Study Shows Pregabalin Effective in Difficult-to-Treat Nerve Pain

ข่าวต่างประเทศ Tuesday November 28, 2006 16:46 —Asianet Press Release

SYDNEY--28 Nov--PRNewswire-AsiaNet/InfoQuest Results Offer Hope to Patients with Excruciating Chronic Pain Findings from a new study published today in the journal Neurology demonstrate that the oral medication pregabalin is significantly effective in relieving central neuropathic (nerve) pain and improves pain-related sleep disturbance and anxiety in patients with spinal cord injury. Conducted by researchers at the Pain Management Research Institute in Sydney, the study is the largest controlled clinical trial ever of patients with spinal cord injury who suffer from central neuropathic pain, a particularly persistent and severe pain condition. Results from the study showed that patients using pregabalin (150-600 mg/day) experienced significant improvements in symptoms as early as the first week of treatment and those improvements were sustained throughout the study. Patients taking pregabalin experienced a significant reduction in the average intensity of their pain and significant improvements in pain-related sleepinterference as well as a reduction in anxiety compared to those taking placebo. "Historically it has been extremely difficult to manage patients with central neuropathic pain due to a lack of effective treatments and many people with spinal cord injury have excruciating pain," said Prof. Philip Siddall, lead investigator of the study and Clinical Associate Professor at the Pain Management Research Institute in Sydney. "The study demonstrates that pregabalin is an effective and well-tolerated therapy for treating a range of symptoms that can negatively impact overall quality of life. This study is an important step forward for clinicians trying to improve the lives of patients suffering from difficult-to-treat nerve pains." Approximately two-thirds of patients with spinal cord injury often suffer from severe central neuropathic pain(1,2), which is caused by a lesion or dysfunction in the central nervous system(3). Patients often describe the symptoms of their pain as burning, tingling, stabbing, shooting, pricking, scalding and freezing(4,5,6). Chronic pain following spinal cord injury may limit a patient's ability to perform daily activities(7). Consequently, quality of life may be impaired(8). Central neuropathic pain can occur in patients withspinal cord injury, stroke, multiple sclerosis and neoplasia. Pregabalin is believed to work by calming hyper-excited neurons or nerve cells which may be an underlying cause for various types of nerve pain. Based on the results of this study, pregabalin recently became the only therapy to receive European regulatory approval in central neuropathic pain. About the Study The study, sponsored by pregabalin (Lyrica(R)) developer Pfizer Inc, was a multicentre, parallel-group, double-blind, randomised clinical trial comparing pregabalin with placebo over a 12-week treatment period in patients with spinal cord injury who had central neuropathic pain as defined by the International Association for the Study of Pain classification. The 12-week treatment period was preceded by a 1-week baseline period during which baseline data were collected. Patients were randomised to receive either flexible dose pregabalin (150-600 mg/day) (n=70) or placebo (n=67) taken twice daily. The primary endpoint of the study was mean pain score as measured by patient pain diary assessments which were completed daily. Patients also rated the extent to which pain interfered with sleep in a daily diary. Changes in anxiety were evaluated using the Hospital Anxiety and Depression Scale (HADS). Results from the study showed that: * Patients receiving pregabalin experienced significant improvements in symptoms as early as the first week of treatment and those improvements were sustained throughout the study * Patients receiving pregabalin experienced a significant reduction in the average intensity of their pain and significant improvements in pain- related sleep interference (p

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