Background
Main body
Study status | Drug | Drug class | Intervention | Primary outcome | N | Follow-up (years) | Start and estimated end date | Clinicaltrials.gov ID | |
---|---|---|---|---|---|---|---|---|---|
EMPA-REG | Completed | Empagliflozin | SGLT-2 inhibitor | Empagliflozin 10 mg versus empagliflozin 25 mg versus placebo | CV death, MI, or stroke | 7000 | 3.1 | 07.2010 to 04.2015 | NCT01131676 |
LEADER | Completed | Liraglutide | GLP-1 inhibitor | Liraglutide versus placebo | CV death, MI, or stroke | 9340 | 3.8 | 08.2010 to 12.2015 | NCT01179048 |
SUSTAIN-6 | Completed | Semaglutide | GLP-1 inhibitor | Semaglutide 0.5 mg versus semaglutide 1.0 mg versus placebo | CV death, MI, or stroke | 3299 | 1.99 | 02.2013 to 01.2016 | NCT01720446 |
Cardiovascular endpoints | LEADER [6] | SUSTAIN-6 [7] | ||||
---|---|---|---|---|---|---|
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 | 0.86 (0.74–0.99) 0.04* | CV death, MI, or stroke | 0.87 (0.78–0.97) 0.01 | CV death, MI, or stroke | 0.74 (0.58–0.95) <0.001/0.02* |
Cardiovascular death | 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 | 0.87 (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 | 1.18 (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 | 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 | 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 |
Primary composite MACE | Event rate (%) active group | Event rate (%) active group | Event rate (%) active group | |||
10.5 | 13.0 | 6.6 |
Non-cardiovascular endpoints | No. (%) p value | No. (%) p value | No. (%) p value |
---|---|---|---|
Renal event | 5.2 | 5.7 | 3.8 |
Acute pancreatitis | 0.3$
| 0.4 0.44 | 0.54 |
Hypoglycemia events | 1.3 | 3.3 0.02 | 22.4₭
|