An open-label, long-term study examining the safety and tolerability of pregabalin in Japanese patients with central neuropathic pain

Abstract

PurposeStudies of pregabalin for the treatment of central neuropathic pain have been limited to double-blind trials of 4–17 weeks in duration. The purpose of this study was to assess the long-term safety and tolerability of pregabalin in Japanese patients with central neuropathic pain. The efficacy of pregabalin was also assessed as a secondary measure.Patients and methodsThis was a 53-week, multicenter, open-label trial of pregabalin (150–600 mg/day) in Japanese patients with central neuropathic pain due to spinal cord injury, multiple sclerosis, or cerebral stroke.ResultsA total of 103 patients received pregabalin (post-stroke =60; spinal cord injury =38; and multiple sclerosis =5). A majority of patients (87.4%) experienced one or more treatment-related adverse events, most commonly somnolence, weight gain, dizziness, or peripheral edema. The adverse event profile was similar to that seen in other indications of pregabalin. Most treatment-related adverse events were mild (89.1%) or moderate (9.2%) in intensity. Pregabalin treatment improved total score, sensory pain, affective pain, visual analog scale (VAS), and present pain intensity scores on the Short-Form McGill Pain Questionnaire (SF-MPQ) and ten-item modified Brief Pain Inventory (mBPI-10) total score at endpoint compared with baseline. Improvements in SF-MPQ VAS and mBPI-10 total scores were evident in all patient subpopulations. Mean changes from baseline in SF-MPQ VAS and mBPI-10 scores at endpoint were −20.1 and −1.4, respectively.ConclusionThese findings demonstrate that pregabalin is generally well tolerated and provides sustained efficacy over a 53-week treatment period in patients with chronic central neuropathic pain.

Characteristics of Ocular Pain Complaints in Patients With Idiopathic Dry Eye Symptoms

“…In order to make data from the current dry eye sample comparable to these studies, only subjects who rated their average eye pain during the past week as at least 4 out of 10 on a NRS were included, as this was equivalent to the inclusion criteria for the previously published studies that were used for comparison. 32-35 Our patient cohort fell in the mid-range of scores compared to the other data taken from the literature, and appears most similar to the central neuropathic pain patients studied by Onouchi et al 33 …”

“… SF-MPQ=short-form McGill Pain Questionnaire; SD=standard deviation. Siddall et al study 32 included patients with central neuropathic pain conditions from spinal cord injury. Onouchi et al study 33 included patients with central neuropathic pain conditions from spinal cord injury (37%), cerebral stroke (58%), and multiple sclerosis (5%). * In order to make data from the current dry eye sample comparable to those from the literature, only subjects who rated their average eye pain during the past week at least 4 out of 10 on a NRS were included. † P value comparison of means between non-ocular pain population and dry eye population <0.05 (2 tailed independent t test). …”

“…Onouchi et al study 33 included patients with central neuropathic pain conditions from spinal cord injury (37%), cerebral stroke (58%), and multiple sclerosis (5%).…”

A review of the drug pregabalin

“…The findings demonstrated that PGB is generally well-tolerated and provides a sustained efficacy over 53-week treatment period in patients with chronic central neuropathic pain. 8 A randomized double-blind placebo (PL) controlled study was done by Mishra et al, in 2012 to evaluate the comparative clinical efficacy of amitriptyline, gabapentin, and PGB in neuropathic cancer pain. A total of 120 patients were enrolled in the study and divided into four groups.…”

The Effect of Pregabalin on the Quality of Life in Patients with Central Post-Stroke Pain

“…However, the use of pregabalin for CPSP still requires further research. 10 Pregabalin in the United States is registered for diabetic neuropathy pain therapy, spinal cord injury, post-herpetic neuralgia, and adjunctive therapy for adult partial seizure. In Europe, pregabalin is indicated for the treatment of central and peripheral neuropathic pain, epilepsy, and generalized anxiety disorder.…”