Risk of suicide attempt and suicide associated with benzodiazepine: a nationwide case crossover study (R.SUB)

Study identification

• EU PAS number:
  EUPAS48070
• Study ID:
  48101
• Official title and acronym:
  Risk of suicide attempt and suicide associated with benzodiazepine: a nationwide case crossover study (R.SUB)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  While benzodiazepines are commonly prescribed in patients with suicidal ideation, their impact on the risk of suicidal behaviours is unknown. Previous studies that found a positive association between benzodiazepine exposure and suicidal behaviours were confounded by indication bias. The association between benzodiazepines and suicidal behaviours has to be clarified to inform evidence-based practice guidelines for suicidal risk management. The main objective of the present study is to estimate the risk of suicide attempt and suicide associated with benzodiazepines. This is a case crossover study (CCO) in a national healthcare claims and hospitalisations databases including patients ≥16y, with hospitalised suicide attempt or suicide between 2013 and 2016, and at least one benzodiazepine dispensing within the 120 days before their act (i.e., the observation period). Individuals are separated according to the identification of psychiatric history over the year preceding the observation period. For each patient, frequency of benzodiazepine dispensing is compared between a risk period (days -30 to -1 before the event) and two matched reference periods (days -120 to -91, and -90 to -61). Self-controlled CCO analyses are adjusted for psychotropic drugs use within the observation period. A CCO considering a negative control explores residual indication bias, and a case-case-time-control analysis addresses time-trend bias.
• Study status:
  Finalised

Research institutions and networks

Institutions

Academic Center for Pharmacoepidemiology (DRUGS-SAFEr)

Study timelines

Date when funding contract was signed

Actual:07/11/2019

Study start date

Actual:05/05/2021

Date of final study report

Actual:10/06/2022

Sources of funding

Other

More details on funding

ANSM

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable