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 Totala
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.

Spaeth et al.

Spaeth et al. Arthritis Research & Therapy 2013 15:R185   doi:10.1186/ar4375

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