| |
All Saxagliptin*
(n = 3356)
|
Controls
(n = 1251)
|
|---|
|
Standard MedDRA query MACE†
|
28.4 (2.9)
|
31.9 (5.0)
|
|
Acute CV events
|
10.7 (1.8)
|
17.6 (3.7)
|
|
Custom MACE‡
|
6.2 (1.3)
|
13.1 (3.2)
|
|
Primary MACE§
|
6.2 (1.3)
|
13.9 (3.3)
|
- CV = cardiovascular; MACE = major adverse cardiovascular event; MedDRA = Medical Dictionary for Regulatory Activities.
- *Includes 150 patients who received saxagliptin 20, 40, and 100 mg daily in a dose-ranging trial. †Standard MedDRA query MACE is a composite endpoint of CV death and all standard MedDRA query preferred terms for "myocardial infarction" and "central nervous system hemorrhages and cerebrovascular accidents."
- ‡Custom MACE is a composite endpoint of CV death, MI and stroke using MedDRA preferred terms indicative of MACE suggested by the FDA.
- §Primary MACE includes adverse events of myocardial infarction, stroke, or CV death developed by the sponsor. In practice, custom MACE differed from primary MACE only by a single subject which the investigator updated to an event of anterior MI. Such an update was allowed by the sponsor rules.
