Evidence map›Paper›PMID 35140810›Full record

ArticleCardiovascular therapeutics2022

Musculoskeletal Adverse Events Associated with PCSK9 Inhibitors: Disproportionality Analysis of the FDA Adverse Event Reporting System.

Lingqing Ding, Congqin Chen, Yongkuan Yang, Jie Fang, Longxing Cao, Yige Liu

Open access · goldAbstract read
In one paragraph

Article in Cardiovascular therapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.3field-weighted citation impact, top 8% 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

12 citing papers in PubMed, 16 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Review
  9. Postmarket safety profile of suicide/self-injury for GLP-1 receptor agonist: a real-world pharmacovigilance analysis.European psychiatry : the journal of the Association of European Psychiatrists · 2023
    Article
  10. Article
  11. Article
  12. Article
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

6 authors at 3 institutions in 1 country.

Lingqing DingDepartment of Pharmacy, Xiamen Cardiovascular Hospital, Xiamen University, Xiamen 361024, China.ORCID https://orcid.org/0000-0002-4767-9933
Congqin ChenDepartment of Pharmacy, Xiamen Cardiovascular Hospital, Xiamen University, Xiamen 361024, China.ORCID https://orcid.org/0000-0003-1768-1298
Yongkuan YangSchool of Electrical Engineering and Automation, Xiamen University of Technology, Xiamen 361024, China.ORCID https://orcid.org/0000-0002-8216-4767
Jie FangDepartment of Pharmacy, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200003, China.ORCID https://orcid.org/0000-0002-2099-6648
Longxing CaoDepartment of Cardiovascular Medicine, Xiamen Cardiovascular Hospital, Xiamen University, Xiamen 361024, China.ORCID https://orcid.org/0000-0002-1006-8223
Yige LiuDepartment of Pharmacy, Xiamen Cardiovascular Hospital, Xiamen University, Xiamen 361024, China.ORCID https://orcid.org/0000-0002-0093-6269
First Affiliated Hospital of Xiamen University · CNShanghai Jiao Tong University · CNXiamen University of Technology · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSome studies suggest that potential safety issues about PCSK9 inhibitors have not been sufficiently explored in clinical trials, including musculoskeletal adverse events (MAEs).

objectiveTo examine the association between use of PCSK9 inhibitors with and without concurrent statins and risk of MAEs.

results3,185 cases of PCSK9 inhibitor-associated MAEs were recorded. PCSK9 inhibitor class alone demonstrated a strong link to MAEs (ROR 5.92; 95% CI 5.70-6.15), and evolocumab was associated with more reports of MAEs than alirocumab. Concomitant use with statins leaded to an increased occurrence of MAEs (ROR 32.15 (25.55-40.46)), and the risk differed among different statins. The PCSK9 inhibitors were safer than statins in terms of hospitalization rate and death rate (15.64% vs. 36.83%; 0.72% vs. 3.53%).

conclusionsThis pharmacovigilance investigation suggests that PCSK9 inhibitors are associated with MAEs. The risk significantly increases when combined with statins. Increased laboratory and clinical monitoring are required to timely diagnose and manage MAEs.

Indexed as

PCSK9 InhibitorsProprotein Convertase 9Adverse Drug Reaction Reporting SystemsHumansPharmacovigilancePCSK9 InhibitorsPCSK9 protein, humanProprotein Convertase 9

Identifiers

PMID35140810
PMCPMC8808238
OpenAlexW4206987057

What OpenQuestion holds

Textmetadata
LicenceCC BY
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 OpenQuestion graph.