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

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

	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)

CV = cardiovascular; MACE = major adverse cardiovascular event; SAXA = saxagliptin.
*Includes 150 patients who received saxagliptin 20, 40, and 100 mg daily in a dose-ranging trial.
^†Cox proportional hazard ratio (95% CI) for all saxagliptin vs controls.
^‡Includes patients with fatal and nonfatal events; patients with a myocardial infarction and stroke were counted in each category.
^§CV deaths that could not be clearly determined as myocardial infarction or stroke.
^||Investigator-reported and committee-adjudicated CV death rates were identical.
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.

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