Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation

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

(A10BD03) metformin and rosiglitazone
metformin and rosiglitazone
(A10BD04) glimepiride and rosiglitazone
glimepiride and rosiglitazone
(A10BG02) rosiglitazone
rosiglitazone
Population studied

Short description of the study population

The study population will include, in both countries, diabetic patients treated with oral glucose lowering drugs between 1 January 2000 and 1 January 2011. This period covers the time from the approval of rosiglitazone for use in the European Union, in July 2000, until the decision by the European Medicines Agency to suspend the drug, on 23 September 2010. The study period also includes a pre-approval and a post-suspension periods to allow examination of drug utilization
patterns in response to these events.

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

20000
Study design details

Main study objective

To describe trends in patterns of utilisation of rosiglitazone-containing preparations over time in response to risk minimsation events (switches to and from rosiglitazone-containing preparations),To examine prevalence of ontraindicated and offlabel use,To examine risk of acute drug reactions after risk minimisationTo examine changes in objective parameters of disease in medication switchers

Data analysis plan

1.Descriptive drug utlization patterns according to calendar time2. Prevalences of off-label and contraindicated use3. Incidence rates and rate ratios of acute drug reactions according to patterns of oral antidiabetic use4. Changes in laboratory parameters of disease comparing values before and after medication switch/regulatory decisions5. Risk of lab-based disease events