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

Groupe Hospitalier Pitie-Salpetriere20,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

20,000

Conditions

Cardiac Affections

Interventions

Hormonal therapies L02 in the ATC classificationDRUG

Hormonal therapies L02 in the ATC classification

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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: \-

Locations (1)

Centre Régional de Pharmaco-vigilance - Paris, Pitié-Salpétrière

Paris, Île-de-France Region, France

Outcomes

Primary Outcomes

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