Table 2.
CVOTs completed in 2016/17 and published in 2017: comparison of results vs. placebo
| CANVAS program [13] | EXSCEL [14] | DEVOTE [15] | ACE [17] | FOURIER [18] | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular endpoints | Class | HR (95% CI) p value |
Class | HR (95% CI) p value |
Class | HR (95% CI) p value |
Class | HR (95% CI) p value |
Class | HR (95% CI) p value |
| Primary Composite MACE | CV death, MI or stroke |
0.86 (0.75–0.97) 0.02a |
CV death, MI or stroke | 0.91 (0.83–1.00) 0.06a |
CV death, MI or stroke | 0.91 (0.78–1.06) <0.001 |
CV death, MI, stroke, UA and HF |
0.98 (0.86–1.11) 0.73 |
CV death, MI, stroke, UA and coronary re-vascularisation | 0.85 (0.79–0.92) <0.001 |
| Cardiovascular death | Primary endpoint |
0.87 (0.72–1.06) – |
Secondary endpoint | 0.88 (0.76–1.02) – |
Primary endpoint |
0.96 (0.76–1.21) 0.71 |
Secondary endpoint | 0.89 (0.71–1.11) 0.29 |
Secondary endpoint | 1.05 (0.88–1.25) 0.62 |
| Myocardial infarction | Primary endpoint |
0.89 (0.73–1.09) – |
Secondary endpoint | 0.97 (0.85–1.10) – |
Primary endpoint |
0.85 (0.68–1.06) 0.15 |
Secondary endpoint | 1.12 (0.87–1.46) 0.38 |
Secondary endpoint | 0.73 (0.65–0.82) <0.001 |
| Stroke | Primary endpoint | 0.87 (0.69–1.09) – |
Secondary endpoint | 0.85 (0.70–1.03) – |
Primary endpoint | 0.90 (0.65–1.23) 0.50 |
Secondary endpoint | 0.97 (0.70–1.33) 0.83 |
Secondary endpoint | 0.79 (0.66–0.95) 0.01 |
| Hospitalisation for unstable angina | – | – – |
– | – – |
Primary endpoint |
0.95 (0.68–1.31) 0.74 |
Secondary endpoint | 1.02 (0.82–1.26) 0.87 |
Secondary endpoint | 0.99 (0.82–1.18) 0.89 |
| Hospitalisation for heart failure | Secondary endpoint | 0.67 (0.52–0.87) – |
Secondary endpoint | 0.94 (0.78–1.13) – |
– | – – |
Secondary endpoint | 0.89 (0.63–1.24) 0.48 |
– | – – |
| Event rate (%) active group |
Event rate (%) active group |
Event rate (%) active group |
Event rate (%) active group |
Event rate (%) active group |
||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Primary composite MACE | 26.9b | 11.4 | 8.5 | 14.4 | 9.8 | |||||
| No. (%) p-value |
No. (%) p-value |
No. (%) p-value |
No. (%) p-value |
No. (%) p-value |
||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Renal event | 19.7b 0.32 |
55 (0.7) – |
3.8 (–) – |
– (–) – |
– (–) – |
|||||
| Acute pancreatitis | 0.5b 0.63 |
26 (0.4) – |
– (–) – |
– (–) – |
– (–) – |
|||||
| Hypoglycaemia events | 50.0b 0.20 |
247 (3.4)c – |
4.9 (–)c <0.001a |
54 (2)c 0.95 |
– (–) – |
|||||
aSuperiority test
bNumber of participants per 1000 patient-year
cSevere hypoglycaemia events