DARWIN EU® - Sex differences in treatment patterns for primary hypertension in European countries

Study type

• Study topic:
  Human medicinal product
• 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

• Medicinal product name, other:
  Antihypertensive drugs (ATC classes: C02, C03, C07, C08, C09)
• Anatomical Therapeutic Chemical (ATC) code:
  (C02) ANTIHYPERTENSIVES

  ANTIHYPERTENSIVES

  (C03) DIURETICS

  DIURETICS

  (C07) BETA BLOCKING AGENTS

  BETA BLOCKING AGENTS

  (C08) CALCIUM CHANNEL BLOCKERS

  CALCIUM CHANNEL BLOCKERS

  (C09) AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

  AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Population studied

• Short description of the study population:
  Objective 1 (Characterisation of antihypertensive drug treatment initiation); Inclusion criterion: First ever diagnosis of primary hypertension during the recruitment period; Exclusion criteria; • Age <18 years at first diagnosis of primary hypertension (index date); • Less than 365 days of available history before the index date; • Record of primary hypertension before index date; • Record of secondary hypertension on or before the index date; • Record of antihypertensive drug prescription/dispensation before the index date; Objectives 2 and 3 (Drug utilisation of treatment and characterisation of treatment switching patterns); Inclusion criteria; • First ever diagnosis of primary hypertension during the recruitment period; • Initiation of antihypertensive drug treatment within 180 days after diagnosis (index date); Exclusion criteria; • Age <18 years on the date of antihypertensive drug treatment initiation; • Less than 365 days of available history before the date of antihypertensive drug treatment initiation ; • Record of primary hypertension before index date; • Record of secondary hypertension on the day of or before diagnosis of primary hypertension; • Record of antihypertensive drug prescription/dispensation before the first diagnosis of primary hypertension;
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • 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 data sources from 5 countries across Europe
• Main study objective:
  1. To describe antihypertensive treatment initiation for primary hypertension in males and females ; 2. To describe drug utilisation of antihypertensive treatments, including initial treatment duration and initial dose, in males and females; 3. To describe antihypertensive treatment switching patterns in males and females ;