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. 2019 Apr 24;16(4):303–309. doi: 10.1177/1479164119842339

Table 1.

The major clinical trials evaluating the cardiovascular safety of DPP4i in type 2 diabetes.

Trial Compound evaluated Year published Participants randomized Median follow-up time (years) MACE definition Main inclusion criteria at baseline
EXAMINE Alogliptin 2013 5380 1.5 3P: cardiovascular death, non-fatal MI or stroke Recent myocardial infarction or unstable angina requiring hospitalization
HbA1c: 6.5%–11.0% (7%–11.0% when on insulin)
SAVOR-TIMI 53 Saxagliptin 2013 16,492 2.1 3P: cardiovascular death, non-fatal MI or stroke History of, or high risk for, cardiovascular disease
>40 years old
HbA1c: 6.5%–12.0%
TECOS Sitagliptin 2015 14,735 3.0 4P: cardiovascular death, non-fatal MI or stroke, or hosp. unstable angina Established cardiovascular disease
>50 years old
HbA1c: 6.5%–8%
CARMELINA Linagliptin 2018 6991 2.2 3P: cardiovascular death, non-fatal MI or stroke High cardiovascular (prior CVD or albuminuria) and renal risk
HbA1c: 6.5%–10.0%

EXAMINE3: Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care; SAVOR-TIMI 535: Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus – Thrombolysis in Myocardial Infarction; TECOS4: Trial Evaluating Cardiovascular Outcomes with Sitagliptin; CARMELINA7,8: Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus; MACE: major adverse cardiovascular events; MI: myocardial infarction; 3P: 3-point; 4P: 4-point; HbA1c: glycated haemoglobin; CVD: cardiovascular disease.

Data were derived from the literature.35,7,8