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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.
Pain Pract. 2016 07; 16(6):720-9.PP

Abstract

INTRODUCTION

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.

LIMITATIONS

Small sample size, geographical bias, relatively short duration of treatment, and single-arm study without control group.

CONCLUSIONS

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.

Authors+Show Affiliations

Carolinas Pain Institute and Center for Clinical Research, Winston-Salem, North Carolina, U.S.A. Wake Forest University Baptist Medical Center, Pain Medicine and Anesthesiology, Winston-Salem, North Carolina, U.S.A.The Center for Clinical Research, Winston-Salem, North Carolina, U.S.A.Carolinas Pain Institute and Center for Clinical Research, Winston-Salem, North Carolina, U.S.A.

Pub Type(s)

Clinical Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26059271

Citation

North, James M., et al. "The Effect of a Novel Form of Extended-Release Gabapentin On Pain and Sleep in Fibromyalgia Subjects: an Open-Label Pilot Study." Pain Practice : the Official Journal of World Institute of Pain, vol. 16, no. 6, 2016, pp. 720-9.
North JM, Hong KS, Rauck RL. The Effect of a Novel form of Extended-Release Gabapentin on Pain and Sleep in Fibromyalgia Subjects: An Open-Label Pilot Study. Pain Pract. 2016;16(6):720-9.
North, J. M., Hong, K. S., & Rauck, R. L. (2016). The Effect of a Novel form of Extended-Release Gabapentin on Pain and Sleep in Fibromyalgia Subjects: An Open-Label Pilot Study. Pain Practice : the Official Journal of World Institute of Pain, 16(6), 720-9. https://doi.org/10.1111/papr.12319
North JM, Hong KS, Rauck RL. The Effect of a Novel Form of Extended-Release Gabapentin On Pain and Sleep in Fibromyalgia Subjects: an Open-Label Pilot Study. Pain Pract. 2016;16(6):720-9. PubMed PMID: 26059271.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Effect of a Novel form of Extended-Release Gabapentin on Pain and Sleep in Fibromyalgia Subjects: An Open-Label Pilot Study. AU - North,James M, AU - Hong,Kyung-Soo J, AU - Rauck,Richard L, Y1 - 2015/06/08/ PY - 2014/06/12/received PY - 2015/04/07/accepted PY - 2015/6/11/entrez PY - 2015/6/11/pubmed PY - 2017/2/15/medline KW - Fibromyalgia Impact Questionnaire KW - MOS sleep questionnaire KW - chronic pain KW - depression KW - extended release gabapentin (GER) KW - fibromyalgia KW - gabapentin KW - gastroretentive gabapentin KW - numeric pain rating system SP - 720 EP - 9 JF - Pain practice : the official journal of World Institute of Pain JO - Pain Pract VL - 16 IS - 6 N2 - INTRODUCTION: 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. LIMITATIONS: Small sample size, geographical bias, relatively short duration of treatment, and single-arm study without control group. CONCLUSIONS: 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. SN - 1533-2500 UR - https://www.unboundmedicine.com/medline/citation/26059271/The_Effect_of_a_Novel_form_of_Extended_Release_Gabapentin_on_Pain_and_Sleep_in_Fibromyalgia_Subjects:_An_Open_Label_Pilot_Study_ L2 - https://doi.org/10.1111/papr.12319 DB - PRIME DP - Unbound Medicine ER -