Long-term tolerability and maintenance of therapeutic response to sodium oxybate in an open-label extension study in patients with fibromyalgia

Table 4 Responder analyses at open-label study endpoint in patients with FM syndrome

Parameter	Sodium oxybate final dose
	4.5 g	6 g	7.5 g	9 g	Total^a
Pain VAS	number = 165	number = 187	number = 114	number = 81	number = 551
≥30% reduction, number (%)	112 (67.9)	140 (74.9)	67 (58.8)	59 (72.8)	379 (68.8)
≥50% reduction, number (%)	88 (53.3)	110 (58.8)	47 (41.2)	47 (58.0)	292 (53.0)
FIQ total score	number = 168	number = 187	number = 114	number = 81	number = 554
≥30% reduction, number (%)	113 (67.3)	142 (75.9)	67 (58.8)	61 (75.3)	386 (69.7)
≥50% reduction, number (%)	81 (48.2)	110 (58.8)	51 (44.7)	47 (58.0)	290 (52.3)
PGI-c	number = 167	number = 187	number = 114	number = 81	number = 553
’Very much better’ or ‘much better,’ number (%)	103 (61.7)	117 (62.6)	59 (51.8)	53 (65.4)	334 (60.4)
CGI-c	number = 168	number = 187	number = 114	number = 81	number = 554
‘Very much improved’ or ‘much improved,’ number (%)	106 (63.1)	120 (64.2)	66 (57.9)	56 (69.1)	350 (63.2)
FM Syndrome Composite Response	number = 167	number = 187	number = 114	number = 81	number = 553
Responders, number (%)^b	79 (47.3)	104 (55.6)	48 (42.1)	46 (56.8)	278 (50.3)
FM Pain Composite Response	number = 167	number = 187	number = 114	number = 81	number = 553
Responders, number (%)^c	85 (50.9)	107 (57.2)	50 (43.9)	47 (58.0)	290 (52.4)

For Pain VAS, baseline was the average of all available daily averages during the last week of the baseline period in the double-blind studies. For post-baseline assessments, the average of all daily averages during the prior week was used. Study endpoint was defined as the last available data (study completion or early discontinuation). ^aIf the final dose was not among those indicated, the patient was summarized only for the ‘Total’ group; ^bFibromyalgia Syndrome Composite Responders were patients who achieved PGI-c response of ‘very much better’ or ‘much better,’ ≥30% reduction in pain VAS, and ≥30% reduction in FIQ total score at study endpoint compared with baseline of the double-blind study; ^cFibromyalgia Pain Composite Responders (at endpoint) were patients who achieved PGI-c response of ‘very much better’ or ‘much better’ and who had ≥30% reduction in pain VAS at study endpoint compared with baseline of the double-blind study. CGI-c, Clinical Global Impression of Change; FIQ, Fibromyalgia Impact Questionnaire; FM, fibromyalgia syndrome; PGI-c, Patient Global Impression of Change; VAS, visual analog scale.

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