Association between anxiolytic or hypnotic drugs and total mortality

Study type

• Study topic:
  Human medicinal product
• 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:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (M03BX07) tetrazepam

  tetrazepam

  (N03AE01) clonazepam

  clonazepam

  (N05BA) Benzodiazepine derivatives

  Benzodiazepine derivatives

  (N05CD) Benzodiazepine derivatives

  Benzodiazepine derivatives

  (N05CF) Benzodiazepine related drugs

  Benzodiazepine related drugs

Population studied

• Short description of the study population:
  The French and the UK adult population, including both genders.; Patients aged 18 and more, patients with First Registration Date or Current Registration Date > 12 months, acceptable Patient Flag (patients records meeting sufficient quality standard for research) (for CPRD), patients whose practice consented for linkage scheme (ONS mortality data available) (for CPRD) were included.
• 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:
  120000

Study design details

• Main study objective:
  The aim of this project will be to investigate mortality associated with benzodiazepine derivatives or related substances exposure in France and in the UK.
• Outcomes:
  All-cause mortality, Cause-specific mortality
• Data analysis plan:
  The role of potential confounding or explanatory variables will be taken into account by the extended Cox regression model. A univariate analysis will be first performed to select the variables with a p value<0.2, followed by a multivariate approach using the Cox proportional hazard regression model with time dependent covariates, with stratification on the matched pairs. Continuous variables will be tested for linearity. Relevant interactions between covariates will be checked. Proportional hazards assumption will be tested for all covariates. The estimation of the crude and adjusted Hazard Ratio and their 95% confidence interval will be provided.