An evidence-based review of pregabalin for the treatment of fibromyalgia

References

• Queiroz LP. Worldwide epidemiology of fibromyalgia. Curr Pain Headache Rep 2013;17:356
   PubMed Web of Science ®Google Scholar
• Wolfe F, Ross K, Anderson J, et al. The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum 1995;38:19-28
   PubMed Web of Science ®Google Scholar
• Wolfe F, Brähler E, Hinz A, et al. Fibromyalgia prevalence, somatic symptom reporting, and the dimensionality of polysymptomatic distress: results from a survey of the general population. Arthritis Care Res (Hoboken) 2013;65:777-85
   PubMed Web of Science ®Google Scholar
• Vincent A, Lahr BD, Wolfe F, et al. Prevalence of fibromyalgia: a population-based study in Olmsted County, Minnesota, utilizing the Rochester Epidemiology Project. Arthritis Care Res (Hoboken) 2013;65:786-92
   PubMed Web of Science ®Google Scholar
• Branco JC, Bannwarth B, Failde I, et al. Prevalence of fibromyalgia: a survey in five European countries. Semin Arthritis Rheum 2010;39:448-53
   PubMed Web of Science ®Google Scholar
• Haq SA, Darmawan J, Islam MN, et al. Prevalence of rheumatic diseases and associated outcomes in rural and urban communities in Bangladesh: a COPCORD study. J Rheumatol 2005;32:348-53
   PubMed Web of Science ®Google Scholar
• Guermazi M, Ghroubi S, Sellami M, et al. [Fibromyalgia prevalence in Tunisia]. Tunis Med 2008;86:806-11
   PubMedGoogle Scholar
• Senna ER, De Barros AL, Silva EO, et al. Prevalence of rheumatic diseases in Brazil: a study using the COPCORD approach. J Rheumatol 2004;31:594-7
   PubMed Web of Science ®Google Scholar
• White KP, Speechley M, Harth M, et al. The London Fibromyalgia Epidemiology Study: the prevalence of fibromyalgia syndrome in London, Ontario. J Rheumatol 1999;26:1570-6
   PubMed Web of Science ®Google Scholar
• McNally JD, Matheson DA, Bakowsky VS. The epidemiology of self-reported fibromyalgia in Canada. Chronic Dis Can 2006;27:9-16
   PubMedGoogle Scholar
• Mas AJ, Carmona L, Valverde M, et al. Prevalence and impact of fibromyalgia on function and quality of life in individuals from the general population: results from a nationwide study in Spain. Clin Exp Rheumatol 2008;26:519-26
   PubMed Web of Science ®Google Scholar
• Topbas M, Cakirbay H, Gulec H, et al. The prevalence of fibromyalgia in women aged 20–64 in Turkey. Scand J Rheumatol 2005;34:140-4
   PubMed Web of Science ®Google Scholar
• Clauw DJ. Fibromyalgia and related conditions. Mayo Clin Proc 2015;90:680-92
   PubMed Web of Science ®Google Scholar
• Gracely RH, Petzke F, Wolf JM, et al. Functional magnetic resonance imaging evidence of augmented pain processing in fibromyalgia. Arthritis Rheum 2002;46:1333-43
   PubMed Web of Science ®Google Scholar
• Cook DB, Lange G, Ciccone DS, et al. Functional imaging of pain in patients with primary fibromyalgia. J Rheumatol 2004;31:364-78
   PubMed Web of Science ®Google Scholar
• Napadow V, LaCount L, Park K, et al. Intrinsic brain connectivity in fibromyalgia is associated with chronic pain intensity. Arthritis Rheum 2010;62:2545-55
   PubMed Web of Science ®Google Scholar
• Napadow V, Kim J, Clauw DJ, et al. Decreased intrinsic brain connectivity is associated with reduced clinical pain in fibromyalgia. Arthritis Rheum 2012;64:2398-403
   PubMed Web of Science ®Google Scholar
• Jensen KB, Loitoile R, Kosek E, et al. Patients with fibromyalgia display less functional connectivity in the brain’s pain inhibitory network. Mol Pain 2012;8:32
