An open-label, long-term, phase III extension trial of duloxetine in Japanese patients with fibromyalgia

References

• Japan College of Fibromyalgia Investigation, ed. Guidelines for diagnosis and treatment of fibromyalgia 2013. Japan: Japan Medical Journal Co. Ltd; 2013.
   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. Arthritis Rheum. 1990;33:160–72.
   PubMed Web of Science ®Google Scholar
• Wolfe F, Ross K, Anderson J, Russell I, Hebert L. The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum. 1995;38:19–28.
   PubMed Web of Science ®Google Scholar
• Clauw DJ, ed. Fibromyalgia–the evolution of new treatment strategies for improving patient care. Am J Med. 2009;122(12)(Suppl. A):S1–S58.
   Google Scholar
• Bennett RM, Jones J, Turk DC, Russell IJ, Matallana L. An internet survey of 2,596 people with fibromyalgia. BMC Musculoskelet Disord. 2007;8:27.
   PubMed Web of Science ®Google Scholar
• Nakamura I, Nishioka K, Usui C, Osada K, Ichibayashi H, Ishida M, et al. An epidemiologic internet survey of fibromyalgia and chronic pain in Japan. Arthritis Care Res. 2014; 66:1093–101.
   PubMed Web of Science ®Google Scholar
• Da Costa D, Dobkin PL, Fitzcharles MA, Fortin PR, Beaulieu A, Zummer M, et al. Determinants of health status in fibromyalgia: a comparative study with systemic lupus erythematosus. J Rheumatol. 2000;27:365–72.
   PubMed Web of Science ®Google Scholar
• Matsumoto Y, Maeda S, Tamakoshi A, Nishioka K. A nationwide epidemiological survey for patients with fibromyalgia in Japan. [In Japanese]. Clin Rheumatol. 2006;18:87–92.
   Google Scholar
• Arnold LM, Clauw DJ, Wohlreich MM, Wang F, Ahl J, Gaynor PJ, et al. Efficacy of duloxetine in patients with fibromyalgia: pooled analysis of 4 placebo-controlled clinical trials. Prim Care Companion J Clin Psychiatry. 2009;11:237–44.
   PubMedGoogle Scholar
• Choy EH, Mease PJ, Kajdasz DK, Wohlreich MM, Crits-Christoph P, Walker DJ, et al. Safety and tolerability of duloxetine in the treatment of patients with fibromyalgia: pooled analysis of data from five clinical trials. Clin Rheumatol. 2009;28:1035–44.
   PubMed Web of Science ®Google Scholar
• Murakami M, Osada K, Mizuno H, Ochiai T, Alev L, Nishioka K. A randomized, double-blind, placebo-controlled phase III trial of duloxetine in Japanese fibromyalgia patients. Arthritis Res Ther. 2015;17:224.
   PubMed Web of Science ®Google Scholar
• Chappell AS, Littlejohn G, Kajdasz DK, Scheinberg M, D’Souza DN, Moldofsky H. A 1-year safety and efficacy study of duloxetine in patients with fibromyalgia. Clin J Pain. 2009;25:365–75.
   PubMed Web of Science ®Google Scholar
• Mease PJ, Russell IJ, Kajdasz DK, Wiltse CG, Detke MJ, Wohlreich MM, et al. Long-term safety, tolerability, and efficacy of duloxetine in the treatment of fibromyalgia. Semin Arthritis Rheum. 2010;39:454–64.
   PubMed Web of Science ®Google Scholar
• Yasuda H, Hotta N, Kasuga M, Kashigawi A, Kawamori R, Yamada T, et al. Efficacy and safety of 40 mg or 60 mg duloxetine in Japanese adults with diabetic neuropathic pain: results from a randomized, 52-week, open-label study. J Diabetes Investig. 2016;7:100–8.
   PubMed Web of Science ®Google Scholar
• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore. 1994;23:129–38.
   PubMedGoogle Scholar
• Uki J, Mendoza T, Cleeland CS, Nakamura Y, Takeda F. A brief cancer pain assessment tool in Japanese: the utility of the Japanese Brief Pain Inventory-BPI-J. J Pain Symptom Manage 1998;16:364–73.
   PubMed Web of Science ®Google Scholar
• Hata T, Kita T, Itoh E, Oyama R, and Kawabata A. Mechanism of the analgesic effect of neurotropin. Jpn J Pharmacol. 1988;48:165–73.
   PubMedGoogle Scholar
• Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, et al. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011;168:1266–77.
   PubMed Web of Science ®Google Scholar
• Guy W. ECDEU Assessment Manual for Psychopharmacology, Revised 1976. Rockville, MD: US Department of Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, National Institute of Mental Health, Psychopharmacology Research Branch, Division of Extramural Research Programs; 1976.
   Google 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;14:74–80.
   PubMed Web of Science ®Google Scholar
• Burckhardt CS, Clark SR, Bennett RM. The Fibromyalgia Impact Questionnaire: development and validation. J Rheumatol. 1991;18:728–33.
   PubMed Web of Science ®Google Scholar
• Fukuhara S, Bito S, Green J, Hsiao A, Kurokawa K. Translation, adaptation, and validation of the SF-36 Health Survey for use in Japan. J Clin Epidemiol. 1998;51:1037–44.
   PubMed Web of Science ®Google Scholar
• Fukuhara S, Ware JE, Kosinski M, Wada S, and Gandek B. Psychometric and clinical tests of validity of the Japanese SF-36 Health Survey. J Clin Epidemiol. 1998;51:1045–53.
   PubMed Web of Science ®Google Scholar
• Beck AT, Steer RA, Brown GK. Manual for the Beck Depression Inventory-2. San Antonio, TX: Psychological Corporation; 1996.
   Google Scholar
• Kojima M, Furukawa TA, Takahashi H, Kawai M, Nagaya T, Tokudome S. Cross-cultural validation of the Beck Depression Inventory-II in Japan. Psychiatry Res. 2002;110:291–9.
   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;22:40–4.
   PubMed Web of Science ®Google Scholar
• Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, et al. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res. 2010;62:600–10.
   PubMed Web of Science ®Google Scholar
• Higuchi T. Clinical evaluation of duloxetine in the treatment of major depressive disorder—long-term treatment study in major depressive disorder. Jpn J Clin Psychopharmacol. 2009;12:1579–93.
   Google Scholar