Pregabalin (brand name, Lyrica), used to help relieve certain types of nerve pain or seizures, is also being studied as a possible treatment for fibromyalgia. According to research presented at the November 2006 American College of Rheumatology Annual Scientific Meeting, pregabalin appears to offer sustained pain relief for fibromyalgia patients.
Purpose of the Study: The primary goal of this study was to determine how long therapeutic responses to pregabalin lasted.
How the Study Was Conducted: In the first phase of the study, 1,051 patients were treated with pregabalin, and the dose was titrated (adjusted) for appropriate effect. Of these 1,051 patients, 633 patients had a greater than 50 percent response to treatment, and agreed to participate in the second phase. Of those, 566 moved onto phase two, where they were randomized to a double-blind study. In phase two, which lasted 26 weeks, 279 received pregabalin at the optimal dosage established, and 287 received a placebo. The patients did not know if they were getting the active medicine or the placebo.
Results: One-fourth of the placebo group reported a worsening of symptoms by the seventh day of phase two compared to day 32 for the group receiving pregabalin. By the end of phase two, nearly twice as many of the patients receiving the placebo (61 percent) had lost therapeutic response compared with 32 percent of those receiving the pregabalin. The most common side-effects reported were dizziness, drowsiness, sinusitis, joint pain and anxiety. Most side-effects were mild to moderate in intensity. Two deaths occurred during the study (one from each group), but neither was considered treatment related.
Conclusion: In the subset of patients who respond well to pregabalin, it demonstrated longer-term pain relief for fibromyalgia compared to a placebo. However, not all patients have significant symptom relief from Pregabalin treatment. It is not clear how this treatment compares to other medications for symptom relief.
Source: Crawford, L.J., et al. “A Six-month, Double-blind, Placebo-controlled, Durability of Effect Study of Pregabalin for Pain Associated With Fibromyalgia.” American College of Rheumatology Annual Scientific Meeting. November 2006.
