Table 2.
Biological, Adverse Effects and Hemodynamic Parameters
Measures | Placebo (n=17) | Febuxostat (n=17) | Febuxostat‐Rasburicase (n=17) | P Value | |||
---|---|---|---|---|---|---|---|
ANOVA | Placebo vs Febuxostat | Placebo vs Febuxostat‐Rasburicase | Febuxostat vs Febuxostat‐Rasburicase | ||||
Biological | |||||||
Uric acid, μmol/L | 321.2±13.6 | 126.7±10.1 | 18.2±1.7 | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
Sodium, mmol/La | 142.0 (141.0; 142.0) | 142.0 (141.0; 142.0) | 141.0 (141.0; 142.3) | 1.0 | ··· | ··· | ··· |
Potassium, mmol/L | 3.9±0.1 | 3.8±0.1 | 3.8±0.1 | 0.5 | ··· | ··· | ··· |
Chloride, mmol/L | 101.1±0.2 | 100.6±0.3 | 101.2±0.4 | 0.3 | ··· | ··· | ··· |
Urea, mmol/L | 4.6±0.2 | 4.8±0.2 | 4.4±0.2 | 0.04 | 0.2 | 0.9 | 0.1 |
Creatinine, μmol/La | 79.6 (70.7; 88.4) | 88.4 (79.6; 88.4) | 88.4 (79.6; 88.4) | 0.015 | 0.09 | 0.04 | 1.0 |
Urea/creatinine ratio | 56.6±2.7 | 56.7±2.2 | 52.0±2.8 | 0.045 | 1.0 | 0.2 | 0.2 |
Platelets, ×10³/mm³ | 230.5±11.9 | 231.7±11.2 | 228.1±12.7 | 0.9 | ··· | ··· | ··· |
CRP, nmol/La | 4.8 (4.8; 11.9) | 5.9 (4.8; 9.5) | 4.8 (4.8; 18.1) | 0.5 | ··· | ··· | ··· |
Adverse effects, n (%) | |||||||
Any | 6 (35.3) | 12 (70.6) | 15 (88.2) | 0.004 | 0.12 | 0.003 | 0.6 |
Diarrhea | 0 (0.0) | 4 (23.5) | 3 (17.6) | 0.1 | ··· | ··· | ··· |
Abdominal pain | 1 (5.9) | 5 (29.4) | 4 (23.5) | 0.2 | ··· | ··· | ··· |
Headache | 3 (17.6) | 4 (23.5) | 8 (47.1) | 0.1 | ··· | ··· | ··· |
Nausea | 0 (0.0) | 3 (17.6) | 3 (17.6) | 0.2 | ··· | ··· | ··· |
Fatigue | 0 (0.0) | 2 (11.8) | 3 (17.6) | 0.2 | ··· | ··· | ··· |
Hot spell | 1 (5.9) | 3 (17.6) | 5 (29.4) | 0.2 | ··· | ··· | ··· |
Other | 1 (5.9) | 0 (0.0) | 1 (5.9) | 0.4 | ··· | ··· | ··· |
Hemodynamic parameters | |||||||
PWV, m/s | 5.3±0.1 | 5.5±0.1 | 5.3±0.2 | 0.2 | ··· | ··· | ··· |
AIx, % | 0.6±2.6 | 0.4±1.8 | 1.5±1.8 | 0.9 | ··· | ··· | ··· |
AIx@75, % | −7.0±2.4 | −6.2±1.8 | −6.1±1.9 | 0.9 | ··· | ··· | ··· |
Systolic BP, mm Hg | 109.4±2.5 | 111.2±1.6 | 106.5±2.1 | 0.023 | 0.9 | 0.4 | 0.01 |
Diastolic BP, mm Hg | 69.2±1.9 | 69.6±1.5 | 67.2±1.7 | 0.5 | ··· | ··· | ··· |
HR, /min | 61.7±1.3 | 63.6±1.0 | 62.9±1.6 | 0.3 | ··· | ··· | ··· |
SpO2, % | 97.7±0.5 | 97.7±0.3 | 97.5±0.4 | 0.4 | ··· | ··· | ··· |
Data are given as mean±SEM or median (quartile 1; quartile 3). AIx and AIx@75 indicate augmentation index and heart rate‐corrected augmentation index; BP, blood pressure; CRP, C‐reactive protein; HR, heart rate; PWV, pulse wave velocity; SpO2, saturation of peripheral oxygen.
Not normally distributed.