Torsades de Pointe Caused by Drug
Conditions
Brief summary
Many cardiac and non-cardiac drugs are associated with TdP that may constitute a significant problem because of sudden cardiac death. This study aims to present a comprehensive overview and disproportionality analysis of TdP cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) in order to identify new signals of TdP.
Detailed description
Drug-induced Torsade de Pointes (TdP) is a serious but an overlooked adverse drug reaction because a wide range of marketed drugs associated with TdP are commonly prescribed in routine practice. Owing to the heightened concern of a vast number of drug-TdP associations including newly approved drugs, the investigators, therefore, aims to investigate drug-TdP associations by performing disproportionality analysis in order to identify new signals of TdP utilizing the individual case reports of TdP in the FAERS database.
Interventions
DRUGDrugs, Generic
All drugs having ≥10 TdP cases reported in the FAERS database
Sponsors
University of Peshawar
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* TdP cases reported in the FAERS database till 31/03/2019 * Adverse event reported was including the MedDRA term: Torsade de Pointes
Exclusion criteria
* Drugs with less than 10 TdP reports
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of drugs associated with TdP | Cases reported to the FAERS database till 31/03/2019 | The search includes MedDRA (v-22) Preferred Term, Torsade de Pointes (MedDRA code: 10044066) for the identification of all TdP case reports and drugs. |
| Identification of new signals of TdP | Cases reported to the FAERS database till 31/03/2019 | Signal detection using disproportionality analysis |
Secondary
| Measure | Time frame |
|---|---|
| Stratification of new signals with respect to gender | Cases reported to the FAERS database till 31/03/2019 |
| Validation of already known drug-TdP associations | Cases reported to the FAERS database till 31/03/2019 |
| Description of the population of patients having TdP | Cases reported to the FAERS database till 31/03/2019 |
| Trends of TdP reports in FAERS database | Cases reported to the FAERS database till 31/03/2019 |
| Stratification of new signals with respect to age | Cases reported to the FAERS database till 31/03/2019 |
Countries
Pakistan
Outcome results
None listed