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Table 1 Retrospective Analysis of CV Events With Saxagliptin Versus Comparators in Phase II/III Clinical Trials [23]

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

  Number of Patients (%)  
  SAXA
2.5 mg
(n = 937)
SAXA
5 mg
(n = 1269)
SAXA
10 mg
(n = 1000)
All SAXA*
(n = 3356)
Controls
(n = 1251)
Hazard Ratio
(95% CI)
Investigator-reported MACE 6 (0.6) 6 (0.5) 11 (1.1) 23 (0.7) 18 (1.4) 0.44
(0.2-0.82)
Adjudicated MACE 6 (0.6) 7 (0.6) 9 (0.9) 22 (0.7) 18 (1.4) 0.42
(0.23-0.80)
Myocardial infarction
Stroke
Other CV deaths§
2 (0.2)
4 (0.4)
0 (0)
4 (0.3)
4 (0.3)
0 (0)
2 (0.2)
3 (0.3)
4 (0.4)
8 (0.2)
11 (0.3)
4 (0.1)
8 (0.6)
5 (0.4)
6 (0.5)
 
All deaths 3 (0.3) 3 (0.2) 4 (0.4) 10 (0.3) 12 (1.0)  
CV deaths|| 1 (0.1) 2 (0.2) 4 (0.4) 7 (0.2) 10 (0.8)  
  1. CV = cardiovascular; MACE = major adverse cardiovascular event; SAXA = saxagliptin.
  2. *Includes 150 patients who received saxagliptin 20, 40, and 100 mg daily in a dose-ranging trial.
  3. Cox proportional hazard ratio (95% CI) for all saxagliptin vs controls.
  4. Includes patients with fatal and nonfatal events; patients with a myocardial infarction and stroke were counted in each category.
  5. §CV deaths that could not be clearly determined as myocardial infarction or stroke.
  6. ||Investigator-reported and committee-adjudicated CV death rates were identical.
  7. Table reprinted from Postgraduate Medicine, (3)122, Frederich R, Alexander JH, Fiedorek FT et al. A Systematic Assessment of Cardiovascular Outcomes in the Saxagliptin Drug Development Program for Type 2 Diabetes, page 20. Copyright 2010, with permission from JTE Multimedia.