Assessment of Utilisation of Pioglitazone in Denmark Post Label Change (July 2011)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  Actos

Population studied

• Short description of the study population:
  Pioglitazone users in Denmark between 11 August 2011 and 15 November 2013.
• Age groups:
  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:
  Type 2 diabetes mellitus patients
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  This drug utilisation study (DUS) aims to assess compliance with prescribing information in Denmark following the July 2011 labelling changes.
• Outcomes:
  To quantify the number of incident and prevalent users of pioglitazone in Denmark after the DHPC letter on11 August 2011, including duration of use among incident users. To describe patterns of antidiabetic co-medication use among incident and prevalentpioglitazone users after the DHPC letter on 11 August 2011.
• Data analysis plan:
  There will be four separate study populations.1. Incident pioglitazone users: all patients with ≥ one new prescription (first-time prescription only, or first-time prescription and following prescriptions) for pioglitazone between 11 August 2011 and 31 December 2014, who have not had any pioglitazone prescription recorded in the 12 months prior to 11 August 2011. Patients are eligible if they have at least 12 months of data recorded prior to the index date for incident users, i.e. date of the first-time pioglitazone prescription.2. Prevalent pioglitazone users: all patients with ≥ one prescription for pioglitazone between 11 August 2011 and 31 December 2014, who also had ≥ one pioglitazone prescription recorded prior to 11 August 2011. Patients are eligible if they have at least 12 months of data recorded prior to index date for prevalent users, i.e. prior to 11 August 2011.

Documents

Study results

Study_report_abstract