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.