TABLE 4.
GLP1ra Cardiovascular Outcomes Trials
| ELIXA (93) | LEADER (94) | SUSTAIN-6 (95) | EXSCEL (96) | HARMONY (97) | REWIND (98) | PIONEER 6 (92) | |
|---|---|---|---|---|---|---|---|
| Lixisenatide (n = 6,068) | Liraglutide (n = 9,340) | Semaglutide (n = 3,297) | Exenatide QW (n = 14,752) | Albiglutide QW (n = 9,463) | Dulaglutide QW (n = 9,901) | Oral Semaglutide (n = 3,183) | |
| Median follow-up, yrs | 2.1 | 3.8 | 2.1 | 3.2 | 1.6 | 5.4 | 1.3 |
| Mean age, yrs | 60 | 64 | 54 | 62 | 64 | 66 | 66 |
| Female, % | 30 | 36 | 39 | 38 | 31 | 46 | 32 |
| BMI, kg/m2, mean | 30.2 | NA | NA | NA | 32.3 | 32.3 | 32.3 |
| HbA1c, % | 7.7 | 8.7 | 8.7 | 8.1 | 8.8 | 7.3 | 8.2 |
| Baseline eGFR, ml/min, mean | 76 | 75 | 75 | 76 | 79 | 75 | 74 |
| eGFR <60 ml/min, % | 23 | 23 | 28.5 | 18 | 23 | 22 | 27 |
| Prior CVD, % | 100 | 81 | 83 | 73 | 100 | 32 | 85 |
| Prior HF, % | 22 | 18 | 24 | 16 | 20 | 9 | 12 |
| 3P-MACE | 1.02 (0.89–1.17) | 0.87 (0.78–0.97) | 0.74 (0.58–0.95) | 0.91 (0.83–1.00) | 0.78 (0.68–0.90) | 0.88 (0.79–0.99) | 0.79 (0.51–1.11) |
| CV death | 0.98 (0.78–1.22) | 0.78 (0.66–0.93) | 0.98 (0.65–1.48) | 0.88 (0.76–1.02) | 0.93 (0.73–1.19) | 0.91 (0.78–1.06) | 0.49 (0.27–0.92) |
| Nonfatal MI | 1.03 (0.87–1.22) | 0.86 (0.73–1.00) | 0.74 (0.51–1.08) | 0.95 (0.84–1.09) | 0.75 (0.61–0.90)** | 0.96 (0.79–1.16) | 1.18 (0.73–1.90) |
| Nonfatal stroke | 1.12 (0.79–1.58) | 0.86 (0.71–1.06) | 0.61 (0.38–0.99) | 0.86 (0.70–1.07) | 0.86 (0.66–1.14) | 0.76 (0.61–0.95) | 0.74 (0.35–1.57) |
| All-cause mortality | 0.94 (0.78–1.13) | 0.85 (0.74–0.97) | 1.05 (0.74–1.50) | 0.86 (0.77–0.97) | 0.95 (0.79–1.16) | 0.90 (0.80–1.01) | 0.51 (0.31–0.84) |
| HHF | 0.96 (0.75–1.23) | 0.87 (0.73–1.05) | 1.11 (0.77–1.61) | 0.94 (0.78–1.13) | NA | 0.93 (0.77–1.12) | 0.86 (0.48–1.55) |
| Renal events* | 0.81 (0.66–0.99) | 0.78 (0.67–0.92) | 0.64 (0.46–0.88) | 0.85 (0.73–0.98) | NA | 0.85 (0.77–0.93) | NA |
Values in parenthesis are HR (95% CI).
Values in bold are statistically significant at p < 0.05.
Definition varied across trials.
Hazard ratio for fatal or non-fatal MI.
ELIXA = Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010; EXSCEL = Exenatide Study of Cardiovascular Event Lowering Trial; HARMONY = Albiglutide and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Cardiovascular Disease; LEADER = Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results; PIONEER-6 = Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes; REWIND = Researching cardiovascular events with a Weekly INcretin in Diabetes; SUSTAIN-6 = Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes; other abbreviations as in Table 3.