Identification of Anticancer Drugs Associated With Cancer Therapy-related Cardiac Dysfunction: a WHO Pharmacovigilance Database
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- University Hospital, Caen
- Enrollment
- 36580288
- Locations
- 1
- Primary Endpoint
- Disproportionality individual case data analysis between heart failure of cardiac dysfunction and cancer therapies
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Case reported in the World Health Organization (WHO) database of individual safety case reports to 29/02/2024
- •Patients treated with FDA and/or EMA approved cancer therapies (approval the 30th September 2023).
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Disproportionality individual case data analysis between heart failure of cardiac dysfunction and cancer therapies
Time Frame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2024
A disproportionality analysis is carried out using stepwise selection procedure and taking into account confounding factors (factors known to promote heart failure or cardiac dysfunction).
Secondary Outcomes
- 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 March 2024)
- Description of the population of patients having a heart failure of cardiac dysfunction event with cancer therapies(Case reported in the World Health Organization (WHO) of individual safety case reports to March 2024)
- Description of the drug-drug interactions associated with adverse events(Case reported in the World Health Organization (WHO) of individual safety case reports to March 2024)