| |
Linagliptin (n = 5847)
|
Total comparators (n = 3612)
|
|---|
| |
Incidence n (%)
|
Incidence rate (per 1000 years)
|
Incidence n (%)
|
Incidence rate (per 1000 years)
|
|---|
|
Primary end points
| | | | |
|
CV death, stroke, MI, or UAP with hospitalization
|
60 (1.0)
|
13.4
|
62 (1.7)
|
18.9
|
|
Secondary end points
| | | | |
|
CV death, stroke, or MI
|
42 (0.7)
|
9.3
|
46 (1.3)
|
14.0
|
|
All major CV events
|
96 (1.6)
|
21.5
|
95 (2.6)
|
29.1
|
|
FDA-custom MACE
|
39 (0.7)
|
8.7
|
45 (1.3)
|
13.7
|
|
Tertiary end points
| | | | |
|
CV death
|
11 (0.2)
|
2.4
|
8 (0.2)
|
2.4
|
|
Non-fatal MI
|
23 (0.4)
|
5.1
|
20 (0.6)
|
6.1
|
|
Non-fatal stroke
|
9 (0.2)
|
2.0
|
19 (0.5)
|
5.8
|
|
TIA
|
1 (0.02)
|
0.2
|
8 (0.2)
|
2.4
|
|
UAP with hospitalization
|
22 (0.4)
|
4.9
|
16 (0.4)
|
4.8
|
|
Hospitalization for CHF*
|
12 (0.6)
|
8.8
|
9 (0.7)
|
8.4
|
|
Total mortality
|
18 (0.3)
|
4.0
|
16 (0.4)
|
4.8
|
-
CHF, congestive heart failure; CV, cardiovascular; FDA, Food and Drug Administration; MACE, major adverse CV events; MI, myocardial infarction; TIA, transient ischemic attack; UAP, unstable angina pectoris.
- *Includes data only from trials with prospective independent adjudication of hospitalization for CHF (n = 3314).
