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SAN FRANCISCO, CA—The safety and tolerability of pregabalin for the treatment of fibromyalgia-associated pain does not differ by baseline pain severity, a pooled analysis of five Phase 3 clinical trials presented at the 2015 ACR/ARHP Annual Meeting has shown.
In addition, treatment-emergent adverse events and incidence rates “were consistent with the known safety profile of pregabalin,” Andrew Clair, PhD, of Pfizer Inc, New York, NY, reported.
Pregabalin is currently approved for the treatment of fibromyalgia pain but studies have not examined its safety in patients with different baseline pain severities. Dr. Clair and a colleague pooled safety data from 5 placebo-controlled clinical trials that used pregabalin for 8 to 15 weeks at doses of 300mg or 450 mg/day for treatment of fibromyalgia-related pain.
Fibromyalgia was diagnosed using 1990 ACR criteria. Patients were aged ≥18 years and had mean baseline pain scores ≥4 as well as scores ≥40mm on the Visual Analog Scale of the Short-form McGill Pain Questionnaire.
They used descriptive statistics to classify adverse event profiles after 12 weeks of treatment that were categorized by baseline moderate (pain scores ≥4 to <7) or severe (≥7 to 10) pain.
Incidences of treatment-emergent and treatment-related adverse events (AEs), serious AEs, severe intensity treatment-emergent AEs, as well as permanent or temporary discontinuation due to treatment emergent AEs “were comparable between subjects with baseline moderate and severe pain who received the same treatment,” Dr. Clair reported.
“The incidences of the most common treatment-emergent AEs were also comparable between subjects within the same treatment group who had moderate and severe baseline pain severity,” he added.
These included constipation, diarrhea, dizziness, dry mouth, fatigue, headache, nasopharyngitis, nausea, peripheral edema, somnolence, blurred vision, and increased weight.
“We believe this study is the first to find that adverse event profiles are similar among subjects with baseline moderate or severe pain treated with pregabalin,” noted Dr. Clair. These study findings of a similar safety profile may be important for patients with severe fibromyalgia who present with higher disease burden.
