Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Name of medicine:
  BRETARIS

  BRETARIS GENUAIR 400 µG - INHALATION POWDER, PRE-DISPENSED

  BRIMICA

  BRIMICA GENUAIR 340 µG + 12 µG - INHALATION POWDER

  DUAKLIR

  DUAKLIR GENUAIR 340 µG + 12 µG - INHALATION POWDER

  EKLIRA

  EKLIRA GENUAIR 322 µG - INHALATION POWDER, PRE-DISPENSED
• Study drug International non-proprietary name (INN) or common name:
  ACLIDINIUM BROMIDE

  FORMOTEROL FUMARATE DIHYDRATE
• Anatomical Therapeutic Chemical (ATC) code:
  (R03AC12) salmeterol

  salmeterol

  (R03AC13) formoterol

  formoterol

  (R03AC18) indacaterol

  indacaterol

  (R03AC19) olodaterol

  olodaterol

  (R03AK06) salmeterol and fluticasone

  salmeterol and fluticasone

  (R03AK07) formoterol and budesonide

  formoterol and budesonide

  (R03AL03) vilanterol and umeclidinium bromide

  vilanterol and umeclidinium bromide

  (R03AL04) indacaterol and glycopyrronium bromide

  indacaterol and glycopyrronium bromide

  (R03AL05) formoterol and aclidinium bromide

  formoterol and aclidinium bromide

  (R03AL06) olodaterol and tiotropium bromide

  olodaterol and tiotropium bromide

  (R03AL07) formoterol and glycopyrronium bromide

  formoterol and glycopyrronium bromide

  (R03BB04) tiotropium bromide

  tiotropium bromide

  (R03BB05) aclidinium bromide

  aclidinium bromide

  (R03BB06) glycopyrronium bromide

  glycopyrronium bromide

  (R03BB07) umeclidinium bromide

  umeclidinium bromide
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

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:
  105000

Study design details

• Main study objective:
  To compare the risk of all-cause mortality, congestive heart failure, acute myocardial infarction, stroke, and cardiac arrhythmias in patients with COPD initiating treatment with aclidinium bromide with the risk in patients with COPD initiating other treatments for COPD.
• Outcomes:
  All-cause mortality, congestive heart failure, acute myocardial infarction, stroke, and cardiac arrhythmias.
• Data analysis plan:
  A descriptive analysis of the study cohorts will be performed. Crude and age and sex- standardized incidence rates will be estimated for each study cohort. ; A cohort analysis will be performed to estimate crude and adjusted relative risks (RRs) and 95% CIs for each study endpoint using conditional multiple logistic regression to compare:; --Current, recent, and past use of aclidinium and of each study medication with current use of LABAs; --Current single use of aclidinium and of each study medication with current single use of LABAs; --Current single use of aclidinium with current single use of each study medication. Analyses will also be performed stratified by specific subgroups of patients (e.g. by COPD severity, age groups, or history of cardiovascular disease) among current users of the study medications. ; The effect of dose and duration of use will be estimated among current single users of each study medication.

Documents

Study results

4368_Abstract_Final results - Redacted.pdf

4669_Abstract_Final results__Redacted.pdf

5405_Abstract_Final results__Redacted.pdf

6182_Abstract_Final results__Redacted.pdf

Study publications

A Cohort Study to Evaluate the Risk of Hospitalisation for Congestive Heart Fai…

Are you really dead? Validation of death and date of death in patients with COP…

Hospitalization for heart failure among patients using aclidinium bromide and o…

Use of aclidinium did not increase the risk of death in a noninterventional coh…

A validation exercise: identifying hospitalizations for heart failure among pat…

Risk Assessment of Acute Myocardial Infarction and Stroke Associated with Long-…

Acute myocardial infarction, stroke, and MACE in COPD patients treated with acl…