Table 4 Incidence and incidence rates of primary, secondary, and tertiary endpoints
Linagliptin (n= 3319) | Active comparators* (n= 943) | Placebo (n= 977) | Total comparators (n= 1920) | |||||
|---|---|---|---|---|---|---|---|---|
Incidence n (%) | Incidence rate (per 1000 years) | Incidence n (%) | Incidence rate (per 1000 years) | Incidence n (%) | Incidence rate (per 1000 years) | Incidence n (%) | Incidence rate (per 1000 years) | |
Primary endpoints: | ||||||||
CV death, stroke, MI, or UAP with hospitalization | 11 (0.3) | 5.3 | 20 (2.1) | 21.2 | 3 (0.3) | 7.0 | 23 (1.2) | 16.8 |
Secondary endpoints: | ||||||||
CV death, stroke, or MI | 10 (0.3) | 4.8 | 18 (1.9) | 19.1 | 2 (0.2) | 4.7 | 20 (1.0) | 14.6 |
All major CV events | 26 (0.8) | 12.6 | 26 (2.8) | 27.6 | 6 (0.6) | 14.1 | 32 (1.7) | 23.4 |
FDA-custom MACE | 9 (0.3) | 4.3 | 16 (1.7) | 16.9 | 3 (0.3) | 7.0 | 19 (1.0) | 13.9 |
Tertiary endpoints: | ||||||||
CV death | 2 (0.06) | 1.0 | 2 (0.2) | 2.1 | 0 | 0 | 2 (0.1) | 1.5 |
MI | 6 (0.2) | 2.9 | 6 (0.6) | 6.3 | 1 (0.1) | 2.3 | 7 (0.4) | 5.1 |
Stroke | 2 (0.06) | 1.0 | 10 (1.1) | 10.6 | 1 (0.1) | 2.3 | 11 (0.6) | 8.0 |
TIA | 1 (0.03) | 0.5 | 3 (0.3) | 3.2 | 1 (0.1) | 2.3 | 4 (0.2) | 2.9 |
UAP with hospitalization | 1 (0.03) | 0.5 | 2 (0.2) | 2.1 | 1 (0.1) | 2.3 | 3 (0.2) | 2.2 |
UAP without hospitalization | 1 (0.03) | 0.5 | 1 (0.1) | 1.1 | 0 | 0 | 1 (0.05) | 0.7 |
SAP | 13 (0.4) | 6.3 | 5 (0.5) | 5.3 | 3 (0.3) | 7.0 | 8 (0.4) | 5.8 |
Total mortality | 4 (0.1) | 1.9 | 3 (0.3) | 3.2 | 0 | 0 | 3 (0.2) | 2.2 |