Table 2.
Prospective cardiovascular safety trials for SGLT2 inhibitors(9)
Name of Trial | Intervention | Primary Endpoint | No. of Patients | Duration of Trial (y) | Projected Year of Completion |
---|---|---|---|---|---|
Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) | Empagliflozin 10 or 25 mg daily | Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal MI), nonfatal MI, and nonfatal stroke | 7000 | 5 | 2015 |
Canagliflozin cardiovascular Assessment Study (CANVAS) | Canagliflozin 100 or 300 mg daily | Major adverse cardiovascular events, including CV death, nonfatal MI, and nonfatal stroke | 4330 | ≥ 4 | 2017 |
Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy (CREDENCE) | Canagliflozin 100 mg daily | Time to the first occurrence of an event in the primary composite endpoint: ESRD, doubling of serum creatinine, renal or CV death | 3627 | 5.5 | 2019 |
Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events (DECLARE-TIMI58) | Dapagliflozin 10 mg daily | Time to first event included in the composite end point of CV death, MI or ischemic stroke | 17150 | 6 | 2019 |
Cardiovascular Outcomes Following Treatment With Ertugliflozin in Participants With Type 2 Diabetes Mellitus and Established Vascular Disease (NCT01986881) | Ertugliflozin 5 or 15 mg daily | Time to first occurrence of any component of the composite endpoint of CV death, nonfatal MI, or nonfatal stroke | 3900 | 6.3 | 2020 |