   PubMed Web of Science ®Google Scholar
• Harris RE, Sundgren PC, Craig AD, et al. Elevated insular glutamate in fibromyalgia is associated with experimental pain. Arthritis Rheum 2009;60:3146-52
   PubMed Web of Science ®Google Scholar
• Foerster BR, Petrou M, Edden RA, et al. Reduced insular gamma-aminobutyric acid in fibromyalgia. Arthritis Rheum 2012;64:579-83
   PubMedGoogle Scholar
• Harris RE, Sundgren PC, Pang Y, et al. Dynamic levels of glutamate within the insula are associated with improvements in multiple pain domains in fibromyalgia. Arthritis Rheum 2008;58:903-7
   PubMedGoogle Scholar
• Lopez-Sola M, Woo CW, Pujol J, et al. Towards a neurophysiological signature for fibromyalgia. Pain 2017;158:34-47
   PubMed Web of Science ®Google Scholar
• Mease PJ, Arnold LM, Crofford LJ, et al. Identifying the clinical domains of fibromyalgia: contributions from clinician and patient Delphi exercises. Arthritis Rheum 2008;59:952-60
   PubMed Web of Science ®Google Scholar
• Clauw DJ. Fibromyalgia: a clinical review. JAMA 2014;311:1547-55
   PubMed Web of Science ®Google Scholar
• Schaefer C, Chandran A, Hufstader M, et al. The comparative burden of mild, moderate and severe fibromyalgia: results from a cross-sectional survey in the United States. Health Qual Life Outcomes 2011;9:71
   PubMed Web of Science ®Google Scholar
• Perrot S, Schaefer C, Knight T, et al. Societal and individual burden of illness among fibromyalgia patients in France: association between disease severity and OMERACT core domains. BMC Musculoskelet Disord 2012;13:22
   PubMed Web of Science ®Google Scholar
• Schaefer C, Mann R, Masters ET, et al. The comparative burden of chronic widespread pain and fibromyalgia in the United States. Pain Pract 2016;16:565-79
   PubMed Web of Science ®Google Scholar
• Robinson RL, Kroenke K, Mease P, et al. Burden of illness and treatment patterns for patients with fibromyalgia. Pain Med 2012;13:1366-76
   PubMed Web of Science ®Google Scholar
• Hauser W, Walitt B, Fitzcharles MA, et al. Review of pharmacological therapies in fibromyalgia syndrome. Arthritis Res Ther 2014;16:201
   PubMed Web of Science ®Google Scholar
• Lauche R, Cramer H, Häuser W, et al. A systematic overview of reviews for complementary and alternative therapies in the treatment of the fibromyalgia syndrome. Evid Based Complement Alternat Med 2015;2015:610615
   PubMed Web of Science ®Google Scholar
• Taylor CP, Angelotti T, Fauman E. Pharmacology and mechanism of action of pregabalin: the calcium channel alpha2-delta (alpha2-delta) subunit as a target for antiepileptic drug discovery. Epilepsy Res 2007;73:137-50
   PubMed Web of Science ®Google Scholar
• Fink K, Dooley DJ, Meder WP, et al. Inhibition of neuronal Ca(2+) influx by gabapentin and pregabalin in the human neocortex. Neuropharmacology 2002;42:229-36
   PubMed Web of Science ®Google Scholar
• Cunningham MO, Woodhall GL, Thompson SE, et al. Dual effects of gabapentin and pregabalin on glutamate release at rat entorhinal synapses in vitro. Eur J Neurosci 2004;20:1566-76
   PubMed Web of Science ®Google Scholar
• Lyrica Prescribing Information. New York, NY: Pfizer Inc., 2016. Available at: http://labeling.pfizer.com/ShowLabeling.aspx?id =561 [Last accessed 8 June 2016]
   Google Scholar
• Cymbalta Prescribing Information. Indianapolis, IN: Lilly USA LLC, 2016. Available at: http://pi.lilly.com/us/cymbalta-pi.pdf [Last accessed 21 September 2016]
