Advertisement	December 24, 2014 Pregabalin Not Effective for Common Lower Back Pain Despite ‘Off-Label’ Use Rochester, NY—Despite its common use as an “off label” treatment for conditions such as lumbar spinal stenosis, pregabalin is not effective in controlling the pain associated with chronic lower back pain, according to a new study. The report was published recently in the journal Neurology. “Chronic low back pain is one of the most common reasons why older adults go to the doctor and lumbar stenosis is the leading indication for surgery in this age group,” said lead author John Markman, MD, director of the Translational Pain Research Program in the University of Rochester Department of Neurosurgery. “While physicians have increasingly looked for medication alternatives to opioid pain medication, like gabapentin and pregabalin to help these patients manage their pain, until now there has been no credible evidence as to whether or not these treatments are effective for this problem.” Pregabalin is marketed by Pfizer, Inc., as Lyrica and is approved to treat chronic pain associated with shingles, spinal cord injury, fibromyalgia, and diabetic peripheral neuropathy. Lumbar spinal stenosis is caused by the narrowing of the spinal canal caused by the degeneration of the vertebrae, discs, muscles, and ligaments that comprise the spinal column. Compressed nerve roots can trigger pain, tingling, and numbness in the lower back, buttocks, and legs. While the surgical option, lumbar laminectomy, often is initially successful, the pain returns for some patients with the passage of years, according to background in the article. As a result, study authors note, physicians are searching for new alternatives for treating the conditions, and as many as two thirds of the pain treatment regimens currently being used for lumbar spinal stenosis are not approved by the FDA for that condition. In the randomized, double-blind, active placebo-controlled, 2-period crossover trial, 29 subjects either received pregabalin followed by active placebo (i.e., diphenhydramine) or active placebo followed by pregabalin. Each treatment period lasted 10 days, with a washout period and a 3-day taper phase after the first period. Because the pain associated with the lumbar spinal stenosis is most often present when patients stand upright or walk, pain levels in the study were assessed while subjects used a treadmill. The primary outcome variable was the time to first moderate pain symptom—over “4”—during a 15-minute treadmill test. Secondary outcome measures included pain intensity at rest, pain intensity at the end of the treadmill test, distance walked, and validated self-report measures of pain and functional limitation. “Pregabalin was not more effective than active placebo in reducing painful symptoms or functional limitations in patients with neurogenic claudication associated with lumbar spinal stenosis,” the authors conclude. “Given the cost and potential side effects associated with pregabalin, it is critical that we understand the efficacy of this drug,” Markman added. “This study convincingly demonstrates a lack of relief with pregabalin for the walking pain associated with lumbar spinal stenosis.” Click here for December 24, 2014 USP Weekly News Update.
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