Evidence mapPaperPMID 39740002Full record

ArticleCancer medicine2025

Cardiovascular and Metabolic Adverse Events of Endocrine Therapies in Women with Breast Cancer: A Disproportionality Analysis of Reports in the FDA Adverse Event Reporting System.

Shaimaa Elshafie, Lorenzo Villa-Zapata, Randall L Tackett, Iman Y Zaghloul, Henry N Young

Abstract read
In one paragraph

Article in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
field-weighted citation impact
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

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Cerebrovascular and Peripheral Vascular Complications in Cancer Patients.Current neurology and neuroscience reports · 2025
    Review
  5. 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

5 authors.

Shaimaa ElshafieDepartment of Clinical and Administrative Pharmacy, College of Pharmacy, University of Georgia, Athens, Georgia, USA.ORCID https://orcid.org/0000-0001-7279-4418
Lorenzo Villa-ZapataDepartment of Clinical and Administrative Pharmacy, College of Pharmacy, University of Georgia, Athens, Georgia, USA.ORCID https://orcid.org/0000-0002-3821-4595
Randall L TackettDepartment of Clinical and Administrative Pharmacy, College of Pharmacy, University of Georgia, Athens, Georgia, USA.
Iman Y ZaghloulSchool of Pharmacy, MCPHS University, Boston, Massachusetts, USA.
Henry N YoungDepartment of Clinical and Administrative Pharmacy, College of Pharmacy, University of Georgia, Athens, Georgia, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEmerging evidence suggests potential cardiovascular toxicities from oral endocrine therapies (ETs); however, results are conflicting. This study comprehensively examined adverse reactions of ETs and investigated cardiovascular and metabolic safety signals within the FDA Adverse Event Reporting System (FAERS).

methodsReports in the FAERS through December 2023 were analyzed for documented reactions to tamoxifen, letrozole, anastrozole, and exemestane in female breast cancer patients. Standardized queries were used to identify cases of cardiovascular (myocardial infarction, heart failure, arrhythmia, stroke) and metabolic (hypertension, dyslipidemia, hyperglycemia) disorders. Descriptive and disproportionality analyses were performed to assess reports and detect safety signals.

resultsAmong 14,327 unique ET-related reports, arthralgia (n = 1873 events) was the most prevalent reaction. We identified 2170 cardiovascular and 2252 metabolic events associated with ETs. Letrozole had the highest reporting rate of cardiac arrhythmia (7.7%) and showed positive signals for both arrhythmia (reporting odds ratio [ROR] = 2.2; 95% confidence interval [CI]: 1.8-2.5) and myocardial infarction (ROR = 1.9; 95% CI: 1.4-2.6). We also observed a significantly increased risk of heart failure with letrozole (ROR = 1.3; 95% CI: 1.1-1.6) and stroke with tamoxifen (ROR = 1.7; 95% CI: 1.5-2.1). Only anastrozole was significantly associated with metabolic dysfunctions with a notable hyperglycemia reporting rate of 12.2%.

conclusionOur findings provide valuable evidence on common reactions as well as controversial cardiovascular and metabolic abnormalities associated with the real-world use of ETs for breast cancer. Ongoing benefit-risk assessment and close monitoring of cardiac function during treatment, particularly in high-risk women, are warranted to optimize cancer outcomes while minimizing cardiovascular injury.

Indexed as

Adverse Drug Reaction Reporting SystemsAntineoplastic Agents, HormonalBreast NeoplasmsCardiovascular DiseasesUnited States Food and Drug AdministrationAdultAgedFemaleHumansMetabolic DiseasesMiddle AgedUnited StatesAntineoplastic Agents, Hormonaladverse drug reactionsbreast cancercardiovascular riskdisproportionality analysisendocrine therapyFAERS database

Identifiers

PMID39740002
PMCPMC11683672

What Socratic 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 Socratic graph.