Research Article

How Many Patients with Type 2 Diabetes Meet the Inclusion Criteria of the Cardiovascular Outcome Trials with SGLT2 Inhibitors? Estimations from a Population Database in a Mediterranean Area

Table 4

Eligibility criteria for the DECLARE-TIMI 58 trial (dapagliflozin) and number of patients in the SIDIAP database that would have met criteria for enrolment.

Eligibility in the DELCLARE-TIMI 58 trialPotentially eligible patients from the SIDIAP database ()

Inclusion criteriaIn PP, (%)In SP, (%)
 Age:
(i) In PP: ≥55 years; ≥60 in women
(ii) In SP: ≥40
175,092 (46.9); 140,941 (37.8)

368,963 (98.9)
 Primary prevention cohort
  ≥55 years (≥60 in women) and ≥1 CVRF:
(i) Dyslipidemia
(ii) Hypertension
(iii) Current smoker
289,126 (77.5)
 Secondary prevention cohort
  ≥40 years and history of CV events (CHD, angina, MI, stroke, and PAD)86,468 (23.2)
 HbA1c 6.5%-<12%165,777 (44.4)50,872 (13.6)
Main exclusion criteriaIn PPIn SP
53,851 (14.4)21,145 (5.7)
Total eligible in PP and SP, (%)111,926 (30)29,727 (7.9)
Total eligible, (%)141,653 (38%)

CHD: coronary heart disease; CV: cardiovascular; CVRF: cardiovascular risk factors; eGFR: estimated glomerular filtration rate; MI: myocardial infarction; PAD: peripheral artery disease; PP: primary cardiovascular prevention; SP: secondary cardiovascular prevention; HbA1c: glycated haemoglobin. All the percentages refer to the proportion from the total number of eligible subjects of the SIDIAP database ().