Evidence mapPaperPMID 37808342Full record

ArticleThe Lancet regional health. Western Pacific2023

Tafolecimab in Chinese patients with non-familial hypercholesterolemia (CREDIT-1): a 48-week randomized, double-blind, placebo-controlled phase 3 trial.

Yong Huo, Beijian Chen, Qiufang Lian, Shuqing Wang, Lu Liu, Di Lu, Yanling Qu, Guanzhong Zheng, Lipeng Li, Yuan Ji and 12 more

Open access · goldAbstract read
In one paragraph

Article in The Lancet regional health. Western Pacific, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 3 pooled it
8.6field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 3 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Review
  6. Article
  7. Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Antibody-Based Therapeutics for Hypercholesterolemia.Biologics : targets & therapy · 2025
    Review
  17. Article
  18. Review
  19. Review
  20. Dyslipidemia: A Narrative Review on Pharmacotherapy.Pharmaceuticals (Basel, Switzerland) · 2024
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 14 institutions in 1 country.

Yong HuoDepartment of Cardiology, Peking University First Hospital, Beijing, China.
Beijian ChenDepartment of Cardiology, Heze Municipal Hospital, Heze, China.
Qiufang LianDepartment of Cardiology, Yan'an University Xianyang Hospital, Xianyang, China.
Shuqing WangDepartment of Cardiology, The First Hospital of Qiqihar City, Qiqihar, China.
Lu LiuDepartment of Cardiology, The First Hospital of Qiqihar City, Qiqihar, China.
Di LuDepartment of Cardiology, China National Petroleum Corporation Central Hospital, Langfang, China.
Yanling QuDepartment of Cardiology, Yuncheng Central Hospital of Shanxi Province, Yuncheng, China.
Guanzhong ZhengDepartment of Cardiology, Zibo Municipal Hospital, Zibo, China.
Lipeng LiDepartment of Cardiology, Luoyang Third People's Hospital, Luoyang, China.
Yuan JiDepartment of Cardiology, Changzhou Second People's Hospital, Changzhou, China.
Guotian YinDepartment of Cardiology, The Third Affiliated Hospital of Xinxiang Medical College, Xinxiang, China.
Wenjun HuangDepartment of Cardiology, Pingxiang People's Hospital, Pingxiang, China.
Ying XieDepartment of Cardiology, Beijing Tsinghua Changgung Hospital, Beijing, China.
Xinchun YangDepartment of Cardiology, Beijing Chaoyang Hospital, Beijing, China.
Xiufang GaoDepartment of Cardiology, Huashan Hospital Affiliated to Fudan University, Shanghai, China.
Pei AnInnovent Biologics, Inc., Suzhou, China.
Fengtai XueInnovent Biologics, Inc., Suzhou, China.
Haoyu LiInnovent Biologics, Inc., Suzhou, China.
Huan DengInnovent Biologics, Inc., Suzhou, China.
Li LiInnovent Biologics, Inc., Suzhou, China.
Lijuan PeiInnovent Biologics, Inc., Suzhou, China.
Lei QianInnovent Biologics, Inc., Suzhou, China.
Qiqihar Medical University · CNThird People 's Hospital of Liaoyang · CNBeijing Chaoyang Emergency Medical Center · CNBeijing Tsinghua Chang Gung Hospital · CNCentral Hospital of Zibo · CNChina National Petroleum Corporation (China) · CNFudan University · CNHeze Municipal Hospital · CNJiangxi Pingxiang People's Hospital · CNPeking University · CNTaizhou Second People's Hospital · CNXianyang Normal University · CNXinxiang Medical University · CNYuncheng University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 Interpretation: Tafolecimab dosed at 450 mg Q4W and 600 mg Q6W was safe and showed superior lipid-lowering efficacy versus placebo, providing a novel treatment option for Chinese hypercholesterolemia patients. Funding: This study was sponsored by Innovent Biologics, Inc.

Indexed as

Cardiovascular diseaseHypercholesterolemiaLow-density lipoprotein cholesterolTafolecimab

Identifiers

PMID37808342
PMCPMC10558773
OpenAlexW4387149446

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.