Table 3.

Number of patients with adverse events by treatment periods

Adverse Event Type	Dapagliflozin	Eplerenone	Dapagliflozin-Eplerenone	Wash-out
Any adverse event	12	17	13	1
Serious adverse event	0	1 (2.2)	1 (2.2)	0
Death	0	1 (2.2)	1 (2.2)	0
Adverse events
Hyperkalemia	0	8 (17.4)	2 (4.3)*	0
Hypotension	0	1 (2.2)	3 (6.5)	0
Acute renal insufficiency	0	0	1 (2.2)	0
Urinary tract infection	1 (2.2)	1 (2.2)	0	0
Asymptomatic bacteriuria	9 (19.6)	2 (4.3)	4 (8.7)	0
Hypoglycemia	0	0	0	0
Dyspnea	1 (2.2)	0	0	0
Mild abdominal pain	1 (2.2)	0	0	0
Constipation	0	1 (2.2)	0	1 (2.2)
Toothache	0	1 (2.2)	0	0
Renal colic	0	1 (2.2)	0	0
Lipothymia	0	0	1 (2.2)	0

Among 32 patients with type 2 diabetes, 7 and 2 hyperkalemia adverse events were recorded during eplerenone and dapagliflozin-eplerenone treatment, respectively. Urinary tract infections were reported in one patient with type 2 diabetes during treatment with dapagliflozin and in one patient without diabetes during treatment with eplerenone.

^*P value across treatment groups, 0.00328.