Association of Use of Angiotensin-converting Enzyme Inhibitors and Angiotensin II Receptor Blockers with fall and trauma-related hospitalization among elderly patients: a nationwide population- based 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:
  (C09A) ACE INHIBITORS, PLAIN

  ACE INHIBITORS, PLAIN

  (C09C) ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN

  ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN

Population studied

• Age groups:
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  18097

Study design details

• Main study objective:
  Determine whether use of ARBs, when compared with ACE inhibitors, is associated with an increased risk of fall and trauma-related hospitalization among of 65 years and older
• Outcomes:
  Occurrence of a hospitalization for fall or trauma during the follow-up. - Hospitalization for syncope or malaise during the follow-up. - Hospitalization for orthostatic hypotension during the follow-up. - Onset of death during the follow-up. - Onset of ICU hospitalization during the follow-up.
• Data analysis plan:
  Primary analysis Descriptive analysis / Potential confounders / Incidence rates HRs with 95% CIs of fall and trauma with Cox proportional hazards with PS matching models Secondary analysis Repetition of the primary analysis for the risk of other serious events Sensitivity analysis Subgroup analyses / by varying the outcome / duration of use of drugs