Duloxetine May Be Ineffective in Juvenile Primary Fibromyalgia

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Study participants were randomly assigned to receive duloxetine or placebo for a period of 13 weeks.
Study participants were randomly assigned to receive duloxetine or placebo for a period of 13 weeks.

The following article is part of conference coverage from the IASP 2018 conference in Boston, Massachusetts. Clinical Pain Advisor's staff will be reporting breaking news associated with research conducted by leading experts in pain medicine. Check back for the latest news from IASP 2018.

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).

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Reference

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.

For more coverage of IASP 2018, click here.

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