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No significant improvement in mean pain score seen with pregabalin for adolescents with fibromyalgia
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Although a trial showed pregabalin was not effective in reducing the mean pain score of adolescents with fibromyalgia, investigators found improvement in some secondary outcomes, such as impression of change, according to a recently published study.
In a 15-week, randomized, double-blind, placebo-controlled study followed by a 6-month open-label safety trial, 107 patients aged 12 years to 17 years who met Yunus and Masi criteria were evaluated primarily for pain and for secondary outcomes of global assessment, measures of pain, sleep and fibromyalgia impact. Fifty-four patients received pregabalin (Lyrica, Pfizer) and 53 received placebo at 36 centers internationally. Eighty patients completed the study.
Leslie Arnold
Patients completed pain diaries for 7 days prior to induction, and patients were excluded in the presence of other musculoskeletal conditions or other potential confounding sources of pain.
Patients who received pregabalin began with 75 mg per day through the end of week 1 and increased their dosage during 3 weeks according to investigators’ evaluations of safety, from 150 mg per day to 300 mg per day or 450 mg per day for 12 weeks. Pain diaries were completed daily with a 24-hour recall period. More than 70% of patients in both treatment and placebo groups received concomitant treatment with ibuprofen, acetaminophen, naproxen or a bronchodilator.
A statistically insignificant trend toward improvement in the mean pain score was found for patients who received pregabalin compared to patients who received placebo. A significant change in the weekly pain score was observed among patients in the treatment group compared to the placebo group, and greater changes in pain scores at week 15 were also observed.
The patient global impression of change response improved in 53.1% of patients in the treatment group compared to 29.5% of patients who received placebo. The parent global impression of change was 51% in the treatment group compared to 25% of parents of patients who received placebo. No significant differences were observed between groups in 30% or 50% responders.
Disclosures: Arnold reports an association with the University of Cincinnati College of medicine. Please see the full study for a list of all other authors’ relevant financial disclosures.
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Arnold LM. Ped Rheumatol.2015;doi:10.1186/s12969-016-0106-4.
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