Effects of antidiabetic drugs on the incidence of macrovascular complications and mortality in type 2 diabetes mellitus: a new perspective on sodium–glucose co-transporter 2 inhibitors

Figures & data

Table 1. Cardiovascular outcomes in LEADER trial.

Outcome	Liraglutide (N = 4668)	Placebo (N = 4672)	Hazard ratio (95% CI)	p Value
Primary composite endpoint^a	13%	14.9%	0.87 (0.78–0.97)	.01
Expanded composite endpoint^b	20.3%	22.7%	0.88 (0.81–0.96)	.005
Death from CV causes	4.7%	6.0%	0.78 (0.66–0.93)	.007
Death from any cause	8.2%	9.6%	0.85 (0.74–0.97)	.02
MI	6.3%	7.3%	0.86 (0.73–1.00)	.046
Coronary revascularization	8.7%	9.4%	0.91 (0.80–1.04)	.18
Hospitalization for HF	4.7%	5.3%	0.87 (0.73–1.05)	.14
Stroke	3.7%	4.3%	0.86 (0.71–1.06)	.16
Hospitalization for UA	2.6%	2.7%	0.98 (0.76–1.26)	.87

^a Death from CV causes, nonfatal MI, or nonfatal stroke.

^b Death from CV causes, nonfatal MI, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina (UA) or HF.

Table 2. Cardiovascular outcomes in EMPA-REG OUTCOME trial.

Outcome	Empagliflozin (N = 4687)	Placebo (N = 2333)	Hazard ratio (95% CI)	p Value
Primary composite endpoint^a	10.5%	12.1%	0.86 (0.74–0.99)	<.001^c  .04^d
Secondary composite endpoint^b	12.8%	14.3%	0.89 (0.78–1.01)	<.001^c .08^d
Death from CV causes	3.7%	5.9%	0.62 (0.49–0.77)	<.001
Death from any cause	5.7%	8.3%	0.68 (0.57–0.82)	<.001
Hospitalization for HF	2.7%	4.1%	0.65 (0.50–0.85)	.002
MI	4.8%	5.4%	0.87 (0.70–1.09)	.23
Stroke	3.5%	3.0%	1.18 (0.89–1.56)	.26
Hospitalization for UA	2.8%	2.8%	0.99 (0.74–1.34)	.97

^a Death from CV causes, nonfatal MI, or nonfatal stroke.

^b Death from CV causes, nonfatal MI, nonfatal stroke, or hospitalization for UA.

^c Hypothesis was non-inferiority.

^d Hypothesis was superiority.

Table 3. Hazard ratios for the primary outcome considering metformin use in the EMPA-REG OUTCOME trial.

	Patients with event/patients analyzed
Metformin	Empagliflozin	Placebo	Hazard ratio (95% CI)	p Value for interaction
Primary outcome^a
No	146/1228	93/599	0.72 (0.56, 0.94)	.14
Yes	344/3459	189/1734	0.92 (0.77, 1.10)
CV death
No	54/1228	53/599	0.46 (0.32, 0.68)	.07
Yes	118/3459	84/1734	0.71 (0.54, 0.94)

^a Death from CV causes, nonfatal MI, or nonfatal stroke.