Efficacy of pregabalin in post-traumatic peripheral neuropathic pain: a randomized, double-blind, placebo-controlled phase 3 trial

AbstractThe growing need for symptomatic treatment of post-traumatic neuropathic pain (PTNP) continues  to be unmet. Studies evaluating the efficacy of pregabalin for reducing neuropathic pain following trauma and surgery yielded positive results over ≤ 8-week treatment. To assess the efficacy and tolerability of pregabalin over 3 months in patients with PTNP, a randomized, double-blind, placebo -controlled, parallel-group trial evaluated patients with PTNP at 101 centers in 11 countries—the longest, largest such trial. Adults diagnosed with PTNP were randomly assigned (1:1) to 15 weeks of pregabalin (flexibly dosed 150–600 mg/day) or matching placebo. Primary efficacy analysis was by mixed-model repeated measures comparing change from baseline to week 15 in weekly mean pain scores between active and placebo groups. Evaluable patients included 274 in the pregabalin group and 265 in the placebo group. Trauma was surgical in 49.6% of patients, non-surgical in the remainder. The pri mary efficacy analysis showed no statistically significant difference between pregabalin and placebo groups in the change from baseline to week 15 [mean difference, − 0.22 points (95% confidence interval, 0.54–0.10);p = 0.1823]. However, comparisons for key secondary outcome measures yieldedp values  
Source: Journal of Neurology - Category: Neurology Source Type: research

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Source: SafetyLit - Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news
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Source: SafetyLit - Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news
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Source: International Journal of Risk and Safety in Medicine - Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research
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Source: Journal of Behavioral Medicine - Category: Psychiatry Source Type: research
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Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
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Source: The Journal of Headache and Pain - Category: Neurology Source Type: research
Headache disorders are highly prevalent and debilitating, with limited treatment options. Previous studies indicate that many proinflammatory immune cells contribute to headache pathophysiology. Given the well-recognized role of regulatory T (Treg) cells in maintaining immune homeostasis, we hypothesized that enhancing Treg function may be effective to treat multiple headache disorders. In a mouse model of chronic migraine, we observed that repeated nitroglycerin (NTG, a reliable trigger of migraine in patients) administration doubled the number of CD3+ T cells in the trigeminal ganglia without altering the number of Treg ...
Source: Pain - Category: Anesthesiology Tags: Research Paper Source Type: research
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Source: The American Journal of Emergency Medicine - Category: Emergency Medicine Authors: Source Type: research
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Source: Accident; Analysis and Prevention. - Category: Accident Prevention Authors: Tags: Accid Anal Prev Source Type: research
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Source: Fight Aging! - Category: Research Authors: Tags: Medicine, Biotech, Research Source Type: blogs
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