CardioTOxicity Induced by andRogeNICS and Their Antagonists (TORNICS)

Groupe Hospitalier Pitie-Salpetriere

Status: Completed

Conditions: Heart Diseases

Treatments: Drug: Hormonal therapies: G03, H01C and L02 in the ATC classification

Study type: Observational

Funder types: Other

Identifiers

NCT03193138

CIC1421-17-06

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 3,096 patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Case reported in the French pharmacovigilance database and EudraCT database from 01/01/1985 to 14/04/2017
• Adverse event reported were including the MedDRA terms: SOC Cardiac Affections and the HLT Death and Sudden Death
• Patients treated with hormonal therapies included in the ATC classification references: G03, H01C and L02

Exclusion criteria

• Chronology not compatible between the drug and the toxicity