Outcomes of the two CV safety NI studies that claim superiority
| Placebo (N=2333) Number (%) | Incident rate Number of events/1000 patient-years | Epaglifozin (N=4687) Number (%) | Incident rate Number of events/1000 patient-years | HR (95% CI) | p Value | |
|---|---|---|---|---|---|---|
| Primary composite outcome | 282 (12.1) | 43.9 | 490 (10.5) | 37.4 | 0.86 (0.74 to 0.99) | p<0.001 NI p=0.04 superiority |
| Non-fatal MI | 121 (5.2) | 18.5 | 213 (4.5) | 16 | 0.87 (0.70 to 1.09) | 0.22 |
| Non-fatal CVA | 60 (2.6) | 9.1 | 150 (3.2) | 11.2 | 1.24 (0.92 to 1.67) | 0.16 |
| CV death | 137 (5.9) | 20.2 | 172 (3.7) | 12.4 | 0.62 (0.49 to 0.77) | <0.001 |
| Placebo (N=4672) Number (%) | Incident rate Number of events/ 100 patient-years | Liraglutide (N=4668) Number (%) | Incident rate Number of events/ 100 patient-years | HR (95% CI) | p Value (superiority) | |
|---|---|---|---|---|---|---|
| Primary composite outcome | 694 (14.9) | 3.9 | 608 (13) | 3.4 | 0.87 (0.78 to 0.97) | 0.01 |
| Non-fatal MI | 317 (6.8) | 1.8 | 281 (6) | 1.6 | 0.88 (0.75 to 1.03) | 0.11 |
| Non-fatal CVA | 177 (3.8) | 1.0 | 159 (3.4) | 0.9 | 0.89 (0.72 to 1.11) | 0.30 |
| CV death | 278 (6) | 1.6 | 219 (4.7) | 1.2 | 0.78 (0.66 to 0.93) | 0.007 |
EMPA-REG outcome10—epagliflozin N=7020, mean duration of observation 3.1 years, NI margin 1.3, sample size 691 events required for NI with 90% power assuming HR 1.0. Duration of trial until reached adjudicated outcome of at least 691 patients. Primary outcome is the time to event of a composite of death from CV causes (CV death), non-fatal MI or non-fatal CVA.
LEADER11—liraglutide N=9340, mean duration of follow-up 3.8 years, NI margin 1.3, sample size 611 events required for a NI with 90% power assuming a HR 1.0. Duration of the trial would be a follow-up of minimum of 42 weeks and maximum of 60 months receiving intervention and 30 days of follow-up afterward. The data safety monitoring board could terminate for adverse events or clear evidence of benefit in the liraglutide arm (significance level determined p<0.001). Primary outcome is the time to event of a composite of death from CV causes (CV death), non-fatal MI or non-fatal CVA.
CV, cardiovascular; CVA, stroke; NI, non-inferiority; MI, myocardial infarction.