From the American College of Rheumatology
WASHINGTON, DC—The anticonvulsant pregabalin (Lyrica), indicated for neuropathic pain and seizures, appears to provide patients with fibromyalgia long-term symptom relief. New data presented at the American College of Rheumatology annual meeting suggest that this agent may reduce pain and fatigue, as well as improve sleep quality in these patients.
This placebo-controlled, double-blind trial included 1051 patients (mean age, 50 years) with baseline mean fibromyalgia syndrome duration of 7.8 years and mean visual analog scale (VAS) pain score of 78 (maximum possible, 100 points). The majority of the patients (93%) were women, and most (88%) were white.
In a screening phase, patients were “washed out of prohibited medicines.” This was followed by a 6-week, open-label phase, in which patients were randomized to 1 of 3 pregabalin groups: 300, 450, or 600 mg/day. The dosages were adjusted to optimize pain control as tolerated.
After 6 weeks, 63% of patients had a >50% reduction in VAS pain score and were rated as “much” or “very much” improved. Of this group, 566 were entered into a 26-week, double-blind study and received pregabalin (n = 279) at the optimal dosage established in the initial phase, or placebo (n = 287).
Symptom worsening was reported by 25% of the placebo-treated patients at day 7 compared with at day 34 by pregabalin-treated patients. At the end of the 26 weeks, nearly twice as many placebo-receiving patients had lost response compared with those in the treatment group (61% vs 32%).
“We found that those patients on medication experienced a reduction in pain, an improvement in sleep, an improvement in fatigue, improvement in function, and an improvement in quality of life,” said lead investigator Leslie Crofford, MD, Gloria W. Singletary Professor of Rheumatology and Women’s Health at the University of Kentucky, Lexington. “We were actually surprised by the robustness of the findings.”
The most common treatment-related adverse events during the open-label phase were dizziness (36%) and somnolence (22%). In the double-blind phase, side effects more common in the pregabalin than the placebo group were sinusitis (5% vs 3%) and arthralgia and anxiety (5% vs 2%). Dr Crofford said most adverse events were mild or moderate in intensity.
“Until now, we have not had good alternative therapies to the currently used armamentarium of antidepressants. The importance of this study is that it confirms that this agent is an alternate strategy other than antidepressants for the treatment of fibromyalgia,” Dr Crofford told . “We were able to show that two thirds of the patients who respond to the agent have maintenance of that benefit over 6 months’ time. So that is a very important finding for physicians and their patients to know.”
Addressing pregabalin’s potential for treating fibromyalgia, Dr Crofford said, “The theory behind the beneficial effect in neuropathic pain and fibromyalgia pain is that there is sensitization of the dorsal neurons, which are maintained in an activated state. So pregabalin comes in and tames these neurons down.”
• No specific treatment is currently available for fibromyalgia; antidepressants are often used to control the symptoms.
• This study shows that pregabalin may be a viable alternative, providing long-term symptom relief.
• Significant reductions in pain and fatigue were accompanied by improvements in sleep and quality of life.