ding, Yanhua Cao, Yu Li, Chengqian Hu, Wei Sheng, Jianlong Luo, Zhu Zheng, Zeqi Hu, Jinfang Liu, Jianying Zhou, Xiaoyang Shen, Aizong Ding, Xiaomei Zhang, Yongdong Zhao, Yonggang Li, Yijing Zhong, Sheng An, Shimin Zou, Jianjun Yan, Li |
| Abstract | Background Recaticimab (SHR-1209, a humanized monoclonal antibody against PCSK9) showed robust LDL-C reduction in healthy volunteers. This study aimed to further assess the efficacy and safety of recaticimab in patients with hypercholesterolemia. Methods In this randomized, double-blind, placebo-controlled phase 1b/2 trial, patients receiving stable dose of atorvastatin with an LDL-C level of 2.6 mmol/L or higher were randomized in a ratio of 5:1 to subcutaneous injections of recaticimab or placebo at different doses and schedules. Patients were recruited in the order of 75 mg every 4 weeks (75Q4W), 150Q8W, 300Q12W, 150Q4W, 300Q8W, and 450Q12W. The primary endpoint was percentage change in LDL-C from the baseline to end of treatment (i.e., at week 16 for Q4W and Q8W schedule and at week 24 for Q12W schedule). Results A total of 91 patients were enrolled and received recaticimab and 19 received placebo. The dose of background atorvastatin in all 110 patients was 10 or 20 mg/day. The main baseline LDL-C ranged from 3.360 to 3.759 mmol/L. The least-squares mean percentage reductions in LDL-C from baseline to end of treatment relative to placebo for recaticimab groups at different doses and schedules ranged from −48.37 to −59.51%. No serious treatment-emergent adverse events (TEAEs) occurred. The most common TEAEs included upper respiratory tract infection, increased alanine aminotransferase, increased blood glucose, and increased gamma-glutamyltransferase. Conclusion Recaticimab as add-on to moderate-intensity statin therapy significantly and substantially reduced the LDL-C level with an infrequent administration schedule (even given once every 12 weeks), compared with placebo. Trial registration ClinicalTrials.gov , number NCT03944109 |
| Related Links | https://bmcmedicine.biomedcentral.com/counter/pdf/10.1186/s12916-021-02208-w.pdf |
| Ending Page | 13 |
| Page Count | 13 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| ISSN | 17417015 |
| DOI | 10.1186/s12916-021-02208-w |
| Journal | BMC Medicine |
| Issue Number | 1 |
| Volume Number | 20 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2022-01-18 |
| Access Restriction | Open |
| Subject Keyword | Medicine Public Health Biomedicine PCSK9 Hypercholesterolemia Recaticimab Infrequent administration Medicine/Public Health |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine |
| Journal Impact Factor | 7.1/2023 |
| 5-Year Journal Impact Factor | 8.8/2023 |
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