DARWIN EU® - DUS Characterising STOPP criteria medication use in people with recurrent falls

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

No information provided.

Population studied

• Short description of the study population:
  The study cohort will include individuals aged 65 years and older diagnosed with recurrent falls registered in the respective databases between 1st of January 2013 and 31st December 2023, with at least 1 year of data visibility prior to the date of recurrent falls diagnosis. Recurrent falls will be defined as 2 or more falls within a period of 12 months. ; Additional eligibility criteria will be applied for survival analysis: a minimum of 1 year of potential follow-up after index date, will be applied for survival analysis.
• Age groups:
  • Elderly (≥ 65 years)

    • Adults (65 to < 75 years)
    • Adults (75 to < 85 years)
    • Adults (85 years and over)

Study design details

• Study design:
  A cohort study will be conducted using routinely collected health data from 5 databases.
• Main study objective:
  Research question: What are the characteristics of patients with recurrent falls and how are STOPP Section K criteria medicines prescribed in Europe?; ; Study objectives:; 1. To characterise individuals aged 65 years and older with recurrent falls in terms of age, gender, risk factors, comorbidities and concomitant prescriptions. Results will be stratified by database and where feasible by healthcare setting.; 2. To estimate the overall survival of individuals aged 65 and older with recurrent falls. ; 3. To estimate prevalence of use of drug classes belonging to the STOPP section K criteria in individuals aged 65 and older, categorised into two cohorts: those with recurrent falls and those without recurrent falls. Results will be stratified by database, calendar year, age and sex. ; 4. To estimate incidence of use of drug classes belonging to the STOPP section K criteria in individuals aged 65 year and older, categorised into two cohorts: those with recurrent falls and those without recurrent falls. Results will be stratified by database, calendar year, age and sex. ; 5. To characterise a cohort of individuals aged 65 years and older with recurrent falls at time of their new prescription of any of the drug classes belonging to the STOPP section K criteria in terms of age, sex, comorbidities and comedication. Additionally, the proportion of individual drug substances within each drug class belonging to the STOPP section K criteria will be provided. Results will be stratified by database.; 6. To determine the median duration of use the different drug classes belonging to the STOPP section K criteria at time of treatment initiation of drugs of interest in the individuals aged 65 and older, categorised into two cohorts: those with recurrent falls and those without recurrent falls. To provide product names with details on strength, formulation and volume.
• Setting:
  Outpatient setting using data from the following 5 data sources: CPRD GOLD (UK), IQVIAL DA Germany (Germany), FinOMOP – HILMO (Finland), NAJS (Croatia) and SIDIAP (Spain).
• Outcomes:
  The main outcome of the study was death. Overall survival in patients with incident recurrent falls was calculated based on the registered date of death. Individuals contributed their survival time as per follow up described in section 8.4.
• Summary results:
  [CONCLUSION]; In this study, we characterised 271,338 individuals aged 65 years and older newly diagnosed with recurrent ; falls between 2013 and 2023, utilising data from multiple European sources. Older adults with recurrent falls frequently presented with comorbid conditions, with many presenting conditions likely to be a consequence of the fall, such as injuries and fractures. This underscores the significant public health challenge posed by recurrent falls in the elderly population. ; Our analysis demonstrated that STOPP section K criteria drug classes were prescribed at similar or even greater prevalence and incidence rates in individuals aged 65 years and older following a new diagnosis of recurrent falls compared to those without recurrent falls. The most commonly prescribed drug classes included vasodilating drugs, opioids, antidepressants and benzodiazepines, with variation in prevalence and incidence rates across the cohorts. ; These findings highlight the importance of identifying older adults with recurrent falls as a population at increased risk. This population may benefit from medication review. A comprehensive approach to medication management, with careful assessment of fall risk, may improve patient safety and reduce consequences of falls and related complications.