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Table 2 CV Event Rate (Incidence [SD]) per 1000 Patient-Years [47]

From: Saxagliptin for the treatment of type 2 diabetes mellitus: assessing cardiovascular data

  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)
  1. CV = cardiovascular; MACE = major adverse cardiovascular event; MedDRA = Medical Dictionary for Regulatory Activities.
  2. *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."
  3. Custom MACE is a composite endpoint of CV death, MI and stroke using MedDRA preferred terms indicative of MACE suggested by the FDA.
  4. §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.