An open-label long-term phase III extension trial to evaluate the safety and efficacy of pregabalin in Japanese patients with fibromyalgia

References

• Ablin JN, Cohen H, Buskila D. Mechanisms of disease: genetics of fibromyalgia. Nat Clin Pract Rheumatol. 2006; 2(12): 671–678.
   PubMedGoogle Scholar
• Bradley LA. Pathophysiology of fibromyalgia. Am J Med. 2009; 122(12 suppl):S22–S30.
   Google Scholar
• Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, et al. The American College of Rheumatology 1990 criteria for the classification of fibromyalgia. Report of the Multicenter Criteria Committee. Arthr Rheum. 1990; 33(2): 160–172.
   PubMed Web of Science ®Google Scholar
• Wolfe F, Clauw DJ, Fitzcharles M-A, Goldenberg DL, Katz RS, Mease P, et al. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthr Care Res (Hoboken).. 2010; 62(5): 600–610.
   PubMed Web of Science ®Google Scholar
• Usui C, Hatta K, Aratani S, Yagishita N, Nishioka K, Kanazawa T, et al. The Japanese version of the 2010 American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and the fibromyalgia symptom scale: reliability and validity. Mod Rheumatol. 2012; 22(1): 40–44.
   PubMedGoogle Scholar
• Hoffman DL, Dukes EM. The health status burden of people with fibromyalgia: a review of studies that assessed health status with the SF-36 or the SF-12. Int J Clin Pract. 2008; 62(1): 115–126.
   PubMedGoogle Scholar
• Schaefer C, Chandran A, Hufstader M, Baik R, McNett M, Goldenberg D, 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
• Winkelmann A, Perrot S, Schaefer C, Ryan K, Chandran A, Sadosky A, et al. Impact of fibromyalgia severity on health economic costs: results from a European cross-sectional study. Appl Health Econ Health Policy. 2011; 9(2): 125–136.
   PubMedGoogle Scholar
• Matsumoto M. Epidemiology of fibromyalgia [in Japanese]. Pharma Medica. 2006; 24(6): 35–39.
   Google Scholar
• Nishioka K. Research platform for fibromyalgia in Japan. Arthritis Res Ther. 2012; 14(suppl 1):O5
   Google Scholar
• Mease PJ, Clauw DJ, Arnold LM, Goldenberg DL, Witter J, Williams DA, et al. Fibromyalgia syndrome. J Rheumatol. 2005; 32(11): 2270–2277.
   PubMedGoogle Scholar
• Bennett RM. Emerging concepts in the neurobiology of chronic pain: evidence of abnormal sensory processing in fibromyalgia. Mayo Clin Proc. 1999; 74(4): 385–398.
   PubMedGoogle Scholar
• Field MJ, Cox PJ, Stott E, Melrose H, Offord J, Su TZ, et al. Identification of the α2-δ-1 subunit of voltage-dependent calcium channels as a molecular target for pain mediating the analgesic actions of pregabalin. Proc Natl Acad Sci USA. 2006; 103(46): 17537–17542.
   PubMedGoogle Scholar
• Arnold LM, Russell IJ, Diri EW, Duan WR, Young JP Jr, Sharma U, et al. A 14-week, randomized, double-blinded, placebo-controlled monotherapy trial of pregabalin in patients with fibromyalgia. J Pain. 2008; 9(9): 792–805.
   PubMed Web of Science ®Google Scholar
• Crofford LJ, Rowbotham MC, Mease PJ, Russell IJ, Dworkin RH, Corbin AE, et al. Pregabalin 1008–105 Study Group. Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthr Rheum. 2005; 52(4): 1264–1273.
   PubMed Web of Science ®Google Scholar
• Mease PJ, Russell IJ, Arnold LM, Florian H, Young JP Jr, Martin SA, et al. A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. J Rheumatol. 2008; 35(3): 502–514.
   PubMed Web of Science ®Google Scholar
• Pauer L, Winkelmann A, Arsenault P, Jespersen A, Whelan L, Atkinson G, A0081100 Investigators 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(12): 2643–2652.
   PubMedGoogle Scholar
• Ohta H, Oka H, Usui C, Ohkura M, Suzuki M, Nishioka K. A randomized, double-blind, multicenter, placebo-controlled phase III trial to evaluate the efficacy and safety of pregabalin in Japanese patients with fibromyalgia. Arthr Res Ther. 2012; 14(5): R217
   PubMedGoogle Scholar
• Hays RD, Stewart AL. Stewart AL, Ware JE Jr. Sleep measures. Measuring functioning and well-being. Durham: Duke University Press; 1992. p. 235–239.
   Google Scholar
• Burckhardt CS, Clark SR, Bennett RM. The fibromyalgia impact questionnaire: development and validation. J Rheumatol. 1991; 18(5): 728–733.
   PubMedGoogle Scholar
• Osada K, Oka H, Isomura T, Nakamura I, Tominaga K, Takahashi S, et al. Development of the Japanese version of the Fibromyalgia Impact Questionnaire (JFIQ): psychometric assessments of reliability and validity. Int J Rheum Dis. 2011; 14(1): 74–80.
   PubMedGoogle Scholar
• Crofford LJ, Mease PJ, Simpson SL, Young JP Jr, Martin SA, Haig GM, 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(3): 419–431.
   PubMedGoogle Scholar
• Satoh J, Yagihashi S, Baba M, Suzuki M, Arakawa A, Yoshiyama T. Efficacy and safety evaluation of pregabalin treatment over 52 weeks in patients with diabetic neuropathic pain extended after a double-blind placebo-controlled trial. J Diabetes Investig. 2011; 2(6): 457–463.
   PubMedGoogle Scholar
• Satoh J, Yagihashi S, Baba M, Suzuki M, Arakawa A, Yoshiyama T, et al. Efficacy and safety of pregabalin for treating neuropathic pain associated with diabetic peripheral neuropathy: a 14 week, randomized, double-blind, placebo-controlled trial. Diabet Med. 2011; 28(1): 109–116.
   PubMedGoogle Scholar
• Ogawa S, Suzuki M, Arakawa A, Yoshiyama T. Long-term efficacy and safety of pregabalin in patients with postherpetic neuralgia: results of a 52-week, open-label, flexible-dose study [in Japanese]. Masui. 2010; 59(8): 961–970.
   PubMedGoogle Scholar
• Ogawa S, Satoh J, Arakawa A, Yoshiyama T, Suzuki M. Pregabalin treatment for peripheral neuropathic pain—a review of safety data from randomized controlled trials conducted in Japan and in the West. Drug Saf. 2012; 35(10): 793–806.
   PubMedGoogle Scholar