Table 2. Changes in carotid ultrasonography parameters.
Endpoint | Time point | Febuxostat | Control | Group difference (95% CI) | P Value | ||
---|---|---|---|---|---|---|---|
Number | Mean (SD) | Number | Mean (SD) | ||||
Mean CCA-IMT, mm | Baseline | 239 | 0.825 (0.173) | 241 | 0.832 (0.175) | −0.007 (−0.039 to 0.024) | 0.65 |
12 months | 207 | 0.826 (0.185) | 210 | 0.841 (0.188) | −0.015 (−0.051 to 0.021) | 0.42 | |
24 months | 208 | 0.832 (0.182) | 196 | 0.848 (0.176) | −0.016 (−0.051 to 0.019) | 0.37 | |
Delta from baseline, mm | 12 months | 207 | 0.003 (0.099) | 208 | 0.012 (0.090) | −0.009 (−0.027 to 0.010) | 0.35 |
24 months | 207 | 0.006 (0.087) | 193 | 0.008 (0.090) | −0.002 (−0.020 to 0.015) | 0.81 | |
Percentage change from baseline | 12 months | 207 | 0.011 (0.115) | 208 | 0.021 (0.110) | −0.010 (−0.032 to 0.011) | 0.35 |
24 months | 207 | 0.015 (0.104) | 193 | 0.018 (0.109) | −0.003 (−0.024 to 0.018) | 0.81 | |
Mean bulb-IMT, mm | Baseline | 225 | 1.068 (0.342) | 222 | 1.085 (0.364) | −0.017 (−0.083 to 0.048) | 0.61 |
12 months | 194 | 1.062 (0.325) | 196 | 1.089 (0.354) | −0.027 (−0.094 to 0.041) | 0.44 | |
24 months | 190 | 1.131 (0.380) | 181 | 1.136 (0.384) | −0.005 (−0.083 to 0.073) | 0.89 | |
Delta from baseline, mm | 12 months | 185 | −0.001 (0.263) | 179 | 0.009 (0.258) | −0.010 (−0.064 to 0.044) | 0.71 |
24 months | 178 | 0.065 (0.272) | 169 | 0.030 (0.279) | 0.036 (−0.023 to 0.094) | 0.23 | |
Percentage change from baseline | 12 months | 185 | 0.044 (0.230) | 179 | 0.050 (0.244) | −0.006 (−0.055 to 0.043) | 0.81 |
24 months | 178 | 0.104 (0.272) | 169 | 0.064 (0.230) | 0.041 (−0.013 to 0.094) | 0.13 | |
Mean ICA-IMT, mm | Baseline | 145 | 0.789 (0.297) | 155 | 0.773 (0.328) | 0.016 (−0.055 to 0.087) | 0.66 |
12 months | 154 | 0.840 (0.348) | 139 | 0.822 (0.371) | 0.017 (−0.066 to 0.101) | 0.68 | |
24 months | 134 | 0.846 (0.364) | 126 | 0.848 (0.346) | −0.001 (−0.088 to 0.085) | 0.98 | |
Delta from baseline, mm | 12 months | 111 | 0.024 (0.233) | 111 | 0.024 (0.345) | −0.0002 (−0.078 to 0.078) | >0.99 |
24 months | 102 | 0071 (0.268) | 101 | 0.115 (0.276) | −0.044 (−0.119 to 0.031) | 0.25 | |
Percentage change from baseline | 12 months | 111 | 0.070 (0.273) | 111 | 0.083 (0.315) | −0.013 (−0.091 to 0.065) | 0.75 |
24 months | 102 | 0.136 (0.354) | 101 | 0.179 (0.350) | −0.043 (−0.141 to 0.054) | 0.38 | |
Maximum CCA-IMT, mm | Baseline | 239 | 1.040 (0.230) | 241 | 1.056 (0.235) | −0.016 (−0.057 to 0.026) | 0.46 |
12 months | 207 | 1.045 (0.254) | 210 | 1.071 (0.264) | −0.025 (−0.075 to 0.024) | 0.32 | |
24 months | 208 | 1.044 (0.244) | 197 | 1.070 (0.250) | −0.026 (−0.074 to 0.022) | 0.29 | |
Delta from baseline, mm | 12 months | 207 | 0.013 (0.159) | 208 | 0.016 (0.151) | −0.003 (−0.033 to 0.027) | 0.84 |
24 months | 207 | 0.003 (0.140) | 194 | 0.008 (0.146) | −0.006 (−0.034 to 0.023) | 0.70 | |
Percentage change from baseline | 12 months | 207 | 0.020 (0.145) | 208 | 0.025 (0.135) | −0.005 (−0.032 to 0.022) | 0.74 |
24 months | 207 | 0.015 (0.132) | 194 | 0.019 (0.133) | −0.004 (−0.030 to 0.022) | 0.76 | |
