Pregabalin Effective in Treating FM In the April issue of Arthritis and Rheumatism, lead researcher Dr. Leslie Crofford and her team published the results of their study of pregabalin as a treatment for fibromyalgia. “Pregabalin works by inhibiting the excitability of neurons, and we believe that pain transmitting neurons are activated in FMS patients,” explains Crofford. “It also blocks the release of pain transmitting substances. We thought it was quite likely to work, but the hard part was convincing the company that a large study could be done in FMS patients.” In the end, the researchers were able to set up a multi-center, double-blind, randomized clinical trial testing the effects of placebo with 150-, 300-, and 450-mg daily doses of pregabalin on pain, sleep, fatigue, and quality of life in more than 500 FM patients. They discovered that the 450-mg dose significantly reduced the average severity of pain and improved health-related quality of life. Doses of 450- and 300-mg significantly improved sleep quality and fatigue. “I was not surprised that the medication worked well in FMS patients,” says Crofford. “Pregabalin is known to relieve pain, improve sleep, and reduce anxiety in animals. In addition, we knew that pregabalin was effective in patients with neuropathic pain, such as post-herpetic neuralgia and diabetic neuropathy.” The most frequent adverse effects were dizziness and drowsiness. She notes that doses higher than 450-mg are being tested now, and that researchers will have to balance out pain relief benefits with the side effects. “Since pregabalin has a completely different mechanism from most commonly used drugs for FMS, we believe that this work will expand options for our patients,” she says. “It is now quite clear from this and other studies that FMS can be treated effectively and that this group of patients, in whom current treatments are often inadequate, should be actively studied with an eye toward developing this and other new treatments.” It is anticipated that pregabalin will be in pharmacies in September, approved for treatment of neuropathic pain, but studies are ongoing. Patient participation is needed to ultimately gain FDA approval of pregabalin for FM.