   Google Scholar
• Savella Prescribing Information. Irvine, CA: Allergan USA Inc., 2016. Available at: http://www.allergan.com/assets/pdf/savella_pi [Last accessed 21 September 2016]
   Google Scholar
• Macfarlane GJ, Kronisch C, Dean LE, et al. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis 2017;76:318-28
   PubMed Web of Science ®Google Scholar
• Fitzcharles MA, Ste-Marie PA, Goldenberg DL, et al. 2012 Canadian guidelines for the diagnosis and management of fibromyalgia syndrome: executive summary. Pain Res Manag 2013;18:119-26
   PubMed Web of Science ®Google Scholar
• Sommer C, Häuser W, Alten R, et al. [Drug therapy of fibromyalgia syndrome. Systematic review, meta-analysis and guideline]. Schmerz 2012;26:297-310
   PubMed Web of Science ®Google Scholar
• Ablin JN, Amital H, Ehrenfeld M, et al. [Guidelines for the diagnosis and treatment of the fibromyalgia syndrome]. Harefuah 2013;152:742-7, 750, 751
   PubMedGoogle Scholar
• Ablin J, Fitzcharles MA, Buskila D, et al. Treatment of fibromyalgia syndrome: recommendations of recent evidence-based interdisciplinary guidelines with special emphasis on complementary and alternative therapies. Evid Based Complement Alternat Med 2013;2013:485272
   PubMedGoogle Scholar
• Crofford LJ, Rowbotham MC, Mease PJ, et al. Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2005;52:1264-73
   PubMed Web of Science ®Google Scholar
• Mease PJ, Russell IJ, Arnold LM, et al. A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. J Rheumatol 2008;35:502-14
   PubMed Web of Science ®Google Scholar
• Crofford LJ, Mease PJ, Simpson SL, et al. Fibromyalgia relapse evaluation and efficacy for durability of meaningful relief (FREEDOM): a 6-month, double-blind, placebo-controlled trial with pregabalin. Pain 2008;136:419-31
   PubMed Web of Science ®Google Scholar
• Arnold LM, Russell IJ, Diri EW, et al. A 14-week, randomized, double-blinded, placebo-controlled monotherapy trial of pregabalin in patients with fibromyalgia. J Pain 2008;9:792-805
   PubMed Web of Science ®Google Scholar
• Pauer L, Winkelmann A, Arsenault P, et al. An international, randomized, double-blind, placebo-controlled, phase III trial of pregabalin monotherapy in treatment of patients with fibromyalgia. J Rheumatol 2011;38:2643-52
   PubMed Web of Science ®Google Scholar
• Ohta H, Oka H, Usui C, et al. A randomized, double-blind, multicenter, placebo-controlled phase III trial to evaluate the efficacy and safety of pregabalin in Japanese patients with fibromyalgia. Arthritis Res Ther 2012;14:R217
   PubMed Web of Science ®Google Scholar
• Roth T, Lankford DA, Bhadra P, et al. Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: a randomized, placebo-controlled, 2-way crossover polysomnography study. Arthritis Care Res (Hoboken) 2012;64:597-606
   PubMed Web of Science ®Google Scholar
• Harris RE, Napadow V, Huggins JP, et al. Pregabalin rectifies aberrant brain chemistry, connectivity, and functional response in chronic pain patients. Anesthesiology 2013;119:1453-64
   PubMed Web of Science ®Google Scholar
• Arnold LM, Arsenault P, Huffman C, et al. Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study. Curr Med Res Opin 2014;30:2069-83
   PubMed Web of Science ®Google Scholar
