Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Safety study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(R05DA04) codeine
codeine
(N02AA79) codeine, combinations with psycholeptics
codeine, combinations with psycholeptics
(N02AJ06) codeine and paracetamol
codeine and paracetamol
(N02AJ07) codeine and acetylsalicylic acid
codeine and acetylsalicylic acid
(N02AJ08) codeine and ibuprofen
codeine and ibuprofen
(N02AJ09) codeine and other non-opioid analgesics
codeine and other non-opioid analgesics
(N02AJ13) tramadol and paracetamol
tramadol and paracetamol
(N02AJ14) tramadol and dexketoprofen
tramadol and dexketoprofen
(N02AJ15) tramadol and other non-opioid analgesics
tramadol and other non-opioid analgesics
(N02AX02) tramadol
tramadol

Medical condition to be studied

Delirium
Drug abuse
Fear of falling
Drug dependence
Death
Cardiovascular disorder
Cerebrovascular accident
Constipation
Sleep disorder
Multiple fractures
Population studied

Short description of the study population

All subjects registered for at least 1 year in the SIDIAP database during the study period. The source population includes all users of any of the study drugs (tramadol/codeine) during the study period, aged 18 years or older at the time of therapy initiation.

Age groups

  • 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

1186887
Study design details

Main study objective

To assess the incidence of adverse events among incident users of tramadol compared to codeine users among subjects ≥ 18 years old in Catalonia, Spain.

Data analysis plan

Incidence rates (IR), absolute rate difference (RDs), and adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated using cause-specific Cox proportional hazards regression model accounting for competing risk of death. Propensity-score (PS) matching was used to minimize confounding. Missing information: Since the underlying data represent attended medical care, we assume that absence of information of clinical events means absence of that condition. Variables with missingness will treated as categorical with a missing category.