Brett R Stacey *, 1
, Birol Emir 2, Danielle Petersel 2, Kevin Murphy 2
1 Comprehensive Pain Center, Department of Anesthesiology and Peri-Operative Medicine, Oregon Health & Science University, Portland, OR, USA
2 Pfizer Pharmaceuticals Group, New York, NY, USA
Context: Fibromyalgia is a chronic musculoskeletal pain disorder. The pain can be intractable and may not respond to commonly-used treatments, such as tricyclic antidepressants and opioids.
Objectives: To evaluate pregabalin response in the subset of patients with fibromyalgia whose pain had been judged refractory to other treatments.
Methods: Patients had previously participated in a controlled trial of pregabalin and had moderate to severe pain despite treatment with gabapentin, a tricyclic antidepressant, and a third medication (e.g., other anticonvulsants, opioid, selective serotonin reuptake inhibitors, tramadol). Flexible-dose pregabalin 150-600 mg/day was added for 3-month treatment cycles, each followed by 3- to 28-day pregabalin “drug holiday” that lasted until a relapse occurred. Pain intensity was measured using the visual analogue scale of the Short-Form McGill Pain Questionnaire completed at baseline, the end of each 3-month treatment period and at the relapse visit. Analysis was at 15 months (after 5 cycles).
Results: In total, 25 patients were included and 19 completed the 15-month analysis period. At baseline, 88% were receiving ≥1 pain medication. Pregabalin 150-600 mg/day was associated with statistically significant, clinically meaningful pain reduction during each treatment cycle. Pain quickly returned to baseline levels during the “drug holidays” in a median time of 2-4 days. Somnolence (n=5) and dizziness (n=4) were the most common adverse events.
Conclusions: These results suggest that pregabalin may be beneficial in patients with fibromyalgia who have had an unsatisfactory response to treatment with other medications.
open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.
* Address correspondence to this author at the Department of Anesthesiology and Peri-operative Medicine, Oregon Health & Science University, Comprehensive Pain Center CH4P and 3303 SW Bond Ave, Portland, OR 97239, USA; Tel: 503 494 7246; Fax: 503 494 7635; E-mail: email@example.com