Table 3.

Efficacy of oral dapagliflozin 10 mg once daily in in the DECLARE-TIMI 58 cardiovascular outcomes trial [25]

Outcomes	Event rate (%) [per 1000 patient-years]
	DAPA (n = 8582)	PL (n = 8578)	HR vs. PL (95% CI)
Primary efficacy outcomes
CV death or HHFa	4.9 [12.2]	5.8 [14.7]	0.83 (0.73–0.95)*b
MACEa	8.8 [22.6]	9.4 [24.2]	0.93 (0.84–1.03)b
Secondary outcomesc
Renal compositea,d	4.3 [10.8]	5.6 [14.1]	0.76 (0.67–0.87)
Death from any causea	6.2 [15.1]	6.6 [16.4]	0.93 (0.82–1.04)
Other outcomesc
Additional renal compositea,e	1.5 [3.7]	2.8 [7.0]	0.53 (0.43–0.66)
HHF	2.5 [6.2]	3.3 [8.5]	0.73 (0.61–0.88)
MI	4.6 [11.7]	5.1 [13.2]	0.89 (0.77–1.01)
Ischaemic stroke	2.7 [6.9]	2.7 [6.8]	1.01 (0.84–1.21)
Death from CV cause	2.9 [7.0]	2.9 [7.1]	0.98 (0.82–1.17)
Death from non CV cause	2.5 [6.0]	2.8 [6.8]	0.88 (0.73–1.06)

CV cardiovascular, DAPA dapagliflozin, eGFR estimated glomerular filtration rate, HHF hospitalization for heart failure, HR hazard ratio, MACE major adverse cardiovascular event (CV death, MI or ischemic stroke), MI myocardial infarction, PL placebo

*p = 0.005

^aPrespecified outcomes

^bAfter demonstrating the noninferiority of DAPA vs. PL (p < 0.001) for the primary safety outcome of MACE, superiority (two-sided α level of 0.023) of DAPA over PL was demonstrated for the endpoint of CV death or HHF, but not for MACE

^cStatistical analyses are hypothesis generating because of hierarchical testing

^dDefined as ≥ 40% decrease in eGFR to < 60 ml/min/1.73 m², end-stage renal disease, or death from renal or CV cause

^eDefined as ≥ 40% decrease in eGFR to < 60 ml/min/1.73 m², end-stage renal disease, or death from renal cause