Benzodiazepine and anticholinergic use and incident dementia (ABCD study)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Case-control

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

  (N04A) ANTICHOLINERGIC AGENTS

  ANTICHOLINERGIC AGENTS
• Medical condition to be studied:
  Dementia

Population studied

• Age groups:
  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  326000

Study design details

• Main study objective:
  1. To determine whether the use of benzodiazepines, non-benzodiazepine derivatives or medications with anticholinergic activity increases the risk of dementia, and whether risk increases with increased duration, dosage or concurrent use.2. To determine whether these effects persist beyond medication cessation.
• Outcomes:
  Dementia incidence
• Data analysis plan:
  We will assess the association between benzodiazepine exposure, anticholinergic exposure and dementia using conditional logistic regression. Odds ratios (and 95% confidence intervals) will be provided unadjusted and adjusted for exposure to each class of medications with adverse cognitive effects and covariates. The association between dementia and the primary exposure of DDDs will be examined, for (i) benzodiazepines, (ii) Z-drugs, and medications with (iii) possible, (iv) probable and (v) definite anticholinergic activity. The model will adjust for the covariates as well as the number of DDDs of the other medications with potential adverse cognitive effects.The association between dementia and the following secondary exposures will be separately examined:• Duration of prescriptions. • Any prescription. • For anticholinergics - average ACB sum and duration taking 3 or more possible anticholinergics concurrently.

Documents

Study publications

Richardson K, Fox C, Maidment I, et al. Anticholinergic drugs and risk of demen…