Post-authorization safety Electronic Medical Records database retrospective cohort study of new users of inhaled UMEC/VI or new users of inhaled UMEC in the primary care setting

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

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective longitudinal non-interventional observational study

Study drug and medical condition

• Name of medicine:
  ANORO ELLIPTA

  INCRUSE ELLIPTA

  LAVENTAIR ELLIPTA
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  The main study population consisted of new users of UMEC/VI, UMEC or Other LABD with ‘acceptable’ data quality in the CPRD-GOLD and THIN databases. Patients were labelled as ‘acceptable’ if they had continuous follow up and did not meet criteria for poor data recording.; Inclusion criteria:; 1. A record for a new prescription of UMEC/VI, UMEC, or Other LABD between July 1, 2014 and June 30, 2016 (inclusive).; 2. At least 12 months of registration at a practice with ‘up to standard data’ recording prior to index prescription date to allow characterization of patient’s status, demographics and clinical characteristics. Data were considered ‘up to standard’ when the GP practice had continuous high-quality data fit for use in research.; Exclusion criteria:; 1. A prescription for the same specific inclusion medication (or combination) of LABD ever recorded in the past. Prior or concomitant use of respiratory medications containing a different specific active substance (or combination) than the new substance initiated was allowed.
• Age groups:
  • Paediatric Population (< 18 years)

    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  2000

Study design details

• Main study objective:
  This study primarily aims to collect data reflecting the ‘real-world’ experience with umeclidinium/vilanterol (UMEC/VI) and umeclidinium (UMEC) in the post-approval setting. UMEC/VI and UMEC as well as other medications containing only long-acting bronchodilators (LABD) are indicated for the treatment of Chronic Obstructive Pulmonary Disease (COPD).
• Outcomes:
  Off-label use, defined as prescribing in patients without a recorded diagnosis of COPD. 1. The frequency of Myocardial infarction, Heart failure, Stroke, Pneumonia, Death, COPD exacerbations 2. Treatment patterns (discontinuation, switch or augmentation) and medication adherence (Medication Possession Ratio (MPR) and Proportion of Days Covered (PDC)
• Data analysis plan:
  Primary Outcome: Among new users of UMEC/VI, UMEC, or other LABD, calculate the proportion with off label use according to presence or absence of a COPD diagnosis record.Secondary Outcomes: Among new users of UMEC/VI or UMEC, calculate the incidence (new events/person-time) of myocardial infarction, heart failure, stroke, death, pneumonia/lower respiratory tract infections, and exacerbations of COPD.Among new users UMEC/VI or UMEC, describe treatment patterns (discontinuation, switching and augmentation) and adherence to treatment using medication possession ratio proportion of days covered during the 0-12 months of follow-up.