Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N06AA) Non-selective monoamine reuptake inhibitors
Non-selective monoamine reuptake inhibitors
(N06AB) Selective serotonin reuptake inhibitors
Selective serotonin reuptake inhibitors
(N06AX) Other antidepressants
Other antidepressants
(N06CA) Antidepressants in combination with psycholeptics
Antidepressants in combination with psycholeptics

Medical condition to be studied

Death
Haemorrhagic stroke
Ischaemic stroke
Cerebellar stroke
Hospitalisation
Population studied

Age groups

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

Estimated number of subjects

417685
Study design details

Main study objective

Drug U: To describe the incident use of antidepressant drugs in a population ≥65 years old during the period of 2009-2015.Risk A: To compare time to occurrence of the composite outcome variable: first episode of nonfatal stroke, fatal stroke, hospitalization due to stroke, or death from any cause among elderly new users and nonusers of SSRI antidepressant drugs

Outcomes

Risk A: Composite variable of fatal or nonfatal stroke, hospitalization due to stroke, or death from any cause, Risk A: Every single event of the composite outcome

Data analysis plan

Drug U: Demographic, diagnostic and pharmacoepidemiologic data will be analysed using descriptive statistics. Prevalence of antidepressant use will be described for all the study period (2009-2015), and for each year stratified by age group, sex, and indication of prescription. Variables will be reported as mean ± standard deviation, median or as frequency and percentage, as appropriate.Risk A: The cohorts will be formed by matching on the propensity score (PS) of their baseline characteristics. PS will be calculated by logistic regression of antidepressant use. Crude incidence rates, rate ratios and adjusted incidence rates and rate ratios will be reported for the composite outcome. For reporting adjusted incidence rates, calculated by Poisson regression will be used. The hazard ratio for the risk of composite outcome will be calculated. An analysis of marginal structural models for co-morbidity and other confounding variables, whose exposure varies over time, will be applied.