Skip to main content

Table 5 Mean changes in vital signs

From: Preliminary experience using milnacipran in patients with juvenile fibromyalgia: lessons from a clinical trial program

 

Randomized withdrawal study

Extension study

 

Open-label period

Double-blind period

  

Vital signs, mean (SD)

Milnacipran n = 116

Placebo n = 6

Milnacipran n = 14

Milnacipran n = 57

Systolic BP, mm Hg

    

Baselinea

113.3 (9.7)

117.3 (7.9)

115.0 (7.7)

112.5 (8.7)

Change

4.1 (8.9)

−1.2 (6.8)

−1.4 (10.9)

2.5 (10.7)

Diastolic BP, mm Hg

    

Baselinea

69.5 (7.8)

76.3 (9.3)

70.8 (10.4)

68.1 (8.7)

Change

5.2 (8.6)

−7.0 (8.3)

−0.1 (9.9)

4.2 (8.8)

Heart rate, bpm

    

Baselinea

81.0 (11.1)

100.5 (17.9)

87.1 (17.5)

81.6 (10.8)

Change

10.0 (14.4)

−6.8 (16.0)

0.1 (18.6)

4.3 (11.1)

Body weight, kg

    

Baselinea

69.4 (17.6)

71.9 (20.7)

64.7 (14.2)

68.9 (18.1)

Change

−0.8 (2.0)

1.9 (1.7)

−0.1 (1.9)

−0.5 (3.9)

  1. aFor the open-label period of the randomized withdrawal study and for the extension study, baseline was defined as the last available assessment before the first dose of open-label treatment in the randomized withdrawal study. For the double-blind period, baseline was defined as the last available assessment prior to the first dose of double-blind treatment
  2. BP = blood pressure