Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Case-crossover
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N05BA) Benzodiazepine derivatives
Benzodiazepine derivatives
(N05CD) Benzodiazepine derivatives
Benzodiazepine derivatives
(N05CF) Benzodiazepine related drugs
Benzodiazepine related drugs

Medical condition to be studied

Suicide attempt
Completed suicide
Population studied

Short description of the study population

Patients ≥16 years , with hospitalised suicide attempt or suicide between 2013 and 2016, and at least one benzodiazepine dispensing within the 120 days before their act.

Age groups

Adults (18 to < 46 years)

Estimated number of subjects

70000
Study design details

Main study objective

This study aimed at estimating the risk of suicide attempt and suicide death associated with recent exposure to benzodiazepines in patients with or without recent psychiatric history using methods minimizing confounding factors.

Outcomes

Suicide attempts as hospitalisation with hospital discharge codes for intentional self-harm. Suicide deaths identified through the causes-of-death registry as those with intentional self-harm codes as well.

Data analysis plan

The suicidal outcomes were hospitalised suicide attempts and suicide, identified through the hospital discharge and causes-of-death registry, using ICD-10 codes X60-X84. Patients were considered exposed to benzodiazepines within one of the studied periods of interest (risk/reference) if they have been reimbursed for at least one dispensing of a benzodiazepine during this period. Conditional logistic regression models were used to estimate the crude and adjusted odds ratios (OR) of suicidal behaviours associated with benzodiazepine over the risk period compared with the reference periods. Models were adjusted for time-varying confounders (other psychotropics). Sensitivity analyses concerned: varying lengths of risk and reference periods, performing another CCO analysis using cyamemazine as a negative control with similar risk of indication bias, performing a case-case-time-control model to examine whether the main CCO analysis was confounded by a time trend in benzodiazepine use.