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Table 2 Time to loss of therapeutic responsea

From: Continuing efficacy of milnacipran following long-term treatment in fibromyalgia: a randomized trial

Measurement Treatment group, n Time to LTR, days (95% CI)b Hazard ratio
(95% CI)c
P-valued Patients with LTR at end of DB treatment, n(%)
   25th percentile 50th percentile    
Primary analysis PBO, 50 18 (16 to 29) 56 (28 to 85) 0.44 (0.27 to 0.71) <0.001 32 (64)
  MLN, 100 45 (29 to 59) NC    35 (35)
Sensitivity analysis I PBO, 50 18 (16 to 29) 56 (28 to 85) 0.46 (0.29 to 0.74) 0.001 32 (64)
  MLN, 100 36 (29 to 57) NC    37 (37)
Sensitivity analysis II PBO, 50 28 (18 to 63) 85 (60 to NL) 0.35 (0.19 to 0.65) <0.001 21 (42)
  MLN, 100 NC NC    19 (19)
Sensitivity analysis III PBO, 50 29 (17 to NL) NC 0.59 (0.32 to 1.08) 0.08 18 (36)
  MLN, 100 86 (43 to NL) NC    24 (24)
PGIC PBO, 50 22 (15 to 31) 86 (30 to NL) 0.36 (0.20 to 0.63) <0.001 25 (50)
  MLN, 100 NC NC    22 (22)
MAF global fatigue PBO, 50 18 (16 to 68) NC 0.80 (0.46 to 1.38) 0.41 20 (40)
  MLN, 100 30 (26 to 59) NC    36 (36)
SF-36 PCS PBO, 50 15 (15 to 22) 68 (18 to NL) 0.81 (0.50 to 1.30) 0.36 26 (52)
  MLN, 100 23 (15 to 33) 87 (57 to NL)    47 (47)
SF-36 MCS PBO, 50 28 (16 to 46) 57 (29 to NL) 0.74 (0.44 to 1.24) 0.24 23 (46)
  MLN, 100 29 (23 to 60) 90 (85 to NL)    40 (40)
  1. aLoss of therapeutic response was defined as follows: (1) primary analysis: <30% reduction in Visual Analogue Scale (VAS) pain score from pre-milnacipran exposure or worsening of fibromyalgia requiring alternative treatment; (2) sensitivity analysis I: <30% reduction in VAS pain score from pre-milnacipran exposure or withdrawal from the study for any reason; (3) sensitivity analysis II: <30% reduction in VAS pain score from pre-milnacipran exposure; or (4) sensitivity analysis III: worsening of fibromyalgia requiring alternative treatment. DB = double-blind; LTR = loss of therapeutic response; MAF = Multidimensional Assessment of Fatigue; MCS = Mental Component Summary; MLN = milnacipran; NC = not calculable (no patients in quartile); NL = no limit; PBO = placebo; PCS = Physical Component Summary; PGIC = Patient Global Impression of Change; SF-36 = Short Form-36 Health Survey. bQuartiles (that is, 25th percentile, 50th percentile) based on Kaplan-Meier estimates. cHazard ratio of milnacipran versus placebo based on Cox proportional hazards regression model with treatment group as an explanatory variable. dP-values based on logrank comparison between milnacipran and placebo.