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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hormonal therapies L02 in the ATC classification | Drug | Hormonal therapies L02 in the ATC classification |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Joe-Elie Salem, MD, PhD | Centre Régional de Pharmaco-vigilance - Paris, Pitié-Salpétrière | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Régional de Pharmaco-vigilance - Paris, Pitié-Salpétrière | Paris | Île-de-France Region | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29720397 | Result | 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. |
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| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |