Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Case/Non-case study
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N03AX09) lamotrigine
lamotrigine

Medical condition to be studied

Arrhythmia supraventricular
Conduction disorder
Ventricular arrhythmia
Cardiac arrest
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

7000
Study design details

Main study objective

The aim of this study is to compare the risks of arrhythmias with lamotrigine compared with other anti-epileptics.

Outcomes

Risk of declaring an arrhythmia

Data analysis plan

The data will be extracted from VigiBase(R). Using a case/non-case design, we will perform univariate logistic regression to estimate the odds ratios (RORs) with their 95% confidence intervals (CI). Reporting odds ratios (RORs) are the odds of exposure among reported cases of arrhythmias relative to the odds of exposure among reported non-cases. Sensitivity analyzes will be performed: First, restrict the analyzes to the reports of physicians. Second, carry out temporal analyzes every 5 years from 1994. Third, carry out analyzes just before the publication of the FDA alert on March 3, 2021.Fourth, analyzes will be performed separately on the four MedDRA high-level terms (HLTs) mentioned in the “case and non-case definitions” section. Fifth, the serious criteria will be analyzed compared to the non-serious ones. Finally, analyzes will be carried out by stratifying the data according to age (18 to 44, 45 to 64, 65 to 74 and over 75) or sex (male or female).