Prevalence of Cardiovascular Disease in Swedish Patients With Type 2 Diabetes and in Patients Initiating on Empagliflozin

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medicinal product name:
  JARDIANCE
• Study drug International non-proprietary name (INN) or common name:
  EMPAGLIFLOZIN
• Additional medical condition(s):
  Cardiovascular disease

Population studied

• Short description of the study population:
  The broad study population will include patients with T2DM and at least one registration in the NDR (at any time from start of registry until 2017) and who are alive on 2015-01-01.

Study design details

• Study design:
  Non-interventional, cross-sectional study
• Main study objective:
  The primary objectives of this study are:;  Prevalence of a history of cardiovascular disease (according to the EMPAREG outcome trial definition)among persons with T2DM who were alive on 31 December 2017;  Prevalence of a history of cardiovascular disease among persons with type 2 diabetes who started empagliflozin treatment between 1 January 2015 and 31 December 2017
• Summary results:
  A total of 460 558 patients with T2DM patients who were alive on 2017-12-31 and with at least one registration in the NDR were identified. Patients identified with established cardiovascular disease were 130508 (28,3%), and without cardiovascular disease were 330050 (71,7%). A total of 16985 patients who started with empagliflozin (11,5 %) were identified through SPDR and were also registered as having T2DM in NDR, of which 1952 patients (11,5%) had CVD. The prevalence of T2DM patients with established CVD according to EMPA-REG OUTCOME trial study definition was 28.3%. Corresponding percentage in the patients who initiated on empagliflozin during 2015-2017 was 11.5%.