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
Disease epidemiology
Drug utilisation

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

ETORICOXIB

Anatomical Therapeutic Chemical (ATC) code

(M01AH05) etoricoxib
etoricoxib

Medical condition to be studied

Ankylosing spondylitis
Spondyloarthropathy
Population studied

Short description of the study population

A patient was eligible for inclusion on the first date who have met all of the following criteria:
- Attended an out-patient clinic 2001-2010
- Age >=16 years on the date attended the out-patient clinic
- Registered with an ICD-code corresponding to SPA/AS (i.e. ICD10: M46.1, M46.8, M46.9, and ICD9: 720B, 720C or 720X for the appropriate periods) and AS (i.e. ICD10: M459 and ICD9: 720A for the appropriate periods)

Age groups

  • Paediatric Population (< 18 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)

Special population of interest

Other

Special population of interest, other

Ankylosing spondylitis and Spondyloarthropathy patients

Estimated number of subjects

21108
Study design details

Main study objective

Describe characteristics of Swedish participants with inflammatory SpA/AS, describe use of etoricoxib & other COX-2 inhibitors/nsNSAIDs in Swedish participants with SpA/AS, estimate & compare rates of clinical outcomes of special interest (GI, renovascular, CV, cerebrovascular) with use of etoricoxib & other COX-2 inhibitors/nsNSAIDs in Swedish participants with SpA/AS.

Outcomes

Number of participants with characteristics of inflammatory SpA/AS, participants who used etoricoxib, participants who used other COX-2 inhibitors, participants who used nsNSAIDs, clinical outcomes of special interest. Outcomes included atherosclerotic CV events, atherosclerotic cerebrovascular events, congestive heart failure, severe hypertension, renovascular, and GI events.

Data analysis plan

Comparisons of clinical outcomes among the drugs of interest will be made by descriptive comparison of the point estimates for the incidence rates and their associated 95% confidence intervals (CIs), using both clinical and epidemiological judgment and in light of the limitations of this observational study. No formal statistical significance testing will be performed for purposes of such comparisons.