From: Continued efforts to translate diabetes cardiovascular outcome trials into clinical practice
 | SAVOR | TECOS | EXAMINE | ORIGIN | ELIXA | LEADER | EMPA-REG |
---|---|---|---|---|---|---|---|
Trial characteristic | |||||||
 Drug | Saxagliptin | Sitagliptin | Alogliptin | Glargine | Lixisenatide | Liraglutide | Empagliflozin |
 Comparator | Placebo | Placebo | Placebo | Placebo | Placebo | Placebo | Placebo |
 No. patients | 16492 | 14671 | 5380 | 12537 | 6068 | 9340 | 7020 |
 Duration, years | 2.1 | 3.0 | 1.5 | 6.2 | 2.1 | 3.8 | 3.1 |
 Primary endpoint | 3-point MACE | 4-point MACE | 3-point MACE | 3-point MACE | 3-point MACE | 3-point MACE | 3-point MACE |
 Major secondary endpoint | 3-point MACE + hospitalization for unstable angina, coronary revasc. or HHF | 3-point MACE | 3-point MACE + urgent revasc. for unstable angina | 3-point MACE + revasc. or HHF (co-primary) | 3-point MACE + HHF or revasc. | 3-point MACE + coronary revasc. or hospitalization for unstable angina or HHF | 4-point MACE |
Pts characteristics | |||||||
 Age, years (mean ± SD) | 65.0 ± 8.5 | 65.5 ± 8.0 | 61.0 (median) | 63.6 ± 7.8 | 60.3 ± 9.6 | 64.3 ± 7.2 | 63.1 ± 8.7 |
 Diabetes duration, years | 10.3 (IQR 5.2–16.7) | 11.6 ± 8.1 | 7.2 (IQR 2.7–13.7) | 5.4 ± 6.0 | 9.3 ± 8.2 | 12.8 ± 8.1 | 57.4 % > 10 years |
 Baseline HbA1c | 8.0 ± 1.4 | 7.2 ± 0.5 | 8.0 ± 1.1 | 6.4 (IQR 5.8–7.2) | 7.6 ± 1.3 | 8.7 ± 1.5 | 8.1 ± 0.8 |
 Baseline BMI | 31.1 ± 5.6 | 30.2 ± 5.6 | 28.7 (IQR 5.6–68.3) | 29.8 ± 5.2 | 30.2 ± 5.7 | 32.5 ± 6.3 | 30.7 ± 5.3 |
 Insulin users,  % | 41.4 | 23.2 | 29.9 | 0 | 39.1 | 44.5 | 48.3 |
 % with CVD | 78.5 | 74.0 | 100 | 58.9 | 100 | 81.3 | 75.6 (CAD) |
 % with eGFR <60 ml/min/1.73 m2 | 15.6 | 9.4 % (<50 ml/min/1.73 m2) | 29.1 | N/A | 23.2 | 23.1 | 26.0 |
 Annual event rate in placebo arm,  % | 3.5 | 3.8 | 7.9 | 2.9 | 6.3 | 3.9 | 4.4 |
CV outcome | |||||||
 HR primary endpoint (95 % C.I.) | 1.00 (0.89–1.12) | 0.98 (0.88–1.09) | 0.96 (≤1.16) | 1.02 (0.94–1.11) | 1.02 (0.89–1.17) | 0.87 (0.78–0.97)* | 0.86 (0.74–0.99)* |
 HR secondary endpoint (95 % C.I.) | 1.02 (0.94–1.11) | 0.99 (0.89–1.11) | 0.95 (≤1.14) | 1.04 (0.97–1.11) | 0.97 (0.85–1.10) | 0.88 (0.81–0.96) | 0.89 (0.78–1.01) |
 HR HHF (95 % C.I.) | 1.27 (1.07–1.51)* | 1.00 (0.83–1.20) | 1.07 (0.79–1.46) | 0.90 (0.77–1.05) | 0.96 (0.75–1.23) | 0.87 (0.73–1.05) | 0.65 (0.50–0.85)* |
 HR CV death (95 % C.I.) | 1.03 (0.87–1.22) | 1.08a | 0.79 (0.60–1.04) | 1.00 (0.89–1.13) | 0.93a | 0.68 (0.66–0.93) | 0.62 (0.49–0.77)* |
 HR any death (95 % C.I.) | 1.11 (0.96–1.27) | 1.03a | 0.88 (0.71–1.09) | 0.98 (0.90–1.08) | 0.94 (0.78–1.13) | 0.85 (0.74–0.97) | 0.68 (0.57–0.82)* |
 NNT primary endpoint (3 years) | N/A | N/A | N/A | N/A | N/A | 66 | 61 |
 NNT death (3 years) | N/A | N/A | N/A | N/A | N/A | 98 | 39 |
Efficacy | |||||||
 HbA1c change,  % | −0.3* | −0.3* | −0.36* | −0.3* | −0.4* | −0.4* | −0.3* |
 Body weight change, kg | −0.4 | N/A | Neutral | +1.1* | −0.6* | −2.3* | −1.4* |
 Renal endpoints | Albuminuria improved | No effect | No effect | No effect | Lower increase in albuminuria | Lower rate of nephropathy events | Lower progression of CKD |