Comparison of Cardiotoxicity Induced by Selective Estrogen REceptor Modulators and aNti-Aromatase

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cardiotoxicity of Selective Estrogen Receptor Modulators and Aromatase Inhibitors in the European Pharmacovigilance Database

Conditions
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Cardiac Affections

Intervention / Treatment
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* Drug: Hormonal therapies L02 in the ATC classification


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Hormonal therapies L02 in the ATC classification|Hormonal therapies L02 in the ATC classification|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiotoxicity, selective estrogen receptor modulators, aromatase inhibitors, hormone replacement therapy, estrogen