Risk of switching to angiotensin-II receptor blocker therapy in people with asthma who initiate ACE inhibitor therapy compared to the general population: a retrospective cohort study

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  100000095102

  ACE inhibitors, plain

  100000095140

  Angiotensin II receptor blockers (ARBs), plain
• Medical condition to be studied:
  Asthma

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:
  500000

Study design details

• Main study objective:
  To examine whether people with asthma are at a greater risk of ACE inhibitor intolerance by examining whether they are more likely to switch to an angiotensin-II receptor blocker (ARB) after initiation of ACE inhibitor therapy.
• Outcomes:
  Switching to an ARB within 6 months of ACE inhibitor discontinuation
• Data analysis plan:
  Hazard ratios will be calculated using Cox proportional hazards regression for the risk of switching to an ARB after initiation of ACE inhibitor therapy in people with asthma compared to the general population. People with COPD will act as a negative control.