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
Drug utilisation
Safety study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Post authorization safety study (PASS)
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N02AJ14) tramadol and dexketoprofen
tramadol and dexketoprofen
(N02AJ13) tramadol and paracetamol
tramadol and paracetamol
(N02AX02) tramadol
tramadol

Medical condition to be studied

Pain
Population studied

Short description of the study population

All patients aged 18 years or older being registered in the databases between January 1, 2017 and December 31, 2018.

Inclusion criteria
Primary objectives (drug utilisation): all patients aged 18 years or older with at least 1-year medical history in the database and prescribed with DKP-TRAM coded via the Anatomical Therapeutic Chemical (ATC) classification system (ATC: N02AJ14) will be identified. For each patient, the date of the first prescription of DKP-TRAM being registered in the study period will be the index date.
Secondary objectives (comparative safety): all patients aged 18 years or older and newly prescribed with DKP-TRAM (ATC: N02AJ14) or tramadol (ATC: N02AX02) or tramadol-paracetamol (ATC: N02AJ13) will be identified. For each patient, the date of the first DKP-TRAM or tramadol (including tramadol-paracetamol)prescription in the study period will be the index date.

Exclusion criteria
Primary objectives (drug utilisation): Patients 1) with missing data on age or gender, 2) with less than 1-year medical history in the database, 3) aged 17 years or younger.
Secondary objectives (comparative safety): Patients 1) with missing data on age or gender, 2) with less than 1-year medical history in the database, 3) aged 17 years or younger, 4) being prescribed with tramadol (or tramadol-paracetamol) in the entire period (up to 1998 and 2010 for HSD and SIDIAP, respectively) preceding the index date.

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

2828
Study design details

Main study objective

To evaluate pattern of drug use (i.e. indication, dosage and duration) of DKP-TRAM

Outcomes

Indication, duration and dosage of medications use, demographic factors, life style factors, comorbidities, co-medications and prescriber type (GP or specialist). Adverse events (e.g. nausea, vomiting, diarrhoea, vertigo, allucinations and somnolence) in incident users of DKP-TRAM vs. incident user of Tramadol as monotherapy (including fixed combination tramadol-paracetamol), with a special focus on patients 75 year-old and over.

Data analysis plan

Primary objectives: Crude age- and sex- standardised incidence rate (IR) of DKP-TRAM use will be computed, along with descriptive analysis concerning indication, duration and dosage. Continuous variables will be describe as mean with standard deviation or median with interquartile range. Categorical variables will be described as N and percentages. Secondary objectives: The risk of AEs in users of DKP-TRAM will be compared with the risk of AEs in users of tramadol as monotherapy by estimating HR with related 95% confidence intervals (CI) through Cox regression model. Tramadol monotherapy users will be the reference category. All these analysis will be updated with information on data entering the databases in 2018.