Table 2

Changes in daytime and nighttime BP

Placebo10 mg empagliflozin25 mg empagliflozin
SBP
 Daytime mean SBP (ABPM) at week 12, mmHg136.44 (0.74)131.85 (0.73)130.99 (0.70)
  Change from baseline, mmHg0.53 (0.51)−3.42 (0.51)−4.25 (0.51)
  Difference vs. placebo−3.94 (0.73)−4.78 (0.72)
  95% CI(−5.37, −2.52)(−6.20, −3.36)
  P<0.001<0.001
 Nighttime mean SBP (ABPM) at week 12, mmHg123.60 (0.77)121.29 (0.83)120.83 (0.79)
  Change from baseline, mmHg0.41 (0.57)−2.10 (0.57)−2.50 (0.57)
  Difference vs. placebo−2.50 (0.81)−2.90 (0.81)
  95% CI(−4.09, −0.91)(−4.48, −1.32)
  P0.002<0.001
DBP
 Daytime mean DBP (ABPM) at week 12, mmHg78.94 (0.49)77.09 (0.50)76.35 (0.49)
  Change from baseline, mmHg0.32 (0.31)−1.24 (0.31)−1.67 (0.31)
  Difference vs. placebo−1.56 (0.44)−1.98 (0.44)
  95% CI(−2.42, −0.69)(−2.84, −1.12)
  P<0.001<0.001
 Nighttime mean DBP (ABPM) at week 12, mmHg68.54 (0.47)67.86 (0.54)67.30 (0.51)
  Change from baseline, mmHg0.31 (0.35)−0.65 (0.35)−0.84 (0.35)
  Difference vs. placebo−0.95 (0.50)−1.15 (0.50)
  95% CI(−1.93, 0.03)(−2.12, −0.18)
  P0.0570.021
Subgroup analyses
 Mean 24-h SBP*
  Patients with BP ≥130/80 mmHg (ABPM) at baseline, n150141153
   Change from baseline in mean 24-h SBP, mmHg−1.30 (0.69)−5.47 (0.71)−6.33 (0.69)
   Difference vs. placebo−4.18 (1.00)−5.04 (0.98)
   95% CI(−6.13, −2.22)(−6.96, −3.12)
   P<0.001<0.001
  Patients with BP <130/80 mmHg (ABPM) at baseline, n§121135123
   Change from baseline in mean 24-h SBP, mmHg2.44 (0.77)−0.25 (0.73)−0.22 (0.77)
   Difference vs. placebo−2.69 (1.07)−2.66 (1.09)
   95% CI(−4.78, −0.60)(−4.80, −0.53)
   P0.0120.015
 Mean 24-h DBP
  Patients with BP ≥130/80 mmHg (ABPM) at baseline, n150141153
   Change from baseline in mean 24-h DBP, mmHg−0.72 (0.40)−2.57 (0.41)−2.56 (0.39)
   Difference vs. placebo−1.85 (0.57)−1.84 (0.56)
   95% CI(−2.96, −0.74)(−2.93, −0.75)
   P0.0010.001
  Patients with BP <130/80 mmHg (ABPM) at baseline, n§121135123
   Change from baseline in mean 24-h DBP, mmHg1.52 (0.44)0.49 (0.42)0.22 (0.44)
   Difference vs. placebo−1.02 (0.61)−1.30 (0.62)
   95% CI(−2.22, 0.17)(−2.51, −0.08)
   P0.0920.036
  • Data are adjusted mean (SE) based on ANCOVA in FAS (n = 271 for placebo, n = 276 for 10 mg empagliflozin, and n = 276 for 25 mg empagliflozin) with LOCF-H imputation.

  • * Treatment-by-baseline mean 24-h BP category interaction: P = 0.2602.

  • Treatment-by-baseline mean 24-h BP category interaction: P = 0.6003.

  • 24-h mean SBP ≥130 mmHg or 24-h mean DBP ≥80 mmHg.

  • § 24-h SBP <130 mmHg and mean 24-h DBP <80 mmHg.