Table 2.
Key GLP-1RA RCTs with cardiovascular and renal endpoints.
Drug (Ref) | Trial | n | Studied Population | Mean Duration | Composite Primary CV Endpoint |
Result HR (95% CI; p) |
Individual Primary CV Endpoint |
Result HR (95% CI; p) |
---|---|---|---|---|---|---|---|---|
Lixisenatide [45] | ELIXA | 6068 | T2D and acute coronary syndrome | 25 m | 3P-MACE | Neutral | None | Neutral |
Exenatide [46] | EXSCEL | 14,752 | T2D with or without CVD | 3.2 y | 3P-MACE | Neutral | None | Neutral |
Liraglutide [19,47] | LEADER | 9340 | T2D and high CV risk | 3.8 y | 3P-MACE | 0.87 (0.78–0.97; p < 0.001) | Death from any cause | 0.85 (0.74–0.97; p = 0.02) |
Semaglutide [20] (sc) | SUSTAIN-6 | 3297 | T2D 50 y or more with established CVD, CHF or CKD G3 or higher or >60 y w/CV risk factor |
2.1 y | 3P-MACE | 0.74 (0.58–0.95; p = 0.02) | Nonfatal stroke | 0.61 (0.38–0.99; p = 0.04) |
Albiglutide [48] | HARMONY | 9469 | T2D and CVD or CV risk factors | 3.8 y | 3P-MACE | 0.78 (0.68–0.90; p = 0.0006) | Fatal or nonfatal myocardial infarction | 0.75 (0.61–0.90, p = 0.003) |
Dulaglutide [28] | REWIND | 9901 | T2D and CVD or CV risk factors | 5.4 y | 3P-MACE | 0.88 (0.79–0.99; p = 0.026) | Nonfatal Stroke | 0.76 (0.61–0.95; p = 0.017) |
Semaglutide [49] (oral) | PIONEER-6 | 3183 | T2D and CVD or CV risk factors | 15.9 m | 3P-MACE | Neutral | None | Neutral |
Exenatide [22] | FREEDOM-CVO | 4000 | T2D and CV disease | UK | UK | UK | UK | UK |
T2D, type 2 diabetes mellitus; CVD, Cardiovascular disease; 3P-MACE, 3-point MACE (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke); SC; subcutaneous, UK, unknown; y, years; m, Month; RCTs: randomized clinical trial.