Study type

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Drug utilisation
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Hypertension
Depression
Population studied

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

15000
Study design details

Main study objective

Our primary objective is to estimate the prevalence, incidence, and clearance (incidence of antidepressant drugs withdrawal) of antidepressant drugs prescription in hypertensive patients under treatment with angiotensin agents (ARBs and/or ACEIs).

Outcomes

Primary Outcome Measures: • Number of patients under treatment with antihypertensive drugs and with antidepressant drugs • Number of patients under treatment with antihypertensive drugs, Secondary Outcome Measures: 1. Number of patients diagnosed with Hypertension 2. Number of patients diagnosed with Depression 3. Number of patients treated with ARBs 4. Number of patients treated with ACEIs 5. Number of patients treated with other antihypertensive drugs 6. Number of patients treated with Amitriptyline 7. Number of patients treated with Duloxetin

Data analysis plan

A general descriptive analysis of all study variables will be provided. The results will be expressed as means and standard deviation, the median (maximum and minimum values) for the quantitative variables, and the absolute and relative frequencies of each category, for the categorical variables. The prevalence and incidence and their 95% confidence intervals will be estimated. The ‘time until beginning’ and the ‘time until withdrawal’ of an antidepressant drug will be calculated. An exploratory analysis by gender will be carried out. The software used to perform the statistical analysis will be R version 3.6 or higher.