Table 4.
Variable change | Intention-to-treat analysis |
Per-protocol analysis |
||||||
---|---|---|---|---|---|---|---|---|
Dapagliflozin | Placebo | Differencea | P-value | Dapagliflozin | Placebo | Differencea | P-value | |
(n = 32) | (n = 34) | (95% CI) | (n = 29) | (n = 33) | (95% CI) | |||
24 h SBPb | −2.78 ± 5.94 | 0.85 ± 5.40 (n = 33) | −3.63 (−6.44 to −0.82) | 0.012 | −3.07 ± 6.18 | 0.88 ± 5.48 (n = 32) | −3.94 (−6.93 to −0.96) | 0.011 |
24 h DBPb | −0.94 ± 3.98 | 0.06 ± 4.87 (n = 33) | −0.1 (−3.2 to 1.21) | 0.370 | −1.03 ± 4.18 | 0.06 ± 4.94 (n = 32) | −1.1 (−3.46 to 1.260 | 0.356 |
Heart rateb–d | −2.00 ± 5.75 | 1.00 ± 8.50 (n = 33) | −2.1 (−5.64 to 1.43) | 0.184 | −2.0 ± 7.5 | 1.0 ± 8.80 (n = 32) | −2.27 (−6.05 to 1.51) | 0.183 |
Daytime SBPb | −2.47 ± 6.56 | 0.55 ± 6.45 (n = 33) | −3.01 (−6.24 to 0.21) | 0.066 | −2.72 ± 6.85 | 0.56 ± 6.55 (n = 32) | −3.29 (−6.72 to 0.15) | 0.060 |
Daytime DBPb | −1.03 ± 5.18 | 0.24 ± 5.80 (n = 33) | −1.27 (−4.00 to 1.46) | 0.355 | −1.14 ± 5.44 | 0.25 ± 5.90 (n = 32) | −1.39 (−4.30 to 1.53) | 0.345 |
Nocturnal SBPe | −3.47 ± 7.54 | 0.91 ± 6.70 (n = 32) | −4.38 (−7.94 to −0.81) | 0.017 | −3.83 ± 7.84 | 0.94 ± 6.81 (n = 31) | −4.76 (−8.55 to −0.98) | 0.015 |
Nocturnal DBPe | −2.25 ± 5.90 | 0.16 ± 4.14 (n = 32) | −2.41 (−4.95 to 0.14) | 0.063 | −2.48 ± 6.16 | 0.16 ± 4.20 (n = 31) | −2.64 (−5.35 to 0.06) | 0.059 |
Office SBP | −5.28 ± 8.63 | −1.79 ± 7.26 | −3.49 (−7.40 to 0.43) | 0.080 | −5.83 ± 8.89 | −1.85 ± 7.37 | −3.98 (−8.11 to 0.15) | 0.059 |
Office DBP | −2.97 ± 5.62 | −2.24 ± 7.48 | −0.73 (−4.00 to 2.54) | 0.656 | −3.27 ± 5.82 | −2.30 ± 7.58 | −0.97 (−4.39 to 2.44) | 0.577 |
P-values in bold indicate <0.05.
DBP, diastolic blood pressure; SBP, systolic blood pressure.
Absolute mean Difference between groups. All other values expressed in mean ± SD unless stated.
One participant unable to tolerate any ambulatory blood pressure monitoring.
Median ± IQR.
Twenty-four hour heart rate recorded during ambulatory blood pressure monitoring.
eOne further participant unable to tolerate overnight blood pressure monitoring.