Table 3. Serum apolipoproteins and lipid-related parameters at base and week 52 and percent changes at 52 weeks by study group.
Parameters | Combination |
Fenofibrate |
Ezetimibe |
||||
---|---|---|---|---|---|---|---|
n | Mean ± SD | n | Mean ± SD | n | Mean ± SD | ||
Apo A-I (mg/dL) | Baseline | 107 | 137 ± 18 | 52 | 134 ± 18 | 51 | 137 ± 19 |
Week 52 | 69 | 144 ± 19 | 36 | 141 ± 21 | 38 | 139 ± 29 | |
%Change | 69 | 7.7 ± 9.1* | 36 | 8.5 ± 13.1* | 38 | 0.9 ± 11.3 | |
p = 0.702 | p = 0.001 | ||||||
Apo A-II (mg/dL) | Baseline | 107 | 32 ± 5 | 52 | 30 ± 4 | 51 | 31 ± 4 |
Week 52 | 69 | 42 ± 9 | 36 | 39 ± 10 | 38 | 31 ± 5 | |
%Change | 69 | 33.7 ± 25.5* | 36 | 30.1 ± 29.6* | 38 | −0.5 ± 9.3 | |
p = 0.512 | p < 0.001 | ||||||
Apo B (mg/dL) | Baseline | 107 | 130 ± 17 | 52 | 133 ± 20 | 51 | 134 ± 19 |
Week 52 | 69 | 89 ± 19 | 36 | 105 ± 22 | 38 | 113 ± 13 | |
%Change | 69 | −31.5 ± 13.1* | 36 | −21.7 ± 14.4* | 38 | −15.2 ± 8.7* | |
p < 0.001 | p < 0.001 | ||||||
Apo B-48 (µg/mL) | Baselinea | 105 | 11.4 ± 7.7 | 52 | 11.0 ± 7.5 | 50 | 10.0 ± 7.0 |
Week 52 | 67 | 5.1 ± 3.7 | 35 | 6.8 ± 4.8 | 38 | 8.8 ± 5.1 | |
%Change | 67 | −33.7 ± 56.4* | 35 | −17.9 ± 98.9 | 38 | 5.7 ± 60.4 | |
p = 0.305 | p = 0.001 | ||||||
Apo C-II (mg/dL) | Baseline | 107 | 7.0 ± 1.6 | 52 | 6.8 ± 1.8 | 51 | 7.1 ± 1.9 |
Week 52 | 69 | 5.3 ± 1.7 | 36 | 5.8 ± 2.0 | 38 | 6.7 ± 1.5 | |
%Change | 69 | −20.9 ± 18.9* | 36 | −15.7 ± 23.3* | 38 | −0.2 ± 18.4 | |
p = 0.220 | p < 0.001 | ||||||
Apo C-III (mg/dL) | Baseline | 107 | 14.1 ± 3.2 | 52 | 13.9 ± 3.6 | 51 | 14.4 ± 3.7 |
Week 52 | 69 | 9.7 ± 3.5 | 36 | 10.6 ± 3.3 | 38 | 13.8 ± 3.9 | |
%Change | 69 | −29.3 ± 18.2* | 36 | −21.8 ± 24.7* | 38 | −2.2 ± 25.3 | |
p = 0.081 | p < 0.001 | ||||||
Apo E (mg/dL) | Baseline | 107 | 5.2 ± 1.1 | 52 | 5.1 ± 1.2 | 51 | 5.2 ± 1.4 |
Week 52 | 69 | 3.8 ± 0.9 | 36 | 4.1 ± 0.8 | 38 | 4.7 ± 1.5 | |
%Change | 69 | −24.1 ± 15.4* | 36 | −18.3 ± 21.0* | 38 | −6.9 ± 18.2* | |
p = 0.111 | p < 0.001 | ||||||
RemL-C (mg/dL) | Baselinea | 105 | 19.7 ± 11.0 | 52 | 20.2 ± 14.9 | 50 | 20.8 ± 21.5 |
Week 52 | 69 | 8.3 ± 5.1 | 36 | 12.1 ± 7.2 | 38 | 16.3 ± 6.1 | |
%Change | 69 | −46.1 ± 37.3* | 36 | −17.4 ± 93.1 | 38 | −3.2 ± 38.8 | |
p = 0.026 | p < 0.001 | ||||||
LDL particle size | Baselinea | 105 | 25.9 ± 0.6 | 52 | 25.9 ± 0.8 | 49 | 25.8 ± 0.6 |
(nm) | Week 52 | 69 | 26.7 ± 0.6 | 36 | 26.6 ± 0.6 | 38 | 25.9 ± 0.6 |
%Change | 69 | 3.4 ± 2.9* | 36 | 3.4 ± 2.8* | 38 | 0.5 ± 2.2 | |
p = 0.996 | p < 0.001 | ||||||
HDL particle size | Baselinea | 105 | 10.5 ± 0.3 | 52 | 10.5 ± 0.3 | 49 | 10.5 ± 0.3 |
(nm) | Week 52 | 69 | 10.4 ± 0.2 | 36 | 10.4 ± 0.2 | 38 | 10.5 ± 0.3 |
%Change | 69 | −0.9 ± 1.8* | 36 | −0.7 ± 1.5* | 38 | 0.4 ± 1.7 | |
p = 0.712 | p < 0.001 | ||||||
Phospholipid | Baselinea | 95 | 349 ± 282 | 47 | 320 ± 217 | 45 | 313 ± 449 |
hydroperoxide | Week 52 | 69 | 294 ± 236 | 36 | 261 ± 224 | 37 | 264 ± 226 |
(nmol/L) | %Change | 60 | −0.9 ± 48.1 | 31 | −11.1 ± 34.1 | 33 | 9.0 ± 49.9 |
p = 0.294 | p = 0.352 | ||||||
hsCRP (mg/dL) | Baselinea | 105 | 0.16 ± 0.21 | 52 | 0.15 ± 0.20 | 50 | 0.19 ± 0.23 |
Week 52 | 69 | 0.13 ± 0.18 | 36 | 0.09 ± 0.13 | 38 | 0.19 ± 0.22 | |
%Change | 69 | 30.3 ± 264.0 | 36 | −3.0 ± 78.4 | 38 | 123.9 ± 406.3 | |
p = 0.462 | p = 0.152 |
Mean values at baseline were based on the average of multiple measurements during the pretreatment period (week −4 to week 0)
p values represent the comparison of the percent changes between the combination group and the specified group by two-sample t-test (two-sided).
A single measurement at week 0
p < 0.05 for the within-group comparison by one sample t-test.
Apo, apolipoprotein; RemL-C, remnant-like lipoprotein cholesterol; LDL, low-density lipoprotein; HDL, high-density lipoprotein; hsCRP high-sensitivity assay for C-reactive protein