An observational historical cohort study to evaluate chronic disease onset associated with long-term oral corticosteroid and it’s cost impact on patients in the OPCRD / CPRD databases

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

  Other
• Non-interventional study design, other:
  Historical cohort database study

Study drug and medical condition

• Medical condition to be studied:
  Type 2 diabetes mellitus

  Hypertension

  Osteoporosis

  Sleep disorder

  Sleep apnoea syndrome

  Pneumonia

  Glaucoma

  Cataract

  Depression

  Anxiety

Population studied

• Short description of the study population:
  Patients in OPCRD / CPRD databases prescribed with long-term oral corticosteroid
• 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:
  108217

Study design details

• Main study objective:
  To establish the association between long term (total dose, total duration and average total daily dose and current measures (current dose and current use) of OCS exposure and incidence of related conditions such as type 2 diabetes mellitus, osteoporosis/ osteoporotic fractures, hypertension, glaucoma, sleep apnoea, weight gain and depression/anxiety.
• Outcomes:
  type 2 diabetes, osteoporosis/osteoporotic fractures, hypertension, glaucoma, sleep apnoea, weight gain and depression/anxiety. pneumonia, cataracts, sleep disorders, cardiovascular disease, chronic kidney disease, dyslipidaemia and peptic ulcer disease.Annualised healthcare resource utilisation and related cost
• Data analysis plan:
  Different time-dependent OCS exposure measures will be explored, defined as current use (yes/no), current dose (mg/day), total dose (g), total duration of exposure (months) and average total daily dose (mg/day). For each corticosteroid related condition, multivariable Cox proportional hazard models will be fitted separately for each of the five time-dependent OCS exposure measures. To determine critical OCS dose thresholds, total dose and daily dose will be categorised into relevant levels and the risk of developing the outcome of interest will be compared between each category of corticosteroid treatment arm and control arm.