Intensive Monitoring in Portugal: a Model to Assess Medicines in Real-Life Conditions. Antidiabetics as example. (MOMI)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Active Surveillance (Intensive Monitoring)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  intensive monitoring schemes

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  SITAGLIPTIN

  VILDAGLIPTIN

  SAXAGLIPTIN

  LINAGLIPTIN

  LIRAGLUTIDE

  EXENATIDE

  DAPAGLIFLOZIN
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• 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:
  1200

Study design details

• Main study objective:
  By pharmacy based tracking of patients and drug usage in a life-cycle based fashion, this model is actively focused on gathering post-authorization data, mainly safety, since the first day of drug use.
• Outcomes:
  - Adverse drug events (ADE) self-reported by patients - (real-world) drug utilization pattern, - Self reported hypoglycemia- Health-related quality of life (EQ-5D)- RCT external validity (Portuguese population)
• Data analysis plan:
  The nr of patients reporting an ADE, the proportion of serious ADE defined according to the CIOMS criteria, and the incidence densities for all ADE during treatment will be calculated. The ADE will be divided into labelled or not labelled according to the European Public Assessment Report (EPAR) of the monitored drug. Generalized Linear Models will be conducted to explore and to identify factors associated with the ADE. Longitudinal models will be used to explore the association of each covariate with time to ADE (time-to-event analysis).Through the patient therapeutic profile, the existence of drug-drug interactions will be identified as well as the eventual existence of drug-disease interactions associated with the monitored drug. The reported monitored drug pattern of use will be described and compared with the one defined in the EPAR. The statistical significance level adopted will be 5% and statistical analysis will be done using the SAS Enterprise Guide v4.1.