Table 6

Mean changes and incidence of potentially significant vital sign parameters, safety population

Group; mean ± SD
Vital sign parameterPlacebo, n = 185Levomilnacipran ER, 40 mg/day, n = 186Levomilnacipran ER, 80 mg/day, n = 188
Supine SBP, mm Hg
 Baseline116.3 ± 10.9117.3 ± 11.2116.7 ± 11.2
 Change at end of double-blind period0.1 ± 10.03.8 ± 9.72.9 ± 9.0
Supine DBP, mm Hg
 Baseline74.2 ± 7.573.5 ± 8.373.5 ± 8.1
 Change at end of double-blind period0.4 ± 7.84.3 ± 6.83.8 ± 7.0
Supine pulse rate, beats/min
 Baseline70.4 ± 9.770.8 ± 10.070.7 ± 9.3
 Change at end of double-blind period−0.5 ± 9.35.4 ± 9.66.0 ± 10.2
Body weight, kg
 Baseline81.7 ± 17.881.2 ± 17.181.7 ± 17.6
 Change at end of double-blind period0.1 ± 1.8−0.5 ± 1.9−0.4 ± 1.8
Orthostatic hypotension,* no. (%)17 (9.3)23 (12.4)§17 (9.1)
Potentially significant change criteria, no. (%)
 Supine SBP (≤ 90 mm Hg and decrease ≥ 20 mm Hg)01 (0.5)0
 Supine DBP (≥ 105 mm Hg and increase ≥ 15 mm Hg)01 (0.5)0
 Supine pulse rate (≤ 50 beats/min and decrease ≥ 15 beats/min)1 (0.5)00
 Body weight, kg (≥ 7% increase)01 (0.5)2 (1.1)
 Body weight, kg (≥ 7% decrease)01 (0.5)1 (0.5)
  • DBP = diastolic blood pressure; ER = extended-release; SBP = systolic blood pressure; SD = standard deviation.

  • * Reduction in SBP ≥ 20 mm Hg or in DBP ≥ 10 mm Hg changing from supine to standing position.

  • Unless otherwise indicated.

  • n = 183.

  • § n = 185.

  • n = 186.