Abstract
BackgroundFibromyalgia (FM) is a common pain condition characterized by widespread musculoskeletal pain and tenderness. Pregabalin is an approved treatment for adults in the United States, but there are no approved treatments for adolescents with FM.MethodsThis was a 15-week, randomized, double-blind, placebo-controlled study and 6-month open-label safety trial of flexible-dose pregabalin (75–450 mg/day) for the treatment of adolescents (12–17 years) with FM. Primary outcome was change in mean pain score at endpoint (scored from 0–10, with 24-h recall). Secondary outcomes included global assessments and measures of pain, sleep, and FM impact.ResultsA total of 107 subjects were randomized to treatment (54 pregabalin, 53 placebo) and 80 completed the study (44 pregabalin, 36 placebo). Improvement in mean pain score at endpoint with pregabalin versus placebo was not statistically significant, treatment difference (95 % CI), −0.66 (−1.51, 0.18), P = 0.121. There were significant improvements with pregabalin versus placebo in secondary outcomes of change in pain score by week (P < 0.05 for 10 of 15 weeks); change in pain score at week 15 (1-week recall), treatment difference (95 % CI), −0.87 (−1.68, −0.05), P = 0.037; and patient global impression of change, 53.1 % versus 29.5 % very much or much improved (P = 0.013). Trends toward improvement with pregabalin in other secondary outcomes measuring pain, sleep, and FM impact were not significant. Safety was consistent with the known profile of pregabalin in adults with FM.ConclusionPregabalin did not significantly improve the mean pain score in adolescents with FM. There were significant improvements in secondary outcomes measuring pain and impression of change.Trial registrationsNCT01020474; NCT01020526.
Highlights
Fibromyalgia (FM) is a common pain condition characterized by widespread musculoskeletal pain and tenderness
Subjects who participated in the above study were given the option to receive pregabalin in a 6-month open-label safety trial, with subjects who experienced a serious adverse event (AE) during the double-blind study excluded
Double-blind study Patient population A total of 107 subjects were randomized to treatment (54 pregabalin, 53 placebo) and 80 completed the study (44 pregabalin, 36 placebo) (Fig. 1)
Summary
Fibromyalgia (FM) is a common pain condition characterized by widespread musculoskeletal pain and tenderness. FM can affect both adults and adolescents, where it is associated with significant impairment of social, emotional, and physical functioning [3, 4]. The pathophysiology of FM in both adults and adolescents is unknown; it is likely related to abnormalities in central nervous system pain and sensory processing [5]. FM in adolescents is associated with significant impairment in physical functioning, lower perceived health status, and higher health care utilization compared with age-matched healthy peers [7, 8]. Estimates of the prevalence of FM in adolescents vary markedly, from 1.0 % up to 6.2 % [9,10,11,12,13]. Recognition and diagnosis of FM in adolescents is often challenging, which can cause frustration and anxiety in patients and their parents [7]
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