• Arnold LM, Sarzi-Puttini P, Arsenault P, et al. Efficacy and safety of pregabalin in patients with fibromyalgia and comorbid depression taking concurrent antidepressant medication: a randomized, placebo-controlled study. J Rheumatol 2015;42:1237-44
   PubMed Web of Science ®Google Scholar
• Arnold LM, Schikler KN, Bateman L, et al. Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study. Pediatr Rheumatol Online J 2016;14:46
   PubMed Web of Science ®Google Scholar
• Hauser W, Petzke F, Sommer C. Comparative efficacy and harms of duloxetine, milnacipran, and pregabalin in fibromyalgia syndrome. J Pain 2010;11:505-21
   PubMed Web of Science ®Google Scholar
• Choy E, Marshall D, Gabriel ZL, et al. A systematic review and mixed treatment comparison of the efficacy of pharmacological treatments for fibromyalgia. Semin Arthritis Rheum 2011;41:335-45 e336
   PubMed Web of Science ®Google Scholar
• Nuesch E, Häuser W, Bernardy K, et al. Comparative efficacy of pharmacological and non-pharmacological interventions in fibromyalgia syndrome: network meta-analysis. Ann Rheum Dis 2013;72:955-62
   PubMed Web of Science ®Google Scholar
• Üçeyler N, Sommer C, Walitt B, et al. Anticonvulsants for fibromyalgia. Cochrane Database Syst Rev 2013;10:CD010782
   PubMed Web of Science ®Google Scholar
• Wiffen PJ, Derry S, Moore RA, et al. Antiepileptic drugs for neuropathic pain and fibromyalgia – an overview of Cochrane reviews. Cochrane Database Syst Rev 2013;11:CD010567
   PubMed Web of Science ®Google Scholar
• Zaccara G, Perucca P, Gangemi PF. The adverse event profile of pregabalin across different disorders: a meta-analysis. Eur J Clin Pharmacol 2012;68:903-12
   PubMed Web of Science ®Google Scholar
• Moore RA, Straube S, Wiffen PJ, et al. Pregabalin for acute and chronic pain in adults. Cochrane Database Syst Rev 2009;3:CD007076
   PubMed Web of Science ®Google Scholar
• Straube S, Derry S, Moore RA, et al. Pregabalin in fibromyalgia: meta-analysis of efficacy and safety from company clinical trial reports. Rheumatology (Oxford) 2010;49:706-15
   PubMed Web of Science ®Google Scholar
• Tzellos TG, Toulis KA, Goulis DG, et al. Gabapentin and pregabalin in the treatment of fibromyalgia: a systematic review and a meta-analysis. J Clin Pharm Ther 2010;35:639-56
   PubMed Web of Science ®Google Scholar
• Roskell NS, Beard SM, Zhao Y, et al. A meta-analysis of pain response in the treatment of fibromyalgia. Pain Pract 2011;11:516-27
   PubMed Web of Science ®Google Scholar
• Derry S, Cording M, Wiffen PJ, et al. Pregabalin for pain in fibromyalgia in adults. Cochrane Database Syst Rev 2016;9:CD011790
   PubMed Web of Science ®Google Scholar
• Metyas S, Ibrahim M, Ortiz EC, et al. Monotherapy versus combination therapy in the treatment of fibromyalgia. Ann Rheum Dis 2013;71(Suppl3):276
   Web of Science ®Google Scholar
• Gilron I, Chaparro LE, Tu D, et al. Combination of pregabalin with duloxetine for fibromyalgia: a randomized controlled trial. Pain 2016;157:1532-40
   PubMed Web of Science ®Google Scholar
• Mease PJ, Farmer MV, Palmer RH, et al. Milnacipran combined with pregabalin in fibromyalgia: a randomized, open-label study evaluating the safety and efficacy of adding milnacipran in patients with incomplete response to pregabalin. Ther Adv Musculoskelet Dis 2013;5:113-26
   PubMedGoogle Scholar
• Calandre EP, Morillas-Arques P, Rodriguez-Lopez CM, et al. Pregabalin augmentation of quetiapine therapy in the treatment of fibromyalgia: an open-label, prospective trial. Pharmacopsychiatry 2007;40:68-71
