The Effect of a Novel form of Extended-Release Gabapentin on Pain and Sleep in Fibromyalgia Subjects: An Open-Label Pilot Study

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The Effect of a Novel form of Extended-Release Gabapentin on Pain and Sleep in Fibromyalgia Subjects: An Open-Label Pilot Study
Key Take-Away: 

Fibromyalgia is a condition that affects the muscles and soft tissue. The symptoms of fibromyalgia can be relieved through medications, lifestyle changes and stress management. Among drugs, gabapentin is extensively used. The most agile ingredient in Neurontin is gabapentin which is used to treat neuropathic pain, epilepsy, hot flashes and restless leg syndrome. The researchers of this study have put light on the efficacy and safety of gabapentin in dealing with fibromyalgia.

We assessed the efficacy and safety of extended-release gabapentin in a 15-week, open-label, single-arm, single-center study in patients with fibromyalgia (FM).

ABSTRACT: 
Background: 

We assessed the efficacy and safety of extended-release gabapentin in a 15-week, open-label, single-arm, single-center study in patients with fibromyalgia (FM).

Methods: 

Subjects with documented diagnosis of FM were allowed to participate in the study.

We opened enrollment to those who have tried and failed gabapentinoids such as gabapentin or pregabalin due to side effects. Subjects with autoimmune conditions, and or taking opioids for management of their FM pain, were excluded from the study. Subjects were given an extended-release gabapentin starter pack and treated for total of 12 weeks. The primary study endpoint of pain relief was measured using Numeric Pain Rating System (NPRS) scores, and secondary study endpoints were measured with Fibromyalgia Impact Questionnaire (FIQ), Patient's Global Impression of Change (PGIC), and Medical Outcome Sleep questionnaires (MOS).

Results: 

A total of 34 subjects were enrolled and 29 subjects completed the starter pack (85%).

Patients reported significant pain relief on NPRS by end of 4 weeks (P < 0.0001) on NPRS. Subjects also reported similar magnitude of improvements in FM and its impact on daily life by end of 4 weeks on FIQ (P < 0.0001). Survey of MOS showed our subjects reporting improved sleep quantity (on average, 1.2 hours over baseline) with gradual and statistically significant improvement in quality. Improvements in primary and secondary measurements were reflected in PGIC, with significant improvement in patient's impression of FM by week 8.

Conclusion: 

Extended-release gabapentin relieved FM pain symptoms and improved quality-of-life for the FM subjects studied. Subjects reported improvements in both quantity and quality of sleep.

Pain Pract. 2016 Jul;16(6):720-9
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