Drug utilization study of mirabegron (Betmiga®) using real-world healthcare databases from the Netherlands, Spain, United Kingdom and Finland (Mirabegron DUS)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary data collection
• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  100000144773

  mirabegron
• Medical condition to be studied:
  Hypertension

Population studied

• Short description of the study population:
  Mirabegron initiators during the years 2012-2016.
• 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)
• Estimated number of subjects:
  50000

Study design details

• Main study objective:
  The objectives are to assess the effectiveness of the DHPC letter as a risk minimization measure by quantifying the proportions of mirabegron initiators with severe uncontrolled hypertension (primary objective) and the frequency of blood pressure recordings at baseline and during mirabegron treatmen
• Outcomes:
  For the primary objective we will assess whether the proportions of mirabegron initiators with documented hypertension (severe uncontrolled hypertension but also controlled hypertension or non-severe uncontrolled hypertension) differ between the time periods before and after DHPC dissemination. For the secondary objective we will asses whether the frequency of blood pressure recordings at initiation and during mirabegron treatment among initiators with documented hypertension at index date differ between the time periods before and after DHPC dissemination.
• Data analysis plan:
  The DHCP letter was disseminated on 7 September 2015. The analysis pre- and post dissemination will take this date as the intervention date. Besides a pre- and post dissemination analysis, incremental changes over time will be assessed using the aggregated data per quarter (January-March, April-June, July-September and October-December). To estimate incremental changes in response to the DHPC letter in the proportion of mirabegron initiators with normal blood pressure, controlled hypertension, non-severe uncontrolled hypertension and severe uncontrolled hypertension at index date (primary objective), an interrupted time series approach will be applied on the respective proportions in each quarter.The frequency of blood pressure recordings will be assessed before initiation of and during mirabegron treatment (see section 9.3.4). Blood pressure recordings at or before index date (up to 6 months) will be reported separately from the recordings during treatment.

Documents

Results tables

178-pv-002-clgr-disc01-en-final-04