Table 4.
Summary of changes from baseline in fasting plasma lipids at Week 26 (LOCF)*
| |
Patients <65 y |
Patients ≥65 y |
||||
|---|---|---|---|---|---|---|
| PBO | CANA 100 mg | CANA 300 mg | PBO | CANA 100 mg | CANA 300 mg | |
| Triglycerides, n |
446 |
614 |
610 |
118 |
139 |
131 |
| Mean ± SD baseline, mmol/L |
2.2 ± 1.4 |
2.1 ± 1.5 |
2.1 ± 1.5 |
1.8 ± 0.8 |
1.9 ± 1.1 |
1.7 ± 0.9 |
| LS mean ± SE change |
0.01 ± 0.05 |
-0.10 ± 0.04 |
-0.23 ± 0.04 |
-0.05 ± 0.05 |
-0.14 ± 0.05 |
-0.16 ± 0.05 |
| Median (IQR) percent change |
-1.6 |
-6.0 |
-9.3 |
-3.2 |
-7.4 |
-9.2 |
| (-22.1, 28.8) |
(-26.4, 24.4) |
(-28.6, 19.8) |
(-20.4, 16.3) |
(-21.9, 10.6) |
(-25.8, 10.2) |
|
| LS mean ± SE percent change |
9.1 ± 2.2 |
3.7 ± 2.0 |
0.6 ± 2.0 |
2.6 ± 3.0 |
-2.4 ± 2.8 |
-2.5 ± 2.9 |
| Difference versus PBO (95% CI) |
|
-5.4 (-11.1, 0.3) |
-8.5 (-14.2, -2.8) |
|
-5.0 (-13.0, 3.1) |
-5.1 (-13.3, 3.1) |
| LDL-C, n |
444 |
609 |
601 |
118 |
137 |
129 |
| Mean ± SD baseline, mmol/L |
2.9 ± 1.0 |
2.8 ± 0.9 |
2.7 ± 0.9 |
2.7 ± 1.0 |
2.6 ± 0.9 |
2.7 ± 1.0 |
| LS mean ± SE change |
-0.05 ± 0.03 |
0.06 ± 0.03 |
0.17 ± 0.03 |
-0.07 ± 0.06 |
0.04 ± 0.05 |
0.07 ± 0.06 |
| Median (IQR) percent change |
-2.3 |
2.0 |
6.5 |
-1.5 |
1.9 |
2.0 |
| (-16.9, 11.3) |
(-10.7, 19.4) |
(-7.8, 23.9) |
(-9.8, 12.2) |
(-7.1, 15.5) |
(-10.5, 17.9) |
|
| LS mean ± SE percent change |
1.5 ± 1.4 |
6.3 ± 1.2 |
9.8 ± 1.2 |
0.7 ± 2.1 |
3.5 ± 1.9 |
6.8 ± 2.0 |
| Difference versus PBO (95% CI) |
|
4.8 (1.2, 8.4) |
8.3 (4.7, 11.9) |
|
2.7 (-2.9, 8.4) |
6.1 (0.4, 11.8) |
| HDL-C, n |
446 |
612 |
606 |
118 |
138 |
129 |
| Mean ± SD baseline, mmol/L |
1.2 ± 0.3 |
1.2 ± 0.3 |
1.2 ± 0.3 |
1.2 ± 0.3 |
1.3 ± 0.3 |
1.3 ± 0.3 |
| LS mean ± SE change |
0.03 ± 0.01 |
0.09 ± 0.01 |
0.10 ± 0.01 |
0.03 ± 0.02 |
0.12 ± 0.02 |
0.12 ± 0.02 |
| Median (IQR) percent change |
3.2 |
7.3 |
9.5 |
3.9 |
9.2 |
9.7 |
| (-6.0, 13.6) |
(-2.6, 19.6) |
(-0.7, 20.0) |
(-4.7, 11.8) |
(0.0, 17.6) |
(-0.8, 21.2) |
|
| LS mean ± SE percent change |
4.0 ± 0.8 |
9.2 ± 0.7 |
10.2 ± 0.7 |
3.6 ± 1.4 |
9.8 ± 1.3 |
10.8 ± 1.4 |
| Difference versus PBO (95% CI) |
|
5.2 (3.1, 7.3) |
6.1 (4.1, 8.2) |
|
6.2 (2.4, 9.9) |
7.2 (3.4, 11.0) |
| LDL-C/HDL-C, n |
444 |
609 |
601 |
118 |
137 |
129 |
| Mean ± SD baseline, mol/mol |
2.6 ± 1.1 |
2.5 ± 1.0 |
2.4 ± 0.9 |
2.3 ± 1.0 |
2.2 ± 0.9 |
2.2 ± 0.8 |
| LS mean ± SE change |
-0.13 ± 0.03 |
-0.12 ± 0.03 |
-0.07 ± 0.03 |
-0.10 ± 0.05 |
-0.15 ± 0.05 |
-0.11 ± 0.05 |
| Median (IQR) percent change |
-6.8 |
-5.4 |
-1.5 |
-4.4 |
-3.3 |
-7.3 |
| (-19.3, 9.3) |
(-19.0, 10.9) |
(-16.3, 14.1) |
(-19.8, 12.8) |
(-17.4, 7.8) |
(-21.9, 11.8) |
|
| LS mean ± SE percent change |
-0.5 ± 1.4 |
-0.7 ± 1.2 |
1.3 ± 1.2 |
-1.4 ± 2.3 |
-4.2 ± 2.2 |
-1.2 ± 2.3 |
| Difference versus PBO (95% CI) |
|
-0.2 (-3.8, 3.4) |
1.8 (-1.8, 5.4) |
|
-2.8 (-9.1, 3.4) |
0.2 (-6.2, 6.5) |
| Non–HDL-C, n |
446 |
609 |
602 |
117 |
138 |
127 |
| Mean ± SD baseline, mmol/L |
3.9 ± 1.1 |
3.8 ± 1.1 |
3.6 ± 1.0 |
3.5 ± 1.2 |
3.5 ± 1.1 |
3.5 ± 1.1 |
| LS mean ± SE change |
-0.04 ± 0.04 |
0.00 ± 0.03 |
0.10 ± 0.03 |
-0.09 ± 0.07 |
-0.02 ± 0.06 |
-0.02 ± 0.06 |
| Median (IQR) percent change |
-2.3 |
-0.7 |
2.4 |
-2.6 |
0.0 |
0.0 |
| (-13.6, 9.7) |
(-10.2, 13.1) |
(-8.6, 14.9) |
(-10.6, 9.5) |
(-6.3, 11.5) |
(-12.6, 13.5) |
|
| LS mean ± SE percent change |
1.1 ± 1.0 |
2.6 ± 0.9 |
4.7 ± 0.9 |
-0.5 ± 1.8 |
0.8 ± 1.7 |
2.8 ± 1.8 |
| Difference versus PBO (95% CI) | 1.4 (-1.3, 4.1) | 3.6 (0.8, 6.3) | 1.3 (-3.6, 6.2) | 3.3 (-1.7, 8.3) | ||
LOCF, last observation carried forward; PBO, placebo; CANA, canagliflozin; SD, standard deviation; LS, least squares; SE, standard error; IQR, interquartile range; CI, confidence interval; LDL-C, low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol.
*All fasting plasma lipids parameters are reported for regardless of rescue medication.