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

Table 2 Time to loss of therapeutic response^a

Measurement	Treatment group, n	Time to LTR, days (95% CI)^b		Hazard ratio (95% CI)^c	P-value^d	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)

^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.

ISSN: 1478-6362