Cardiac Affections
Conditions
Keywords
Cardiotoxicity, selective estrogen receptor modulators, aromatase inhibitors, hormone replacement therapy, estrogen
Brief summary
Selective estrogen receptor modulators and aromatase inhibitors for the treatment of breast 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: L02 in the European pharmacovigilance database, Eudravigilance.
Detailed 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. 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 L02 according to ATC.
Interventions
DRUGHormonal therapies L02 in the ATC classification
Hormonal therapies L02 in the ATC classification
Sponsors
Groupe Hospitalier Pitie-Salpetriere
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Case reported in the Eudravigilance from 01/2002 to 08/2017 * Adverse event reported were including the MedDRA terms: SOC Cardiac Affections and the HLT Death and Sudden Death
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis of disproportionality of reports for cardiotoxicity associated with selective estrogen receptor modulators as compared to aromatase inhibitors by performing a case- non-case study | Immediate evaluation |
Secondary
| Measure | Time frame |
|---|---|
| Type of cardiotoxicity (ventricular arrhythmia's, QT prolongation and Torsade de Pointe) depending on the category and type of hormonal therapy (selective estrogen receptor modulators or aromatase inhibitors) | Immediate evaluation |
| Disproportionality analysis of the reporting of drug-induced ventricular arrhythmia's with selective estrogen receptor modulators as compared to aromatase inhibitors | Immediate evaluation |
| Disproportionality analysis of the reporting of drug- induced QT prolongation with selective estrogen receptor modulators as compared to aromatase inhibitors | Immediate evaluation |
| Disproportionality analysis of the reporting of drug-induced Torsade de Pointe with selective estrogen receptor modulators as compared to aromatase inhibitors | Immediate evaluation |
Countries
France
Outcome results
None listed