Cohort study of cardiovascular events in patients with chronic obstructive pulmonary disease initiating olodaterol or other long-acting beta2-agonists

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Striverdi Respimat; Stiolto Respimat
• Anatomical Therapeutic Chemical (ATC) code:
  (R03AC12) salmeterol

  salmeterol

  (R03AC13) formoterol

  formoterol

  (R03AC18) indacaterol

  indacaterol

  (R03AC19) olodaterol

  olodaterol

  (R03AK06) salmeterol and fluticasone

  salmeterol and fluticasone

  (R03AK08) formoterol and beclometasone

  formoterol and beclometasone

  (R03AK12) salmeterol and budesonide

  salmeterol and budesonide

  (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
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  The study focused on chronic obstructive pulmonary disease (COPD) patients aged 40 or older in Denmark, a country where olodaterol is available in a fixed combination with tiotropium. The study population included new users of olodaterol or other LABA, with no dispensing of any LABA within 6 months before the first prescription during the study period and at least 1 year of enrolment in the electronic database.; ; Eligibility criteria for patients in both exposure cohort:; • Have been diagnosed with COPD; • Be aged 40 years or older (to minimise the likelihood of including individuals who have asthma only); • Be a new user of olodaterol or a new user of indacaterol, salmeterol, or formoterol (not in fixed-dose combination with an inhaled corticosteroid) and have no dispensing of any LABA in the 6 months before the index date; • Have at least 1 year of enrolment in the electronic database before their first LABA dispensing (defined as the index LABA); • Have data on sex (i.e., sex must be known).
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with chronic obstructive pulmonary disease
• Estimated number of subjects:
  150000

Study design details

• Main study objective:
  To examine the risk of selected cardiac arrhythmias, acute myocardial infarction, and other serious ischemic heart disease events, including unstable angina, in patients with COPD exposed to olodaterol compared with the risk in patients exposed to other LABAs.
• Outcomes:
  Incidence of the following: atrial fibrillation or flutter during new use, hospitalisation for ventricular tachycardia, including ventricular fibrillation/flutter and cardiac arrest, supraventricular tachycardia (other than atrial fibrillation/flutter), hospitalisation for acute myocardial infarction, hospitalisation for serious acute coronary heart disease, including unstable angina, Mortality from all causes.
• Data analysis plan:
  The incidence rate ratio (IRR) and incidence rate difference (IRD) for each event of interest in the olodaterol-exposed group relative to that in the comparator group will be derived. The effects of demographics and specified baseline characteristics will be assessed, and adjusted IRR will be calculated by adjusting for each covariate one at a time. A fitted propensity score model will be used to estimate a propensity score for each patient, and the IRRs for each event of interest will be stratified by propensity score deciles. For each endpoint, IRR and IRD will be stratified by propensity score deciles, and the overall adjusted IRR and IRD and associated 95% confidence intervals will be derived by weighting each stratum by the prevalence among the olodaterol cohort.

Documents

Study results

1222-0054_Synopsis_Redacted

Study publications

Rebordosa C, Farkas DK, Montonen J, Laugesen K, Voss F, Aguado J, Bothner U, Ro…