TARGET-EU: Dapagliflozin and major adverse cardiovascular events in type 2 diabetes

ENCePP Code of conduct

Yes

Data sources

• Data source(s):
  Clinical Practice Research Datalink

  BIFAP - Base de Datos para la Investigación Farmacoepidemiológica en el Ámbito Público (Pharmacoepidemiological Research Database for Public Health Systems)
• Data sources (types):
  Electronic healthcare records (EHR)

Use of a Common Data Model (CDM)

• CDM mapping:
  Yes

CDM Mappings

• CDM name:
  ConcepTION CDM
• CDM website:
  https://www.imi-conception.eu/
• CDM release frequency:
  6 months

• CDM version:
  V 2.2

Data quality specifications

• Check conformance:
  Yes
• Check completeness:
  Yes
• Check stability:
  Yes
• Check logical consistency:
  Yes

Data characterisation

• Data characterisation conducted:
  Yes
• Data characterisation details:
  The feasibility assessment for this case study, detailed in the appendix of the study protocol, was conducted as part of the broader TARGET-EU feasibility assessment (EUPAS1000000791). Data source suitability was evaluated using a structured framework based on the EMA data quality framework, assessing system characteristics, data quality, and fitness for the research question.; ; Briefly, both CPRD and BIFAP were deemed feasible for studying dapagliflozin versus DPP-4 inhibitors on MACE, with sufficient sample size and exposure prevalence. BIFAP offers broad population coverage but has limitations, including delayed and incomplete mortality data, partial capture of hospital events, and inferred treatment discontinuation. CPRD provides timely, high-quality prescription data but lacks dispensing information and may have incomplete diagnostic coding in some settings.