Safety and efficacy of pregabalin in patients with post-stroke pain

  Central Post-stroke Pain (CPSP) is a neuropathic pain syndrome that is characterized by persistent or intermittent pain in part of the limb with sensory abnormalities that occurs after a stroke. CPSP can be caused by injury to any segment of the spinal thalamic tract conduction pathway, and most patients experience pain within 6 months after stroke, while some patients have reported pain symptoms 2-3 years after stroke.  The chance of developing CPSP after stroke is estimated to be about 1-8%. However, current treatment for CPSP is very limited, mainly antidepressants, antiepileptics, antiarrhythmics, opioids, and NMDA receptor antagonists, but none of them are effective in relieving pain. Pregabalin binds to the α2-delta subunit of voltage-gated calcium channels and modulates the release of several neurotransmitters, thereby affecting pain transmission.1 A randomized, double-blind, placebo-controlled, 13-week clinical study involving multiple countries and multiple centers enrolled 219 patients with post-stroke neuropathic pain, randomized to the pregabalin group (110 patients, oral pregabalin 150-600 mg/d) and placebo group (109 patients). The follow-up indicators were mean pain score, the degree of pain impact on sleep, and quality of life score. The pain scores (numerical analogue score, NRS) in the pregabalin and placebo groups decreased from 6.5 and 6.3 before treatment to 5.0 to 4.9 after treatment, respectively, without statistical significance (P=0.578); however, the quality of sleep, anxiety/depression scores and overall impression of clinical improvement were significantly improved in the pregabalin group compared with the placebo group (P<0.05); the incidence of adverse effects The incidence of adverse reactions was higher in the pregabalin group than in the placebo group, with 9 cases (8.2%) of discontinuation in the pregabalin group compared with 4 cases (3.7%) in the placebo group due to adverse reactions.  Therefore, this study concluded that although pregabalin did not significantly improve pain scores in patients with post-stroke neuralgia, it significantly improved quality of life such as sleep and anxiety/depression.