Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study

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.

An evidence-based review of pregabalin for the treatment of fibromyalgia

“…Dizziness and somnolence were the most commonly reported AEs and were also the most common AEs leading to discontinuation. The safety profile of pregabalin was similar in adolescents and adults, although the incidence of somnolence was lower in adolescents and incidences of nausea and fatigue were higher (data not shown) [52]. AE duration was reported for a limited number of patients in two studies [42,43].…”

“…Eleven clinical studies were identified as randomized, double-blind, placebo-controlled, studies [42][43][44][45][46][47][48][49][50][51][52]. Table 1 shows a summary of the studies (see also Table 1 of the Supplemental Online Material for more details of each study).…”

“…Five studies [43,[45][46][47]52] had open-label extensions with the main objective of examining long-term safety and tolerability [52][53][54]. Pooled data from three studies showed that for up to 1 year of treatment at doses up to 600 mg/day, 77.9% of patients reported an AE and 12.4% discontinued treatment owing to an AE [53].…”

“…The most common AEs were nasopharyngitis, somnolence, dizziness, constipation, and weight gain. In the 6-month open-label extension in adolescents, 71.4% experienced an AE, 4.8% experienced a SAE, and 3.2% discontinued treatment owing to AEs [52]. The most frequent AEs were weight gain, dizziness, fatigue, and headache.…”

Fibromyalgia: Treating Pain in the Juvenile Patient

“…Arnold et al recently examined the safety and efficacy of pregabalin in adolescents with fibromyalgia [30]. The study was a randomized, double-blind, placebo-controlled trial with a 6-month open-label extension.…”