Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Ecological
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(A10BG02) rosiglitazone
rosiglitazone
Population studied

Short description of the study population

Diabetic population using oral antidiabetic drugs.

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)
Adolescents (12 to < 18 years)
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)

Special population of interest

Other

Special population of interest, other

Diabetes mellitus patients

Estimated number of subjects

0
Study design details

Main study objective

To assess the impact of rosiglitazone safety alerts on trends in the sale of rosiglitazone and other oral anti diabetic drugs.

Outcomes

Sales of rosiglitazone in Portugal from January 2002 to December 2012, Sales of all oral antidiabetic drugs in Portugal from January 2002 to December 2012

Data analysis plan

We conducted an ecological study, using temporally aggregated data and linking safety alerts to country-wide sales of all oral antidiabetic drugs in Portugal from January 2002 to December 2012