Report from the 2nd Cardiovascular Outcome Trial (CVOT) Summit of the Diabetes and Cardiovascular Disease (D&CVD) EASD Study Group

Table 2 CVOTs terminated in 2015 and published in 2016: comparison of results versus placebo

Cardiovascular endpoints	EMPA-REG [4, 5]		LEADER [6]		SUSTAIN-6 [7]
Cardiovascular endpoints	Class	Hazard ratio (95% CI) p value	Class	Hazard ratio (95% CI) p-value	Class	Hazard ratio (95% CI) p-value
Primary composite MACE	CV death, MI, or stroke	0.86 (0.74–0.99) 0.04*	CV death, MI, or stroke	0.87 (0.78–0.97) 0.01	CV death, MI, or stroke	0.74 (0.58–0.95) <0.001/0.02*
Cardiovascular death	Primary end-point	0.62 (0.49–0.77) <0.001	Primary end-point	0.78 (0.66–0.93) 0.007	Primary end-point	0.98 (0.65–1.48) 0.92
Myocardial infarction	Primary end-point	0.87 (0.70–1.09) 0.23	Primary end-point	0.86 (0.73–1.00) 0.046	Primary end-point	0.74 (0.51–1.08) 0.12
Stroke	Primary end-point	1.18 (0.89–1.56) 0.26	Primary end-point	0.86 (0.71–1.06) 0.16	Primary end-point	0.61 (0.38–0.99) 0.04
Hospitalization for unstable angina	Secondary end-point	0.99 (0.74–1.34) 0.97	Extended Primary end-point	0.98 (0.76–1.26) 0.87	Extended Primary end-point	0.82 (0.47–1.44) 0.49
Hospitalization for heart failure	Secondary end-point	0.65 (0.50–0.85) 0.002	Extended Primary end-point	0.87 (0.73–1.05) 0.14	Extended Primary end-point	1.11 (0.77–1.61) 0.57
Primary composite MACE	Event rate (%) active group		Event rate (%) active group		Event rate (%) active group
Primary composite MACE	10.5		13.0		6.6

Non-cardiovascular endpoints	No. (%) p value	No. (%) p value	No. (%) p value
Renal event	5.2	5.7	3.8
Acute pancreatitis	0.3^$	0.4 0.44	0.54
Hypoglycemia events	1.3	3.3 0.02	22.4^₭

* Superiority test; ^$ average across all age ranges; ^₭ Severe hypoglycemia as defined by ADA

ISSN: 1475-2840