A Pharmacovigilance Study of Torsade de Pointes

A Pharmacovigilance Study of Torsade de Pointes in the Food and Drug Administration Adverse Event Reporting System Using Data Mining Algorithms

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.

Study Overview

• Status: Completed
• Conditions: Torsades de Pointe Caused by Drug
• Intervention / Treatment: Drug: Drugs, Generic

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.

• Study Type: Observational
• Enrollment (Actual): 6670

Contacts and Locations

Study Locations

• Pakistan
  • Khyber Pakhtunkhwa
    • Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
      • Department of Pharmacy, University of Peshawar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presented with TdP treated for any disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group/Cohort; Torsade de Pointes induced by drugs reported to the FAERS database from inception till first quarter of 2019 (1990-2019)	Drug: Drugs, Generic; All drugs having ≥10 TdP cases reported in the FAERS database

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of drugs associated with TdP	The search includes MedDRA (v-22) Preferred Term, "Torsade de Pointes (MedDRA code: 10044066) for the identification of all TdP case reports and drugs.	Cases reported to the FAERS database till 31/03/2019
Identification of new signals of TdP	Signal detection using disproportionality analysis	Cases reported to the FAERS database till 31/03/2019

Secondary Outcome Measures

Outcome Measure	Time Frame
Validation of already known drug-TdP associations	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
Stratification of new signals with respect to gender	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
Description of the population of patients having TdP	Cases reported to the FAERS database till 31/03/2019

Collaborators and Investigators

• Sponsor: University of Peshawar

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2019
• Primary Completion (ACTUAL): December 22, 2019
• Study Completion (ACTUAL): January 1, 2020

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (ACTUAL): March 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2020
• Last Update Submitted That Met QC Criteria: February 28, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia, Ventricular; Tachycardia; Torsades de Pointes
• Other Study ID Numbers: PV-TdP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes