Anti-androgenic therapies relying on peripheral and/or central blockade for the treatment of prostate cancer seems to have an impact on the cardio-vascular system. This study investigates reports of cardiovascular toxicities for treatment including Anatomical Therapeutic Chemical (ATC) classification: sex hormones (G03), hypothalamic hormones (H01C) and sex hormones used in treatment of neoplastic diseases (L02) in the French pharmacovigilance database and European Clinical Trials (EudraCT) database.
Hormone replacement therapies and contraceptive pills are responsible of a wide range of cardio-vascular side effects, particularly thrombo-embolic disorders and ischemic heart disease. The difference of incidence and type of cardio-vascular events between men and women are strongly related to sex hormones. Androgenic agonists and antagonists are used in various indication including prostate cancer or hormone replacement therapies. This study investigates the main characteristics of patients affected by cardiovascular side effects (of which ventricular arrhythmia's, QT prolongation and Torsade de Pointe) imputed to drugs classified as G03, H01C and L02 according to ATC. A causality assessment according to both Begaud's method and the World Health Organization-The Uppsala Monitoring Centre (WHO-UMC) is systematically applied.
Study Type
OBSERVATIONAL
Enrollment
3,096
Hormonal therapies including all therapies classified G03, H01C and L02 in the ATC classification
Centre Régional de Pharmaco-vigilance - Paris, Pitié-Salpétrière
Paris, Île-de-France Region, France
Identification and report of the cardio-vascular toxicity of anti-androgenic therapies (reference G03 in the ATC classification) with a causality assessment using Begaud's and WHO's method.
The research includes the report with MedDRA terms: System Organ Class (SOC) Cardiac Disorders and High Level Term (HLT) Death and Sudden Death. Drugs investigated are hormonal therapies with the reference G03 in the ATC classification
Time frame: Immediate evaluation
Identification and report of the cardio-vascular toxicity of anti-androgenic therapies (reference H01C in the ATC classification) with a causality assessment using Begaud's and WHO's method.
The research includes the report with MedDRA terms: System Organ Class (SOC) Cardiac Disorders and High Level Term (HLT) Death and Sudden Death. Drugs investigated are hormonal therapies with the reference H01C in the ATC classification
Time frame: Immediate evaluation
Identification and report of the cardio-vascular toxicity of anti-androgenic therapies (reference L02 in the ATC classification) with a causality assessment using Begaud's and WHO's method.
The research includes the report with MedDRA terms: System Organ Class (SOC) Cardiac Disorders and High Level Term (HLT) Death and Sudden Death. Drugs investigated are hormonal therapies with the reference L02 in the ATC classification
Time frame: Immediate evaluation
Causality assessment of reported cardiovascular events
Causality assessment of reported cardiovascular events according to the WHO-UMC system
Time frame: Immediate evaluation
Type of cardiotoxicity depending on the category and type of hormonal therapy
Description of the type of cardiotoxicity depending on the category and type of hormonal therapy
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Time frame: Immediate evaluation
Duration of treatment when the toxicity happens
Description of the duration of treatment when the toxicity happens (role of cumulative dose)
Time frame: Immediate evaluation
Drug-drug interactions associated with adverse events
Description of the drug-drug interactions associated with adverse events (particularly heart failure, ischemic heart disease and cardiac arrhythmia's)
Time frame: Immediate evaluation
Pathologies for which the incriminated drugs have been prescribed
Description of the pathologies (cancer, hormonal insufficiency) for which the incriminated drugs have been prescribed
Time frame: Immediate evaluation
Population of patients having a cardio-vascular adverse event
Description of the population of patients having a cardio-vascular adverse event
Time frame: Immediate evaluation