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. 2023 May 21;44(31):2966–2977. doi: 10.1093/eurheartj/ehad341

Table 3.

Safety assessments and adverse events of interest

n= Dapagliflozin (n = 30) n= Metolazone (n = 31) P-value
Change in serum urea from baseline, mmol/L
24 h 30 −0.0 (1.4) 29 0.6 (1.5) 0.26
48 h 30 −0.0 (1.9) 29 1.9 (2.7) <0.01
72 h 28 0.1 (3.0) 29 3.7 (3.9) <0.01
96 h 30 −0.0 (3.7) 29 4.4 (5.0) <0.01
Change in eGFR from baseline, mL/min/1.73 m2
24 h 30 −3.0 (−5.8, −0.9) 30 −2.5 (−4.6, 0.3) 0.83
48 h 30 −3.0 (−6.2, −0.1) 30 −5.2 (−9.9, −2.5) 0.02
72 h 28 −3.7 (−7.5, 1.5) 30 −8.9 (−13.6, −3.4) 0.01
96 h 30 −5.9 (−9.4, −0.8) 30 −7.3 (−12.3, −4.9) 0.09
Change in serum creatinine from baseline, µmol/L
24 h 30 8.4 (14.6) 30 6.9 (13.1) 0.67
48 h 30 10.4 (18.7) 30 20.8 (18.9) 0.04
72 h 28 11.2 (28.2) 30 29.3 (26.9) 0.02
96 h 30 16.5 (32.5) 30 29.7 (29.7) 0.11
Impaired renal functiona
Increase in serum creatinine concentration of >26.5 μmol/L 30 14 (47) 30 15 (50) 1.00
eGFR decrease > 50% 30 2 (7) 30 0 0.49
Change in serum potassium from baseline, mmol/L
24 h 29 0.0 (−0.4, 0.2) 28 0.3 (−0.5, −0.1) 0.02
48 h 29 −0.2 (−0.4, 0.0) 28 −0.3 (−0.6, 0.0) 0.29
72 h 28 0.0 (−0.6, 0.4) 29 −0.3 (−0.5, −0.1) 0.30
96 h 29 −0.1 (−0.4, 0.2) 28 −0.3 (−0.4, 0.0) 0.43
Hypokalemia/hyperkalemiaa
Serum potassium ≤3.0 mmol/L 30 1 (3) 30 3 (10) 0.61
Serum potassium ≤3.5 mmol/L 30 15 (50) 30 19 (63) 0.44
Serum potassium ≥5.5 mmol/L 30 1 (3) 30 0 1.00
Change in serum sodium from baseline, mmol/L
24 h 30 1.0 (−1.0, 2.8) 30 −1.0 (−2.0, 0.0) <0.01
48 h 30 1.0 (−1.0, 2.0) 30 −2.0 (−3.0, 0.0) <0.01
72 h 28 1.0 (−2.0, 2.2) 30 −2.0 (−5.0, −1.0) <0.01
96 h 30 0.5 (−1.0, 2.0) 30 −3.0 (−4.8, −1.2) <0.01
Hyponatraemiaa
Serum sodium ≤125 mmol/L 30 1 (3) 30 0 1.00
Serum sodium ≤130 mmol/L 30 5 (17) 30 4 (13) 1.00
AE of special interest— 30 30
Symptoms of hypotension/volume depletion 0 4 (13) 0.11
Urinary tract infections 0 1 (3) 1.00
Genital infections 0 0 n/a
Ketoacidosis 0 0 n/a
Hepatic injury 0 0 n/a
Clinically meaningful escalation of loop diuretic therapyb 0 0 n/a
New utilization/escalation of vasoactive therapy 0 1 (3) 1.00
Renal replacement therapy 0 0 n/a
Worsening HF 0 1 (3) 1.00

AE, adverse event; eGFR, estimated glomerular filtration rate; n/a, not applicable.

At any time point between baseline and 96 h assessment.

Defined as >50% increase in daily dose.