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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