   PubMed Web of Science ®Google Scholar
• Calandre EP, Morillas-Arques P, Molina-Barea R, et al. Trazodone plus pregabalin combination in the treatment of fibromyalgia: a two-phase, 24-week, open-label uncontrolled study. BMC Musculoskelet Disord 2011;12:95
   PubMed Web of Science ®Google Scholar
• Del Giorno R, Skaper S, Paladini A, et al. Palmitoylethanolamide in fibromyalgia: results from prospective and retrospective observational studies. Pain Ther 2015;4:169-78
   PubMed Web of Science ®Google Scholar
• Ramzy EA. Comparative efficacy of newer antidepressants in combination with pregabalin for fibromyalgia syndrome: a controlled, randomized study. Pain Pract 2017;17:32-40
   PubMed Web of Science ®Google Scholar
• Wolfe F, Smythe HA, Yunus MB, et al. The American College of Rheumatology 1990 criteria for the classification of fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum 1990;33:160-72
   PubMed Web of Science ®Google Scholar
• Yunus MB, Masi AT. Juvenile primary fibromyalgia syndrome. A clinical study of thirty-three patients and matched normal controls. Arthritis Rheum 1985;28:138-45
   PubMed Web of Science ®Google Scholar
• Wolfe F, Clauw DJ, Fitzcharles MA, et al. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken) 2010;62:600-10
   PubMed Web of Science ®Google Scholar
• Arnold LM, Emir B, Murphy TK, et al. Safety profile and tolerability of up to 1 year of pregabalin treatment in 3 open-label extension studies in patients with fibromyalgia. Clin Ther 2012;34:1092-102
   PubMed Web of Science ®Google Scholar
• Ohta H, Oka H, Usui C, et al. An open-label long-term phase III extension trial to evaluate the safety and efficacy of pregabalin in Japanese patients with fibromyalgia. Mod Rheumatol 2013;23:1108-15
   PubMed Web of Science ®Google Scholar
• Nasser K, Kivitz AJ, Maricic MJ, et al. Twice daily versus once nightly dosing of pregabalin for fibromyalgia: a double-blind randomized clinical trial of efficacy and safety. Arthritis Care Res (Hoboken) 2014;66:293-300
   PubMed Web of Science ®Google Scholar
• Hauser W, Bernardy K, Uçeyler N, et al. Treatment of fibromyalgia syndrome with gabapentin and pregabalin – a meta-analysis of randomized controlled trials. Pain 2009;145:69-81
   PubMed Web of Science ®Google Scholar
• Lee YH, Song GG. Comparative efficacy and tolerability of duloxetine, pregabalin, and milnacipran for the treatment of fibromyalgia: a Bayesian network meta-analysis of randomized controlled trials. Rheumatol Int 2016;36:663-72
   PubMed Web of Science ®Google Scholar
• Straube S, Derry S, Moore RA, et al. Pregabalin in fibromyalgia – responder analysis from individual patient data. BMC Musculoskelet Disord 2010;11:150
   PubMed Web of Science ®Google Scholar
• Parsons B, Argoff CE, Clair A, et al. Improvement in pain severity category in clinical trials of pregabalin. J Pain Res 2016;9:779-85
   PubMed Web of Science ®Google Scholar
• Clair A, Emir B. The safety and efficacy of pregabalin for treating subjects with fibromyalgia and moderate or severe baseline widespread pain. Curr Med Res Opin 2016;32:601-9
   PubMed Web of Science ®Google Scholar
• Roth T, Bhadra-Brown P, Pitman VW, et al. Pregabalin improves fibromyalgia-related sleep disturbance. Clin J Pain 2016;32:308-12
   PubMed Web of Science ®Google Scholar
• Peterson BT, Resnick M, Brosnan M, et al. Effect of pregabalin on home sleep and daytime activity patterns in patients with fibromyalgia and sleep maintenance difficulties. Sleep 2011;34:A232
