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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-01-31

Study Completion Date

2017-08-14

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.

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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.

Conditions

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Cardiac Affections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Hormonal therapies L02 in the ATC classification

Intervention Type DRUG

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