Roy Freeman, MD, director, Center for Autonomic and Peripheral Nerve Disorders, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, and associates assessed the effect of pregabalin treatment on sleep disturbance in patients with diabetic peripheral neuropathy, post-herpetic neuralgia, spinal cord injury, fibromyalgia syndrome, and osteoarthritis.

Patients were drawn from 13 randomised, controlled studies of chronic pain syndromes that included sleep measures as secondary efficacy measures. Trials lasted 5 to 13 weeks and included 146 to 529 patients in their intent-to-treat populations.

Most patients received fixed dosages of 150 to 600 mg/day and were asked to maintain pain and sleep journals. "Our results show that beyond the relief of pain, pregabalin confers the added benefit of improving the sleep interference that is commonly comorbid with chronic pain," Dr. Freeman and colleagues observed in their poster.

Results showed that pregabalin treatment significantly decreased pain and pain-related sleep disturbances by week 1 in patients with all except those with osteoarthritis. These improvements persisted throughout the trial.

An analysis of data from the Medical Outcomes Study (MOS)-Sleep Scale, which was administered in 6 of the trials, showed that pregabalin significantly reduced sleep disturbance and significantly improved overall sleep index and sleep adequacy components of the scale.

Sleep measures improved significantly in osteoarthritis patients, even though the medication did not have a marked effect on pain.

In a trial of healthy volunteers polysomnography found that pregabalin treatment significantly increased the time spent in stages III to IV sleep while decreasing nighttime awakenings compared with placebo (P <.001).

"Our results show that beyond the relief of pain, pregabalin confers the added benefit of improving the sleep interference that is commonly comorbid with chronic pain," Dr. Freeman observed.

Pregabalin is approved in the US for the treatment of neuropathic pain associated with diabetic peripheral neuropathy and post-herpetic neuralgia.

The study was sponsored by Pfizer Global Pharmaceuticals.


[Presentation title: Pregabalin Rapidly and Significantly Improves Sleep Disturbances in Chronic Pain Syndromes and Is Associated With Sleep Improvements in Healthy Volunteers. Abstract P04.010]

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