Table 4.
Variable | All patients | BMI <23 kg/m2 | BMI ≥23 to <25 kg/m2 | BMI ≥25 to <28 kg/m2 | BMI ≥28 kg/m2 | |||||
---|---|---|---|---|---|---|---|---|---|---|
Placebo | Ipragliflozin | Placebo | Ipragliflozin | Placebo | Ipragliflozin | Placebo | Ipragliflozin | Placebo | Ipragliflozin | |
SBP | ||||||||||
n | 321 | 508 | 94 | 114 | 74 | 113 | 80 | 144 | 74 | 138 |
Baseline | 128.0 ± 13.61 | 129.3 ± 13.84 | 127.1 ± 14.31 | 125.3 ± 13.89 | 127.6 ± 14.08 | 128.3 ± 13.77 | 127.1 ± 11.87 | 131.1 ± 14.38* | 130.4 ± 13.96 | 131.4 ± 12.56 |
EOT | 127.6 ± 13.16 | 125.2 ± 13.96 | 126.0 ± 13.13 | 122.4 ± 15.13 | 127.4 ± 14.42 | 124.3 ± 11.10 | 128.4 ± 11.52 | 126.2 ± 13.19 | 128.9 ± 13.57 | 127.2 ± 15.45 |
Change | −0.4 ± 13.18 | −4.0 ± 13.19 | −1.4 ± 13.46 | −2.8 ± 14.68 | −0.2 ± 13.91 | −4.0 ± 12.66 | 1.3 ± 12.09 | −4.9 ± 13.23 | −1.5 ± 13.25 | −4.2 ± 12.31 |
Difference (95% CI) | −3.5 (−5.35, −1.62) | −1.9 (−5.66, 1.95) | −4.1 (−8.07, −0.17) | −6.5 (−10.14, −2.95) | −2.0 (−5.73, 1.71) | |||||
P‐value‡ | <0.001 | 0.337 | 0.041 | <0.001 | 0.288 | |||||
DBP | ||||||||||
n | 321 | 508 | 94 | 114 | 74 | 113 | 80 | 144 | 74 | 138 |
Baseline | 76.5 ± 9.81 | 77.4 ± 9.99 | 75.4 ± 9.57 | 75.0 ± 9.66 | 75.0 ± 9.65 | 75.6 ± 10.63 | 77.0 ± 9.84 | 78.5 ± 9.7 | 78.8 ± 9.97 | 79.9 ± 9.36 |
EOT | 76.2 ± 9.95 | 74.8 ± 10.23 | 73.5 ± 8.92 | 72.6 ± 9.89 | 75.3 ± 9.86 | 73.6 ± 9.96 | 76.2 ± 10.36 | 75.6 ± 8.95 | 80.4 ± 9.62 | 76.8 ± 11.51 |
Change | −0.3 ± 9.05 | −2.6 ± 8.76 | −1.9 ± 9.26 | −2.3 ± 8.44 | 0.3 ± 8.92 | −2.0 ± 8.79 | −0.8 ± 8.21 | −2.8 ± 8.11 | 1.6 ± 9.55 | −3.1 ± 9.67 |
Difference (95% CI)† | −2.4 (−3.67, −1.15) | −0.4 (−2.88, 2.07) | −2.7 (−5.36, −0.05) | −2.4 (−4.63, −0.12) | −4.7 (−7.56, −1.88) | |||||
P‐value‡ | <0.001 | 0.750 | 0.046 | 0.039 | 0.001 |
Values are presented as mean ± standard deviation. *Significantly different at P < 0.05. Baseline values were compared between the ipragliflozin and placebo groups within each body mass index (BMI) category using independent‐samples t‐tests. †Adjusted mean difference between groups. ‡Analysis of variance with treatment group and clinical trial as fixed effects. CI, confidence interval; DBP, diastolic blood pressure; EOT, end‐of‐treatment; SBP, systolic blood pressure.