Burden and consequences of the use of COPD-related systemic corticosteroids (OCS COPD study)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (H02) CORTICOSTEROIDS FOR SYSTEMIC USE

  CORTICOSTEROIDS FOR SYSTEMIC USE
• 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:
  193320

Study design details

• Main study objective:
  To evaluate patterns of use, risk of comorbidities associated with COPD-related systemic corticosteroids use, and related cost impact on COPD patients in the CPRD database
• Outcomes:
  We aim to: 1.Describe patterns of COPD-related SCS use 2.Measure the association between COPD-related SCS exposure and (1) the incidence of outcome morbidities (2) the worsening or recurrence of outcome morbidities 3.Quantify annualised and longitudinal healthcare resource utilisation and associated costs to the healthcare system due to SCS-related all-cause and specified comorbid conditions, To describe: 1.patterns of all-cause SCS 2.longitudinal SCS exposure pre- and post diagnosis of COPD 3.cumulative OCS dose per moderate COPD exacerbation 4.patients who are not on maintenance therapy pre- and post COPD diagnosis 5.changes in maintenance therapy by SCS 6.correlation of SCS with changes in blood eosinophil counts 7.potential SCS dose thresholds at which comorbidities occurs
• Data analysis plan:
  For each SCS-related condition, a multivariable Cox proportional hazard model will be considered with time-depending or -varying exposure measures and confounders accounted for at baseline. Each analysis will be adjusted for the variables identified as residual confounders during the baseline analysis. Time to event will be defined as the time from index date up to the onset of SCS-related conditions. The HCRU outcomes and associated costs to the healthcare system will be described for each of the resource components and SCS-related all-cause and specified comorbid conditions for all complete years of follow-up from the index date until the end of the last completed follow-up year, separately for each risk cohort. Generalised estimating equations with cluster robust standard errors, log link and gamma distribution will be used to estimate the effect of different strata of SCS exposure on annualised HCRU or costs.