Table 5.
Summary of changes from baseline in blood pressure and fasting plasma lipids at week 52 (LOCF)
| PBO | CANA 100 mg | CANA 300 mg | |
|---|---|---|---|
| Systolic BP, n | 150 | 156 | 154 |
| Mean ± SD baseline (mmHg) | 130.1 ± 13.7 | 130.4 ± 13.5 | 130.8 ± 12.8 |
| LS mean ± SE change | 0.1 ± 1.0 | –3.7 ± 1.0 | –2.9 ± 1.0 |
| Difference vs. PBO (95% CI) | –3.7 (–6.2, –1.3) | –3.0 (–5.5, –0.5) | |
| Diastolic BP, n | 150 | 156 | 154 |
| Mean ± SD baseline (mmHg) | 79.0 ± 8.3 | 78.2 ± 8.3 | 78.9 ± 8.1 |
| LS mean ± SE change | –0.7 ± 0.6 | –2.2 ± 0.6 | –1.7 ± 0.6 |
| Difference vs. PBO (95% CI) | –1.6 (–3.2, 0.1) | –1.1 (–2.7, 0.5) | |
| Triglycerides, n | 134 | 145 | 144 |
| Mean ± SD baseline (mmol/l) | 2.2 ± 1.5 | 2.1 ± 1.3 | 2.3 ± 1.5 |
| LS mean ± SE change | 0.03 ± 0.10 | 0.04 ± 0.10 | –0.14 ± 0.10 |
| Median (IQR) per cent change | –1.2 (–18.7, 22.7) | 5.3 (–19.0, 24.8) | 0.2 (–27.6, 23.7) |
| LS mean ± SE per cent change | 4.7 ± 4.6 | 8.5 ± 4.6 | 6.7 ± 4.5 |
| Difference vs. PBO (95% CI) | 3.8 (–7.8, 15.4) | 2.0 (–9.6, 13.6) | |
| LDL-C, n | 134 | 145 | 144 |
| Mean ± SD baseline (mmol/l) | 2.8 ± 1.0 | 2.7 ± 1.1 | 2.6 ± 0.9 |
| LS mean ± SE change | 0.05 ± 0.06 | 0.01 ± 0.06 | 0.22 ± 0.06 |
| Median (IQR) per cent change | 0.2 (–12.9, 12.3) | 3.6 (–11.2, 17.9) | 6.7 (–5.0, 27.6) |
| LS mean ± SE per cent change | 5.4 ± 2.8 | 4.8 ± 2.8 | 13.3 ± 2.8 |
| Difference vs. PBO (95% CI) | –0.6 (–7.7, 6.5) | 7.9 (0.8, 15.0) | |
| HDL-C, n | 135 | 145 | 144 |
| Mean ± SD baseline (mmol/l) | 1.2 ± 0.3 | 1.2 ± 0.3 | 1.1 ± 0.3 |
| LS mean ± SE change | 0.03 ± 0.02 | 0.07 ± 0.01 | 0.09 ± 0.01 |
| Median (IQR) per cent change | 0.0 (–7.0, 10.3) | 5.4 (–2.2, 14.3) | 7.3 (–2.0, 16.0) |
| LS mean ± SE per cent change | 3.3 ± 1.3 | 6.6 ± 1.3 | 8.2 ± 1.3 |
| Difference vs. PBO (95% CI) | 3.2 (–0.1, 6.5) | 4.9 (1.6, 8.2) | |
| LDL-C/HDL-C, n | 134 | 145 | 144 |
| Mean ± SD baseline (mol/mol) | 2.4 ± 0.9 | 2.4 ± 1.1 | 2.4 ± 0.9 |
| LS mean ± SE change | 0.00 ± 0.06 | –0.15 ± 0.06 | 0.03 ± 0.05 |
| Median (IQR) per cent change | 0.3 (–17.0, 14.3) | –3.3 (–17.7, 13.3) | 1.5 (–12.2, 17.8) |
| LS mean ± SE per cent change | 3.7 ± 2.7 | –0.3 ± 2.7 | 5.1 ± 2.6 |
| Difference vs. PBO (95% CI) | –4.0 (–10.8, 2.8) | 1.4 (–5.4, 8.2) | |
| Non–HDL-C, n | 133 | 145 | 144 |
| Mean ± SD baseline (mmol/l) | 3.8 ± 1.2 | 3.6 ± 1.3 | 3.7 ± 1.1 |
| LS mean ± SE change | 0.07 ± 0.07 | –0.02 ± 0.07 | 0.14 ± 0.07 |
| Median (IQR) per cent change | –0.2 (–9.8, 10.6) | 0.8 (–9.2, 14.7) | 4.9 (–10.3, 22.0) |
| LS mean ± SE per cent change | 3.9 ± 2.1 | 2.5 ± 2.1 | 7.5 ± 2.1 |
| Difference vs. PBO (95% CI) | –1.5 (–6.9, 3.9) | 3.6 (–1.8, 9.0) |
LOCF, last observation carried forward; PBO, placebo; CANA, canagliflozin; BP, blood pressure; SD, standard deviation; LS, least squares; SE, standard error; CI, confidence interval; IQR, interquartile range; LDL-C, low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol.