Table 2.
Summary of changes from baseline in blood pressure and fasting plasma lipids at weeks 26 and 52 (LOCF)
| Week 26 | Week 52 | ||||
|---|---|---|---|---|---|
| Parameter | PBO (n = 115) | CANA 100 mg (n = 113) | CANA 300 mg (n = 114) | CANA 100 mg (n = 113) | CANA 300 mg (n = 114) |
| Systolic BP, n | 114 | 113 | 112 | 113 | 112 |
| Mean ± s.d. baseline, mmHg | 128.2 ± 12.3 | 126.4 ± 12.3 | 126.7 ± 12.0 | 126.4 ± 12.3 | 126.7 ± 12.0 |
| LS mean ± s.e. change | −1.2 ± 1.0 | −5.3 ± 1.0 | −4.7 ± 1.0 | −3.4 ± 1.1 | −3.7 ± 1.1 |
| Difference vs. PBO (95% CI) | −4.1 (−6.9, −1.3) | −3.5 (−6.3, −0.6) | |||
| Diastolic BP, n | 114 | 113 | 112 | 113 | 112 |
| Mean ± s.d. baseline, mmHg | 77.1 ± 8.2 | 75.6 ± 7.8 | 76.6 ± 8.3 | 75.6 ± 7.8 | 76.6 ± 8.3 |
| LS mean ± s.e. change | −0.9 ± 0.7 | −3.3 ± 0.7 | −3.5 ± 0.7 | −2.5 ± 0.7 | −2.7 ± 0.7 |
| Difference vs. PBO (95% CI) | −2.4 (−4.2, −0.5) | −2.6 (−4.4, −0.7) | |||
| Triglycerides, n | 105 | 108 | 109 | 110 | 110 |
| Mean ± s.d. baseline, mmol/l(mg/dl) | 1.6 ± 1.0 (143.9 ± 86.0) | 1.7 ± 1.1 (146.7 ± 97.6) | 1.6 ± 1.1 (143.8 ± 100.1) | 1.7 ± 1.1 (145.7 ± 97.0) | 1.7 ± 1.2 (146.6 ± 103.9) |
| LS mean ± s.e. change, mmol/l(mg/dl) | 0.10 ± 0.08 (8.6 ± 7.0) | −0.06 ± 0.08 (−5.3 ± 6.9) | −0.16 ± 0.08 (−13.9 ± 6.9) | −0.06 ± 0.11 (−5.4 ± 9.5) | −0.05 ± 0.11 (−4.6 ± 9.5) |
| Median (IQR) percent change | 6.3 (−19.2, 37.8) | −2.4 (−23.5, 27.3) | −3.1 (−23.4, 10.9) | −1.6 (−21.3, 28.7) | −8.3 (−29.4, 16.3) |
| LS mean ± s.e. percent change | 15.3 ± 4.1 | 3.1 ± 4.1 | −1.7 ± 4.1 | 4.7 ± 4.0 | −0.6 ± 4.0 |
| Difference vs. PBO (95% CI) | −12.1 (−23.3, −1.0) | −17.0 (−28.1, −5.8) | |||
| LDL-C, n | 105 | 107 | 109 | 110 | 110 |
| Mean ± s.d. baseline, mmol/l(mg/dl) | 2.5 ± 0.9 (96.9 ± 34.5) | 2.4 ± 0.9 (92.1 ± 33.5) | 2.3 ± 0.8 (89.0 ± 31.1) | 2.4 ± 0.9 (92.7 ± 33.4) | 2.3 ± 0.9 (90.2 ± 33.5) |
| LS mean ± s.e. change, mmol/l(mg/dl) | −0.10 ± 0.06 (−3.9 ± 2.5) | 0.08 ± 0.06 (3.3 ± 2.5) | 0.19 ± 0.06 (7.2 ± 2.5) | 0.16 ± 0.07 (6.1 ± 2.8) | 0.20 ± 0.07 (7.8 ± 2.9) |
| Median (IQR) percent change | −3.0 (−18.5, 14.1) | 2.7 (−7.6, 20.6) | 6.8 (−7.5, 23.5) | 4.7 (−9.1, 22.7) | 5.4 (−7.4, 29.5) |
| LS mean ± s.e. percent change | −0.4 ± 2.6 | 7.1 ± 2.5 | 11.3 ± 2.5 | 10.9 ± 3.2 | 14.3 ± 3.2 |
| Difference vs. PBO (95% CI) | 7.5 (0.6, 14.4) | 11.7 (4.8, 18.6) | |||
| HDL-C, n | 105 | 107 | 109 | 110 | 110 |
| Mean ± s.d. baseline, mmol/l(mg/dl) | 1.3 ± 0.3 (49.1 ± 11.9) | 1.3 ± 0.3 (49.2 ± 12.9) | 1.4 ± 0.3 (52.1 ± 12.4) | 1.3 ± 0.3 (49.3 ± 12.7) | 1.3 ± 0.3 (52.0 ± 12.4) |
| LS mean ± s.e. change, mmol/l(mg/dl) | 0.02 ± 0.02 (0.7 ± 0.7) | 0.08 ± 0.02 (3.2 ± 0.7) | 0.10 ± 0.02 (3.8 ± 0.7) | 0.08 ± 0.02 (3.0 ± 0.8) | 0.13 ± 0.02 (5.1 ± 0.8) |
| Median (IQR) percent change | 1.3 (−5.9, 11.0) | 5.1 (−2.3, 17.8) | 8.0 (−1.8, 17.3) | 6.8 (−3.2, 16.3) | 9.3 (−1.7, 20.7) |
| LS mean ± s.e. percent change | 2.4 ± 1.4 | 7.2 ± 1.4 | 8.9 ± 1.3 | 7.0 ± 1.6 | 11.4 ± 1.6 |
| Difference vs. PBO (95% CI) | 4.8 (1.1, 8.5) | 6.5 (2.8, 10.2) | |||
| LDL-C/HDL-C, n | 105 | 107 | 109 | 110 | 110 |
| Mean ± s.d. baseline, mol/mol | 2.1 ± 0.9 | 2.0 ± 0.8 | 1.8 ± 0.7 | 2.0 ± 0.8 | 1.8 ± 0.8 |
| LS mean ± s.e. change | −0.11 ± 0.06 | −0.02 ± 0.06 | 0.00 ± 0.06 | 0.05 ± 0.06 | −0.03 ± 0.06 |
| Median (IQR) percent change | −4.4 (−21.5, 15.6) | −3.6 (−16.0, 8.1) | 1.2 (−13.3, 16.7) | −0.4 (−17.7, 20.4) | −1.4 (−15.5, 18.3) |
| LS mean ± s.e. percent change | −0.7 ± 2.8 | 1.8 ± 2.8 | 3.5 ± 2.8 | 5.5 ± 3.2 | 4.4 ± 3.3 |
| Difference vs. PBO (95% CI) | 2.4 (−5.2, 10.1) | 4.1 (−3.6, 11.8) | |||
| Non–HDL-C, n | 105 | 107 | 109 | 110 | 110 |
| Mean ± s.d. baseline, mmol/l(mg/dl) | 3.2 ± 1.0 (125.2 ± 39.8) | 3.2 ± 1.0 (121.7 ± 40.4) | 3.0 ± 1.0 (117.2 ± 37.3) | 3.2 ± 1.0 (122.3 ± 40.5) | 3.1 ± 1.0 (118.6 ± 39.9) |
| LS mean ± s.e. change, mmol/l(mg/dl) | −0.05 ± 0.08 (−1.9 ± 3.0) | 0.05 ± 0.08 (1.8 ± 3.0) | 0.13 ± 0.08 (5.2 ± 3.0) | 0.14 ± 0.08 (5.3 ± 3.1) | 0.24 ± 0.08 (9.1 ± 3.2) |
| Median (IQR) percent change | 0.3 (−14.3, 12.3) | 1.2 (−8.0, 11.6) | 3.4 (−7.6, 16.1) | 2.6 (−8.3, 17.9) | 3.8 (−7.6, 21.9) |
| LS mean ± s.e. percent change | 1.4 ± 2.4 | 3.3 ± 2.3 | 6.2 ± 2.3 | 6.8 ± 2.6 | 9.0 ± 2.6 |
| Difference vs. PBO (95% CI) | 1.9 (−4.6, 8.3) | 4.8 (−1.6, 11.2) |
LOCF, last observation carried forward; PBO, placebo; CANA, canagliflozin; BP, blood pressure, s.d., standard deviation; LS, least squares; s.e., standard error; CI, confidence interval; IQR, interquartile range; LDL-C, low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol; NS, not significant.
*
p < 0.01 versus PBO.
†
p < 0.025 versus PBO.
‡
Statistical comparison versus PBO not performed (not pre-specified).
§
p = NS versus PBO based on Hochberg's testing approach.
‖
p < 0.001 versus PBO.