Clinical trial NCT03259711: Comparison of Cardiotoxicity Induced by Selective Estrogen REceptor Modulators and aNti-Aromatase
Official title: Cardiotoxicity of Selective Estrogen Receptor Modulators and Aromatase Inhibitors in the European Pharmacovigilance Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Affections
Keywords: Cardiotoxicity
selective estrogen receptor modulators
aromatase inhibitors
hormone replacement therapy
estrogen
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is selected in the Eurodravigilance database from 01/2002 to 08/2017 and included patients treated with hormonal therapies L02 in the ATC classification.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: 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
timeFrame: Immediate evaluation
Secondary outcomes:
measure: 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)
timeFrame: Immediate evaluation
measure: Disproportionality analysis of the reporting of drug-induced ventricular arrhythmia's with selective estrogen receptor modulators as compared to aromatase inhibitors
timeFrame: Immediate evaluation
measure: Disproportionality analysis of the reporting of drug- induced QT prolongation with selective estrogen receptor modulators as compared to aromatase inhibitors
timeFrame: Immediate evaluation
measure: Disproportionality analysis of the reporting of drug-induced Torsade de Pointe with selective estrogen receptor modulators as compared to aromatase inhibitors
timeFrame: Immediate evaluation
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Régional de Pharmaco-vigilance - Paris, Pitié-Salpétrière
state: Ile De France
Study officials:
affiliation: Centre Régional de Pharmaco-vigilance - Paris, Pitié-Salpétrière
name: Joe-Elie Salem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grouthier V, Lebrun-Vignes B, Glazer AM, Touraine P, Funck-Brentano C, Pariente A, Courtillot C, Bachelot A, Roden DM, Moslehi JJ, Salem JE. Increased long QT and torsade de pointes reporting on tamoxifen compared with aromatase inhibitors. Heart. 2018 Nov;104(22):1859-1863. doi: 10.1136/heartjnl-2017-312934. Epub 2018 May 2.