Evidence mapPaperPMID 37614541Full record

ArticleJACC. Asia2023

Tafolecimab in Chinese Patients With Hypercholesterolemia (CREDIT-4): A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial.

Litong Qi, Dexue Liu, Yanling Qu, Beijian Chen, Haiyan Meng, Lei Zhu, Lipeng Li, Shuqing Wang, Changyi Liu, Guanzhong Zheng and 12 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in JACC. Asia, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04709536 (A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of IBI306 in Patients With Hypercholesterolemia in China), which is not on this map. Cited by 25 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 3 pooled it
8.9field-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.

NCT04709536 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of IBI306 in Patients With Hypercholesterolemia in China (CREDIT-4)

TypeinterventionalSponsorInnovent Biologics (Suzhou) Co. Ltd.Ran2021 to 2022Enrolled306ConditionsHypercholesterolemiaArmsIBI306, Placebo
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 3 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. The Efficacy of Tafolecimab in Chinese Patients with Hypercholesterolemia: A Systematic Review and Meta-analysis.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2024
    Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Antibody-Based Therapeutics for Hypercholesterolemia.Biologics : targets & therapy · 2025
    Review
  16. Article
  17. Article
  18. Review
  19. Review
  20. 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.

Litong QiDepartment of Cardiology, Peking University First Hospital, Beijing, China.
Dexue LiuDepartment of Endocrinology, The First Affiliated Hospital of Nanyang Medical College, Nanyang, China.
Yanling QuDepartment of Cardiology, Yuncheng Central Hospital of Shanxi Province, Yuncheng, China.
Beijian ChenDepartment of Cardiology, Heze Municipal Hospital, Heze, China.
Haiyan MengDepartment of Cardiology, Shandong Provincial Third Hospital, Jinan, China.
Lei ZhuDepartment of Cardiology, Shandong Provincial Third Hospital, Jinan, China.
Lipeng LiDepartment of Cardiology, Luoyang Third People's Hospital, Luoyang, China.
Shuqing WangDepartment of Cardiology, The First Hospital of Qiqihar City, Qiqihar, China.
Changyi LiuDepartment of Cardiology, The First Hospital of Qiqihar City, Qiqihar, China.
Guanzhong ZhengDepartment of Cardiology, Zibo Municipal Hospital, Zibo, China.
Qiufang LianDepartment of Cardiology, Yan'an University Xianyang Hospital, Xianyang, China.
Guotian YinDepartment of Cardiology, The Third Affiliated Hospital of Xinxiang Medical College, Xinxiang, China.
Lingchun LvDepartment of Cardiology, Lishui Central Hospital, Lishui, China.
Di LuDepartment of Cardiology, China National Petroleum Corporation Central Hospital, Langfang, China.
Xiaoshu ChenDepartment of Cardiology, Wenzhou People's Hospital, Wenzhou, China.
Fengtai XueInnovent Biologics, Inc, Suzhou, China.
Pei AnInnovent Biologics, Inc, Suzhou, China.
Haoyu LiInnovent Biologics, Inc, Suzhou, China.
Huan DengInnovent Biologics, Inc, Suzhou, China.
Li LiInnovent Biologics, Inc, Suzhou, China.
Lei QianInnovent Biologics, Inc, Suzhou, China.
Yong HuoDepartment of Cardiology, Peking University First Hospital, Beijing, China.
Shandong Provincial Hospital · CNQiqihar Medical University · CNThird People 's Hospital of Liaoyang · CNCentral Hospital of Zibo · CNChina National Petroleum Corporation (China) · CNHeze Municipal Hospital · CNLishui Central Hospital · CNNanyang Medical College · CNPeking University · CNPeking University First Hospital · CNWenzhou City 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 is a novel fully human proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody, developed for the treatment of hypercholesterolemia. Objectives: The purpose of this study was to assess the efficacy and safety of tafolecimab in Chinese patients at high or very high cardiovascular risk with hypercholesterolemia. Methods: Patients with diagnoses of heterozygous familial hypercholesterolemia (HeFH) by the Simon Broome criteria or at high or very high cardiovascular risk with nonfamilial hypercholesterolemia, with screening low-density lipoprotein cholesterol (LDL-C) level ≥1.8 mmol/L, were randomized 2:1 to receive tafolecimab or placebo 450 mg every 4 weeks (Q4W) in the 12-week double-blind treatment period. The primary endpoint was the percent change from baseline to week 12 in LDL-C levels. Results: A total of 303 patients were enrolled and received at least 1 dose of tafolecimab (n = 205) or placebo (n = 98). The least squares mean percent change in LDL-C level from baseline to week 12 was -68.9% (SE 1.4%) in the tafolecimab group and -5.8% (1.8%) in the placebo group (difference: -63.0%; [95% CI: -66.5% to -59.6%]; Conclusions: Tafolecimab was safe and showed robust lipid-lowering efficacy in Chinese patients at high or very high cardiovascular risk with hypercholesterolemia. (A Study of IBI306 in Participants With Hypercholesterolemia; NCT04709536).

Indexed as

coronary artery diseasehypercholesterolemialow-density lipoprotein cholesteroltafolecimab

Identifiers

PMID37614541
PMCPMC10442872
OpenAlexW4383896988

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.