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 identification

• EU PAS number:
  EUPAS47042
• Study ID:
  47043
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  ARBs and ACE inhibitors are the most commonly prescribed antihypertensive drugs among adults in the world. They are first-line drugs for hypertension, heart failure and myocardial infarction. While large clinical trials and meta-analysis post marketing authorization showed no association between antihypertensive and fall, several observational studies on large cohorts of real-life patients have shown the opposite. Although these studies have assessed the risk of fall and trauma associated with RAS as a class, whether differences exist between ARBs and ACE inhibitors is unclear. Indeed, ARBs and ACE inhibitors have different pharmacodynamic mechanisms, which may in turn induce different antihypertensive effects. The primary mechanism of action of ARBs is to reduce AT1 receptor activation, even more effectively than ACE inhibitors. ARBs also promote higher activation of AT2 receptors, which enhances their antihypertensive action. 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 a multivariable Cox proportional-hazards outcome models using
• Study status:
  Ongoing

Research institutions and networks

Institutions

University Hospital Purpan

Pharmacologie En Population cohorteS et biobanqueS

Study timelines

Date when funding contract was signed

Planned:31/01/2022

Actual:31/01/2022

Study start date

Planned:14/02/2022

Actual:28/02/2022

Data analysis start date

Planned:04/04/2022

Actual:18/04/2022

Date of final study report

Planned:01/07/2022

Sources of funding

EU institutional research programme

More details on funding

CHU Martinique

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only