Maximum bulb-IMT, mm | Baseline | 225 | 1.533 (0.518) | 222 | 1.578 (0.604) | −0.045 (−0.150 to 0.060) | 0.40 |
12 months | 194 | 1.591 (0.521) | 196 | 1.633 (0.583) | −0.042 (−0.152 to 0.068) | 0.45 | |
24 months | 190 | 1.702 (0.628) | 181 | 1.683 (0.621) | 0.019 (−0.109 to 0.147) | 0.77 | |
Delta from baseline, mm | 12 months | 185 | 0.077 (0.458) | 179 | 0.068 (0.476) | 0.009 (−0.088 to 0.105) | 0.86 |
24 months | 178 | 0.168 (0.470) | 169 | 0.083 (0.485) | 0.085 (−0.016 to 0.186) | 0.098 | |
Percentage change from baseline | 12 months | 185 | 0.119 (0.312) | 179 | 0.107 (0.312) | 0.012 (−0.052 to 0.076) | 0.71 |
24 months | 178 | 0.171 (0.324) | 169 | 0.112 (0.299) | 0.059 (−0.007 to 0.125) | 0.079 | |
Maximum ICA-IMT, mm | Baseline | 145 | 1.058 (0.380) | 155 | 1.050 (0.457) | 0.008 (−0.087 to 0.104) | 0.86 |
12 months | 154 | 1.197 (0.521) | 139 | 1.167 (0.559) | 0.031 (−0.094 to 0.155) | 0.63 | |
24 months | 134 | 1.156 (0.526) | 126 | 1.177 (0.551) | −0.021 (−0.153 to 0.111) | 0.75 | |
Delta from baseline, mm | 12 months | 111 | 0.080 (0.426) | 111 | 0.074 (0.480) | 0.006 (−0.114 to 0.126) | 0.92 |
24 months | 102 | 0.098 (0.396) | 101 | 0.187 (0.478) | −0.088 (−0.210 to 0.033) | 0.15 | |
Percentage change from baseline | 12 months | 111 | 0.128 (0.407) | 111 | 0.134 (0.392) | −0.006 (−0.112 to 0.100) | 0.91 |
24 months | 102 | 0.140 (0.371) | 101 | 0.215 (0.447) | −0.075 (−0.189 to 0.039) | 0.20 | |
Plaque area, mm2 | Baseline | 203 | 7.176 (5.027) | 194 | 6.874 (6.627) | 0.302 (−0.863 to 1.467) | 0.61 |
12 months | 85 | 7.971 (5.206) | 91 | 8.248 (7.419) | −0.277 (−2.175 to 1.621) | 0.77 | |
24 months | 79 | 8.885 (5.665) | 89 | 7.551 (7.109) | 1.334 (−0.615 to 3.283) | 0.18 | |
Delta from baseline, mm | 12 months | 85 | 1.153 (4.695) | 91 | 1.271 (6.235) | −0.117 (−1.753 to 1.519) | 0.89 |
24 months | 79 | 1.133 (5.200) | 89 | 0.954 (4.653) | 0.179 (−1.332 to 1.691) | 0.82 | |
Percentage change from baseline | 12 months | 85 | 0.526 (1.281) | 91 | 0.586 (1.702) | −0.060 (−0.506 to 0.387) | 0.79 |
24 months | 79 | 0.526 (1.812) | 89 | 0.338 (0.996) | 0.188 (−0.267 to 0.642) | 0.42 | |
Plaque grayscale median | Baseline | 203 | 46.732 (25.870) | 194 | 46.339 (25.232) | 0.393 (−4.650 to 5.436) | 0.88 |
12 months | 85 | 54.648 (24.738) | 91 | 54.503 (25.045) | 0.145 (−7.264 to 7.554) | 0.97 | |
24 months | 79 | 54.145 (26.906) | 89 | 52.451 (19.897) | 1.694 (−5.599 to 8.987) | 0.65 | |
Delta from baseline, mm | 12 months | 85 | 3.332 (26.636) | 91 | 9.810 (26.446) | −6.478 (−14.381 to 1.425) | 0.11 |
24 months | 79 | 2.608 (30.699) | 89 | 8.838 (21.664) | −6.231 (−14.432 to 1.970) | 0.14 | |
Percentage change from baseline | 12 months | 85 | 0.331 (1.326) | 91 | 0.443 (0.759) | −0.112 (−0.437 to 0.214) | 0.50 |
24 months | 79 | 0.226 (0.722) | 89 | 0.486 (0.994) | −0.260 (−0.523 to 0.002) | 0.052 |
Abbreviations: CCA, common carotid artery; CI, confidence interval; ICA, internal carotid artery; IMT, intima-media thickness; SD, standard deviation