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

Journal of Pain Research, 2014 · DOI: http://dx.doi.org/10.2147/JPR.S63028 · Published: July 28, 2014

Simple Explanation

This study assessed the long-term safety and tolerability of pregabalin in Japanese patients suffering from central neuropathic pain. The research involved a 53-week open-label trial where patients received pregabalin to manage pain resulting from spinal cord injury, multiple sclerosis, or cerebral stroke. The study found that pregabalin was generally well-tolerated and provided sustained efficacy in managing chronic central neuropathic pain over the treatment period.

Study Duration

53 weeks

Participants

103 Japanese patients with central neuropathic pain

Evidence Level

Not specified

Key Findings

1
A majority of patients (87.4%) experienced at least one treatment-related adverse event, most commonly somnolence, weight gain, dizziness, or peripheral edema.
2
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.
3
Improvements in SF-MPQ VAS score were evident at week 2 and were sustained throughout the treatment period.

Research Summary

The study aimed to evaluate the long-term safety and tolerability of pregabalin in Japanese patients with central neuropathic pain over a 53-week period. The results indicated that pregabalin was generally well-tolerated, with the most common adverse events being somnolence, weight gain, dizziness, and peripheral edema, most of which were mild to moderate in intensity. The study also demonstrated that pregabalin provided sustained efficacy in reducing pain and improving patient function, as measured by the SF-MPQ and mBPI-10, over the 53-week treatment period.

Practical Implications

Clinical Practice

Pregabalin can be considered a viable option for long-term management of central neuropathic pain in Japanese patients.

Future Research

Further studies with a placebo control are needed to confirm the efficacy of pregabalin in this patient population.

Patient Education

Patients should be informed about the potential for side effects such as somnolence, weight gain, dizziness, and peripheral edema when starting pregabalin treatment.

Study Limitations

1
The open-label design may bias patient assessment of pain because of their inherent desire to improve.
2
The relatively small sample size, particularly for patients with multiple sclerosis, limits the extent to which our findings can be generalized beyond the specific populations included in our study.
3
Our interpretation of our efficacy results is constrained by the lack of a placebo control or active comparator.

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