   Web of Science ®Google Scholar
• Russell IJ, Crofford LJ, Leon T, et al. The effects of pregabalin on sleep disturbance symptoms among individuals with fibromyalgia syndrome. Sleep Med 2009;10:604-10
   PubMed Web of Science ®Google Scholar
• Arnold LM, Emir B, Pauer L, et al. Time to improvement of pain and sleep quality in clinical trials of pregabalin for the treatment of fibromyalgia. Pain Med 2015;16:176-85
   PubMed Web of Science ®Google Scholar
• Bushmakin AG, Cappelleri JC, Chandran AB, et al. Evaluation of the fibromyalgia impact questionnaire at baseline as a predictor for time to pain improvement in two clinical trials of pregabalin. Int J Clin Pract 2013;67:52-9
   PubMed Web of Science ®Google Scholar
• Farrar JT, Young JP Jr., LaMoreaux L, et al. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001;94:149-58
   PubMed Web of Science ®Google Scholar
• Parsons B, Emir B, Clair A. Temporal analysis of pain responders and common adverse events: when do these first appear following treatment with pregabalin. J Pain Res 2015;8:303-9
   PubMed Web of Science ®Google Scholar
• Pauer L, Atkinson G, Murphy TK, et al. Long-term maintenance of response across multiple fibromyalgia symptom domains in a randomized withdrawal study of pregabalin. Clin J Pain 2012;28:609-14
   PubMed Web of Science ®Google Scholar
• Argoff CE, Emir B, Whalen E, et al. Pregabalin improves pain scores in patients with fibromyalgia irrespective of comorbid osteoarthritis. Pain Med 2016;17:2100-8
   PubMed Web of Science ®Google Scholar
• Bhadra P, Petersel D. Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of phase III clinical trials. Expert Opin Pharmacother 2010;11:2805-12
   PubMed Web of Science ®Google Scholar
• Arnold LM, Leon T, Whalen E, et al. Relationships among pain and depressive and anxiety symptoms in clinical trials of pregabalin in fibromyalgia. Psychosomatics 2010;51:489-97
   PubMed Web of Science ®Google Scholar
• Argoff CE, Clair A, Emir B, et al. Prior opioid use does not impact the response to pregabalin in patients with fibromyalgia. Clin J Pain 2016;32:555-61
   PubMed Web of Science ®Google Scholar
• Starz T, Wilson H, Robinson J, et al. The effect of baseline tender point severity on treatment outcome in pregabalin clinical trials. J Pain 2010;11:S37
   Google Scholar
• Emir B, Murphy TK, Petersel DL, et al. Treatment response to pregabalin in fibromyalgia pain: effect of patient baseline characteristics. Expert Opin Pharmacother 2010;11:2275-80
   PubMed Web of Science ®Google Scholar
• Silverman SL, Backonja M, Pauer L, et al. Effect of baseline characteristics on the pain response to pregabalin in fibromyalgia patients with comorbid depression. Pain Med 2018;19:419-28
   PubMed Web of Science ®Google Scholar
• Pauer L, Gary A, Petersel DL, et al. The effect of somnolence on pain, function, and sleep responses to pregabalin in patients with fibromyalgia. Arthritis Rheum 2009;60(Suppl10):93
   Google Scholar
• Cabrera J, Emir B, Dills D, et al. Characterizing and understanding body weight patterns in patients treated with pregabalin. Curr Med Res Opin 2012;28:1027-37
   PubMed Web of Science ®Google Scholar
• Arnold LM, Cappelleri JC, Clair A, et al. Interpreting effect sizes and clinical relevance of pharmacological interventions for fibromyalgia. Pain Ther 2013;2:65-71
   PubMedGoogle Scholar