From: Correction to: Updates on cardiovascular outcome trials in diabetes
SAVOR-TIMI53 [1, 2] | EXAMINE [3, 4] | TECOS [5] | ELIXA [6] | EMPA-REG OUTCOME [7] | LEADER [8] | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Class | HR (95% CI) | Class | HR (95% CI) | Class | HR (95% CI) | Class | HR (95% CI) | Class | HR (95% CI) | Class | HR (95% CI) | |
p value | p value | p value | p value | p value | p value | |||||||
Cardiovascular endpoints | ||||||||||||
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) 0.32 | 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 |
Cardiovascular death | Primary endpoint | 1.03 (0.87–1.22) 0.72 | Primary endpoint | 0.79 (0.60–1.04) 0.10 | Secondary endpoint | 1.03 (0.89–1.19) 0.71 | Primary endpoint | 0.98 (0.78–1.22) 0.85 | Primary endpoint | 0.62 (0.49–0.77) < 0.001 | Primary endpoint | 0.78 (0.66–0.93) 0.007 |
Myocardial infarction | Primary endpoint | 0.95 (0.80–1.12) 0.52 | Primary endpoint | 1.08 (0.88–1.33) 0.47 | Secondary endpoint | 0.95 (0.81–1.11) 0.49 | Primary endpoint | 1.03 (0.87–1.22) 0.71 | Primary endpoint | 0.87 (0.70–1.09) 0.23 | Primary endpoint | 0.86 (0.73–1.00) 0.046 |
Stroke | Primary endpoint | 1.11 (0.88–1.39) 0.38 | Primary endpoint | 0.91 (0.55–1.50) 0.71 | Secondary endpoint | 0.97 (0.79–1.19) 0.76 | Primary endpoint | 1.12 (0.79–1.58) 0.54 | Primary endpoint | 1.18 (0.89–1.56) 0.26 | Primary endpoint | 0.86 (0.71–1.06) 0.16 |
Hospitalization for unstable angina | Secondary endpoint | 1.19 (0.89–1.60) 0.24 | Secondary endpoint | 0.90 (0.60–1.37) 0.632 | Secondary endpoint | 0.90 (0.70–1.16) 0.42 | Primary endpoint | 1.11 (0.47–2.62) 0.81 | Secondary endpoint | 0.99 (0.74–1.34) 0.97 | Extended primary endpoint | 0.98 (0.76–1.26) 0.87 |
Hospitalization for heart failure | Secondary endpoint | 1.27 (1.07–1.51) 0.007 | Extended primary endpoint | 1.19 (0.90–1.58) 0.220 | Secondary endpoint | 1.00 (0.83–1.20) 0.98 | Secondary endpoint | 0.96 (0.75–1.23) 0.75 | Secondary endpoint | 0.65 (0.50–0.85) 0.002 | Extended primary endpoint | 0.87 (0.73–1.05) 0.14 |
Event rate (%) active group | Event rate (%) active group | Event rate (%) active group | Event rate (%) active group | Event rate (%) active group | Event rate (%) active group | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Primary composite MACE | 7.3 | 11.3 | 9.6 | 13.4 | 10.5 | 13.0 |
No. (%) p value | No. (%) p value | No. (%) p value | No. (%) p value | No. (%) p value | No. (%) p value | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Non-cardiovascular endpoints | ||||||||||||
Renal event | 5.8 0.04 | 0.9 0.88 | 1.4 – | 1.6 – | 5.2 – | 5.7 0.003 | ||||||
Acute pancreatitis | 0.3 0.77 | 0.4 0.5 | 0.3 0.07 | 0.2 – | 0.3b – | 0.4 0.44 | ||||||
Hypoglycemia events | 15.3 < 0.001 | 6.7 0.74 | 2.2 0.33 | 16.6 0.14 | 2.8 | 2.4 0.02 |
SUSTAIN 6 [9] | EXSCEL [10] | DEVOTE [11] | CANVAS program [12] | ACE [13] | ||||||
---|---|---|---|---|---|---|---|---|---|---|
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 | |
Cardiovascular endpoints | ||||||||||
Primary composite MACE | CV death, MI, or stroke | 0.74 (0.58–0.95) 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 or stroke | 0.86 (0.75–0.97) 0.02a | CV death, MI, stroke, UA and HF | 0.98 (0.86–1.11) 0.73 |
Cardiovascular death | Primary endpoint | 0.98 (0.65–1.48) 0.92 | Secondary endpoint | 0.88 (0.76–1.02) | Primary endpoint | 0.96 (0.76–1.21) 0.71 | Primary endpoint | 0.87 (0.72–1.06) | Secondary endpoint | 0.89 (0.71–1.11) 0.29 |
Myocardial infarction | Primary endpoint | 0.74 (0.51–1.08) 0.12 | Secondary endpoint | 0.97 (0.85–1.10) | Primary endpoint | 0.85 (0.68–1.06) 0.15 | Primary endpoint | 0.89 (0.73–1.09) | Secondary endpoint | 1.12 (0.87–1.46) 0.38 |
Stroke | Primary endpoint | 0.61 (0.38–0.99) 0.04 | Secondary endpoint | 0.85 (0.70–1.03) | Primary endpoint | 0.90 (0.65–1.23) 0.50 | Primary endpoint | 0.87 (0.69–1.09) | Secondary endpoint | 0.97 (0.70–1.33) 0.83 |
Hospitalization for unstable angina | Extended primary endpoint | 0.82 (0.47–1.44) 0.49 | – | – | Primary endpoint | 0.95 (0.68–1.31) 0.74 | – | – | Secondary endpoint | 1.02 (0.82–1.26) 0.87 |
Hospitalization for heart failure | Extended primary endpoint | 1.11 (0.77–1.61) 0.57 | Secondary endpoint | 0.94 (0.78–1.13) | – | – | Secondary endpoint | 0.67 (0.52–0.87) | 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 | 6.6 | 11.4 | 8.5 | 26.9d | 14.4 |
No. (%) p value | No. (%) p value | No. (%) p value | No. (%) p value | No. (%) p value | |
---|---|---|---|---|---|
Non-cardiovascular endpoints | |||||
Renal event | 3.9 – | 55 (0.7) | 3.8 – | 19.7d 0.32 | – |
Acute pancreatitis | 0.55 – | 26 (0.4) | – – | 0.5d 0.63 | – |
Hypoglycemia events | 22.4c – | 247 (3.4) | 4.9 < 0.001a | 56.0d 0.20 | 54 (2) 0.95 |