Table 2.

Summary of pain, global, and physical function responder rates at 3 months in milnacipran phase 3 clinical studies in fibromyalgia^a.

		Study 1 [Mease et al. 2009b]			Study 2 [Clauw et al. 2008a]			Study 3 [Arnold et al. 2009a]		Study 4 [Branco et al. 2010]
		Placebo	Milnacipran 100 mg/day	Milnacipran 200 mg/day	Placebo	Milnacipran 100 mg/day	Milnacipran 200 mg/day	Placebo	Milnacipran 100 mg/day	Placebo	Milnacipran 200 mg/day
Painb	LOCF	35%	40%	42%	29%	37%**	40%***	31%	45%***	30%	39%**
	OC	39%	56%**	60%***	38%	52%**	55%***	37%	53%***	33%	46%***
Globalc	LOCF	30%	38%	39%*	25%	35%**	38%***	26%	42%***	21%	33%***
	OC	37%	53%**	55%***	32%	48%***	51%***	33%	52%***	23%	41%***
Physical functiond	LOCF	34%	38%	40%	25%	32%*	28%	31%	40%***	NA	NA
	OC	38%	51%*	50%*	30%	41%**	35%	37%	47%**	NA	NA

^*p<0.05;

^**p≤0.01;

^***p≤ 0.001, versus placebo.

^aFrom published literature and/or data on file.

^bProportion of patients achieving ≥30% improvement from baseline in PED 24-hour recall pain.

^cProportion of patients achieving Patient Global Impression of Change response of ‘very much improved’ or ‘much improved’.

^dProportion of patients achieving a ≥6-point improvement from baseline in Short Form-36 Physical Component Summary score.

LOCF, last observation carried forward; OC, observed cases; NA, not applicable to Study 4; PED, patient experience diary.