Duloxetine May Be Ineffective in Juvenile Primary Fibromyalgia
Study participants were randomly assigned to receive duloxetine or placebo for a period of 13 weeks.
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Duloxetine may not be effective in treating juvenile primary fibromyalgia syndrome (JPFS), according to study results to be presented at the World Congress on Pain 2018, held September 12-16 in Boston, Massachusetts.
The study included 184 participants age 13 to 17 with JPFS and a rating ≥4 on the Brief Pain Inventory (BPI) average pain severity randomly assigned to receive duloxetine (n=91) at a starting dose of 30 mg with a target dose of 60 mg, as tolerated, or placebo (n=93) for a period of 13 weeks. The study's primary end point was the mean change in BPI average pain severity rating from baseline to week 13.
Secondary end points included BPI-Modified Short Form: Adolescent Version severity and interference, treatment response (30% and 50% reductions in BPI average pain severity), and scores on the Pediatric Pain Questionnaire, Clinical Global Impression of Severity: Overall and Mental Illness scales, Functional Disability Inventory: child and parent version scales, Children's Depression Inventory, and the Multidimensional Anxiety Scale for Children, as well as safety and tolerability. Of the 184 participants, 149 (80.98%) completed the 13-week treatment.
The mean change in BPI average pain severity was comparable in patients who received duloxetine vs placebo (−1.62 vs −0.97, respectively; P =.052). Secondary outcomes were also comparable in the 2 groups, with the exception of treatment response (ie, 30% or 50% reduction in pain intensity) and the general activity and relationships items on the BPI-Modified Short Form: Interference Subscale, all of which were greater in participants taking duloxetine vs placebo.
More participants in the duloxetine group reported ≥1 treatment-emergent adverse effects compared with participants in the placebo group (82.42% vs 62.37%, respectively; P =.003).
Upadhyaya H, Arnold L, Alaka K, et al. Efficacy and safety of duloxetine versus placebo in adolescents with juvenile fibromyalgia: results from a phase 3b, randomized study. Presented at the World Congress on Pain 2018; September 12-16, 2018; Boston, MA. Poster 64517.
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