Multinational database cohort study to assess RMP specified safety outcomes in association with indacaterol/glycopyrronium bromide in Europe

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  INDACATEROL

  GLYCOPYRRONIUM BROMIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (R03AL04) indacaterol and glycopyrronium bromide

  indacaterol and glycopyrronium bromide
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  Population of patients ≥40 years of age with at least one year of valid database history and a recorded diagnosis of COPD. Valid database history means that there is at least one year of database history for a patient. This means that the patient was registered with the GP since at least one year but also that the GP is providing data to the database for at least one year as well. For all patients an eligibility date will first be defined, which is the latest of the following dates: reaching 40 years of age, having one year of data in the database and having fulfilled the criteria for a diagnosis of COPD. Diagnoses of COPD may be searched in the entire available prior history of a patient.
• 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:
  Chronic obstructive pulmonary disease (COPD) patients
• Estimated number of subjects:
  6000

Study design details

• Main study objective:
  To assess the incidence rates and relative risks of selected endpoints in association with QVA149 exposure in a broader, real-world COPD population.
• Outcomes:
  Primary endpoints of interest are 1) Major cardiovascular events (myocardial infarction (MI) stroke, hospitalizations due to acute coronary syndrome orheart failure), 2) Ischemic heart disease including MI and angina pectoris, 3) cerebrovascular events (ischemic stroke, hemorrhagic stroke and (TIA)), 4) Cardiac arrhythmias (atrial fibrillation/flutter and ventricular arrhythmia, The secondary endpoints of interest are 1) (Narrow-angle) Glaucoma, 2) Bladderobstruction/urinary retention/incident BPH, 3) Diabetes Mellitus, 4) Bronchospasmand 5) all-cause mortality
• Data analysis plan:
  Cox regression will be used to estimate both crude and adjusted relative risks (expressed as hazard ratios HRs with 95% CIs), allowing for time-varying exposures.All analyses will be performed for each database separately. Effect estimates will be pooled across the databases, using a random effects approach. In addition, a pooled mega-analysis will be done by combining the data sources on a patient-level and adjusting for the database.As secondary analysis, subsequent episodes, with or without treatment, will be taken into account. The anchor drug will be used as reference category, HRs of the events will be estimated for all other treatment categories compared to this reference. In addition, a sensitivity analysis will be conducted only considering the first treatment episode during follow-up in patients naïve to both QVA149 and all comparator drugs.Specific patient groups will be studied via stratified analysis on age, gender,underlying CV co-morbidity and COPD severi

Documents

Study results

qva149a2402--legacy-clinical-study-report-redacted_Part1

Study report

qva149a2402--legacy-clinical-study-report-redacted_Part2