Table 4.
Comparison of outcome results from terminated CVOTs in comparison to placebo
| Cardiovascular endpoints | SAVOR-TIMI53 [43, 45] | EXAMINE [47, 48] | TECOS [50] | ELIXA [44] | EMPA-REG OUTCOME [48, 49] | LEADER [51] | SUSTAIN-6 [52] | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Class | Hazard ratio (95 % CI) p value |
Class | Hazard ratio (95 % CI) p value |
Class | Hazard ratio (95 % CI) p value |
Class | Hazard ratio (95 % CI) p value |
Class | Hazard ratio (95 % CI) p value |
Class | Hazard ratio (95 % CI) p value |
Class | Hazard ratio (95 % CI) p value |
|
| Primary composite MACE | CV death, MI, or stroke | 1.00 (0.89-1.12) 0.99 |
CV death, MI, or stroke | 0.96 (≤1.16) 0.315 |
CV death, MI, UA, or stroke | 0.98 (0.89–1.08) 0.65 |
CV death, MI, UA, or stroke | 1.02 (0.89–1.17) 0.81 |
CV death, MI, or stroke | 0.86 (0.74–0.99) 0.04a |
CV death, MI, or stroke | 0.87 (0.78–0.97) 0.01 |
CV death, MI, or stroke | 0.74 (0.58–0.95) <0.001/0.02a |
| Cardiovascular death | Primary end-point | 1.03 (0.87–1.22) 0.72 |
Primary end-point | 0.85 (0.66–1.10) 0.212 |
Primary end-point | 1.03 (0.89–1.19) 0.71 |
Primary end-point | 0.98 (0.78–1.22) 0.85 |
Primary end-point | 0.62 (0.49–0.77) < 0.001 |
Primary end-point | 0.78 (0.66–0.93) 0.007 |
Primary end-point | 0.98 (0.65–1.48) 0.92 |
| Myocardial infarction | Primary end-point | 0.95 (0.80–1.12) 0.52 |
Primary end-point | 1.08 (0.88–1.33) 0.47 |
Primary end-point | 0.95 (0.81–1.11) 0.49 |
Primary end-point | 1.03 (0.87–1.22) 0.71 |
Primary end-point | 0.87 (0.70–1.09) 0.23 |
Primary end-point | 0.86 (0.73–1.00) 0.046 |
Primary end-point | 0.74 (0.51–1.08) 0.12 |
| Stroke | Primary end-point | 1.11 (0.88–1.39) 0.38 |
Primary end-point | 0.91 (0.55–1.50) 0.71 |
Primary end-point | 0.97 (0.79–1.19) 0.76 |
Primary end-point | 1.12 (0.79–1.58) 0.54 |
Primary end-point | 1.18 (0.89–1.56) 0.26 |
Primary end-point | 0.86 (0.71–1.06) 0.16 |
Primary end-point | 0.61 (0.38–0.99) 0.04 |
| Hospitalization for unstable angina | Secondary end-point | 1.19 (0.89–1.60) 0.24 |
Secondary end-point | 0.90 (0.60–1.37) 0.632 |
Primary end-point | 0.90 (0.70–1.16) 0.42 |
Primary end-point | 1.11 (0.47–2.62) 0.81 |
Secondary end-point | 0.99 (0.74–1.34) 0.97 |
Extended Primary end-point |
0.98 (0.76–1.26) 0.87 |
Extended primary end-point | 0.82 (0.47–1.44) 0.49 |
| Hospitalization for heart failure | Secondary end-point | 1.27 (1.07–1.51) 0.007 |
Extended Primary end-point |
1.19 (0.90-1.58) 0.220 |
Secondary end-point | 1.00 (0.83–1.20) 0.98 |
Secondary end-point | 0.96 (0.75-1.23) 0.75 |
Secondary end-point | 0.65 (0.50–0.85) 0.002 |
Extended Primary end-point |
0.87 (0.73-1.05) 0.14 |
Extended primary end-point | 1.11 (0.77–1.61) 0.57 |
| Event rate (%) active group | Event rate (%) active group | Event rate (%) active group | Event rate (%) active group | Event rate (%) active group | Event rate (%) active group | Event rate (%) active group | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. (%) p value |
No. (%) p value |
No. (%) p value |
No. (%) p value |
No. (%) p value |
No. (%) p value |
No. (%) p value |
||||||||
| Primary composite MACE | 7.3 | 11.3 | 9.6 | 13.4 | 10.5 | 13.0 | 6.6 | |||||||
| Non-cardiovascular endpoints | ||||||||||||||
| Renal event | 2.0 % 0.46 |
0.9 % 0.88 |
1.5 % | 1.6 % | 5.2 % | 5.7 % | 3.8 % | |||||||
| Acute pancreatitis | 0.3 % 0.17 |
0.4 % 0.5 |
0.3 % 0.12 |
0.2 % | 0.3 %b | 0.4 % 0.44 |
0.54 % | |||||||
| Hypoglycemia events | 0.5 % 0.33 |
0.7 % 0.86 |
1.9 % 0.33 |
0.6 % | 1.3 % | 3.3 % 0.02 |
22.4 %c | |||||||
aSuperiority test
bAverage across all age ranges
cSevere hypoglycemia as defined by ADA