Identification of Anticancer Drugs Associated With Heart Failure: a WHO Pharmacovigilance Database Analysis

Identification of Anticancer Drugs Associated With Heart Failure: a WHO Pharmacovigilance Database

Therapeutic advances have significantly improved the survival of patients with cancer. However, these novel therapies are associated with a concomitant increase in the prevalence of toxicity, including cardiovascular complications of cancer therapy.

Among these adverse drug reactions, heart failure and, more generally, cancer therapy-related cardiac dysfunction are the most concerning cardiovascular complications of cancer therapy, carrying a high morbidity burden and an elevated risk of death.

Patients with both heart failure and cancer have a worse prognosis when compared with heart failure patients with no history of cancer. It is therefore crucial to enhance the identification of patients at a higher risk of cancer therapy-related cardiac dysfunction both before and during treatment, especially when utilizing cancer therapies with known potential cardiovascular adverse drug reactions.

The explosion of new anticancer drugs has led to the potential association of these therapies with cardiac dysfunction.

Using VigiBase, the World Health Organization's (WHO) global pharmacovigilance database, the investigators aimed to assess the relationship between cancer therapy-related cardiac dysfunction and the administration of anti-cancer drugs.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Cancer, Therapy-Related
• Intervention / Treatment: Drug: Cancer therapy with FDA and/or EMA approval on the 31st March 2022

• Study Type: Observational
• Enrollment (Actual): 3406383

Contacts and Locations

Study Locations

• France
  • Caen, France
    • CAEN University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Every patients in the World Health Organization (WHO) database of individual safety case reports to 01/04/2022 included with at least one anticander drug.

Description

Inclusion Criteria:

• Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/04/2022
• Patients treated with FDA and/or EMA approved cancer therapies (approval the 31st March 2023).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disproportionality individual case data analysis between heart failure of cardiac dysfunction and cancer therapies	A disproportionality analysis is carried out in multivariate analysis taking into account confounding factors (factors known to promote heart failure or cardiac dysfunction).	Case reported in the World Health Organization (WHO) of individual safety case reports to September 2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the population of patients having a heart failure of cardiac dysfunction event with cancer therapies	The investigators describe the profile of cases of heart failure of cardiac dysfunction among cancer therapies associated with heart failure or cardiac dysfunction in the main analysis. We particularly focused on factors known to promote heart failure.	Case reported in the World Health Organization (WHO) of individual safety case reports to September 2023
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed		Case reported in the World Health Organization (WHO) of individual safety case reports to September 2023
Description of the drug-drug interactions associated with adverse events		Case reported in the World Health Organization (WHO) of individual safety case reports to September 2023

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Neoplasms; Heart Failure; Neoplasms, Second Primary
• Other Study ID Numbers: CaenUH_DL_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No