Usefulness of pregabalin in adolescents with fibromyalgia
Fibromyalgia (FM) is a familiar pain condition marked by widespread musculoskeletal pain and tenderness. In the United States, pregabalin is an approved treatment for adults, but there are no approved treatments for adolescents with FM.
Thus, for treating adolescents (12-17 years) with FM, a 15-week, randomized, double-blind, placebo-controlled study and 6-month open-label safety trial of flexible-dose pregabalin (75-450 mg/day) was conducted. The alteration in mean pain score at endpoint (scored from 0-10, with 24-h recall) was the primary outcome. Whereas, global assessments and measures of pain, sleep, and FM impact were a part of the secondary outcome.
A total of 107 patients were randomized to treatment (54 pregabalin, 53 placebo) and 80 accomplished the study (44 pregabalin, 36 placebo). Upgrade in mean pain score at endpoint with pregabalin versus placebo was not statistically important, treatment difference (95 % CI), -0.66 (-1.51, 0.18), P = 0.121. There were appreciable 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). Inclination towards improvement with pregabalin in other secondary outcomes measuring pain, sleep, and FM impact were not notable. In adults with FM, safety was consistent with the known profile of pregabalin.
Hence, it was rendered that pregabalin did not significantly improve the mean pain score in adolescents with FM. Significant improvements in secondary outcomes measuring pain and impression of change were observed.