Safety and efficacy of esreboxetine in patients with fibromyalgia: A fourteen-week, randomized, double-blind, placebo-controlled, multicenter clinical trial

Arthritis and Rheumatism

Volumn 64, Issue 7, 2012, Pages 2387-2397

  Arnold, Lesley M ^a   Hirsch, Ian ^b,c   Sanders, Paul ^c   Ellis, Amanda ^c   Hughes, Bernadette ^c  

^a UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

^b ASTRAZENECA   (United Kingdom)

^c PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; REBOXETINE;

ADULT; ARTICLE; BODY WEIGHT; CARDIOVASCULAR SYSTEM; CONSTIPATION; CONTROLLED STUDY; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FIBROMYALGIA; FIBROMYALGIA IMPACT QUESTIONNAIRE; GLOBAL FATIGUE INDEX; HEADACHE; HEART PALPITATION; HOT FLUSH; HUMAN; HYPERHIDROSIS; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PAIN ASSESSMENT; PATIENT COMPLIANCE; PATIENT GLOBAL IMPRESSION OF CHANGE SCALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SHORT FORM 36; SIDE EFFECT; XEROSTOMIA;

ADULT; AGED; DOUBLE-BLIND METHOD; FATIGUE; FEMALE; FIBROMYALGIA; HUMANS; MALE; MIDDLE AGED; MORPHOLINES; PAIN; PAIN MEASUREMENT; PATIENT SATISFACTION; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 84863210713     PISSN: 00043591     EISSN: 15290131     Source Type: Journal    
DOI: 10.1002/art.34390     Document Type: Article

References (44)

1. Wolfe F, Ross K, Anderson J, Russell IJ, Hebert L. The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum 1995;38:19-28.
2. White K, Harth M. Classification, epidemiology, and natural history of fibromyalgia. Curr Pain Headache Rep 2001;5:320-9.
3. 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. (Pubitemid 20098653)
4. Bernard AL, Prince A, Edsall P. Quality of life issues for fibromyalgia patients. Arthritis Care Res 2000;13:42-50.
5. Arnold LM, Crofford LJ, Mease PJ, Burgess SM, Palmer SC, Abetz L, et al. Patient perspectives on the impact of fibromyalgia. Patient Educ Couns 2008;73:114-20.
6. Arnold LM. Biology and therapy of fibromyalgia: new therapies in fibromyalgia. Arthritis Res Ther 2006;8:212.
7. Clauw DJ. Pharmacotherapy for patients with fibromyalgia. J Clin Psychiatry 2008;69 Suppl 2:25-9.
8. Staud R. Evidence of involvement of central neural mechanisms in generating fibromyalgia pain. Curr Rheumatol Rep 2002;4:299-305.
9. Harris RE, Clauw DJ. Newer treatments for fibromyalgia syndrome. Ther Clin Risk Manag 2008;4:1331-42.
10. Hauser W, Petzke F, Sommer C. Comparative efficacy and harms of duloxetine, milnacipran, and pregabalin in fibromyalgia syndrome. J Pain 2010;11:505-21.
11. Arnold LM, Rosen A, Pritchett YL, D'Souza DN, Goldstein DJ, Iyengar S, et al. A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder. Pain 2005;119:5-15. (Pubitemid 41752960)
12. Arnold LM, Lu Y, Crofford LJ, Wohlreich M, Detke MJ, Iyengar S, et al. A double-blind, multicenter trial comparing duloxetine with placebo in the treatment of fibromyalgia patients with or without major depressive disorder. Arthritis Rheum 2004;50:2974-84. (Pubitemid 39209537)
13. Arnold LM, Clauw DJ, Wohlreich M, 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.
14. Arnold LM, Clauw D, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Flexible dosed duloxetine in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled trial. J Rheumatol 2010;37:2578-86.
15. Arnold LM, Gendreau RM, Palmer RH, Gendreau JF, Wang Y. Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2010;62:2745-56.
16. Ormseth MJ, Eyler AE, Hammonds CL, Boomershine CS. Milnacipran for the management of fibromyalgia syndrome. J Pain Res 2010;3:15-24.
17. Geisser ME, Palmer RH, Gendreau RM, Wang Y, Clauw DJ. A pooled analysis of two randomized, double-blind, placebo-controlled trials of milnacipran monotherapy in the treatment of fibromyalgia. Pain Pract 2011;11:120-31.
18. Branco JC, Zachrisson O, Perrot S, Mainguy Y, on behalf of the Multinational Coordinator Study Group. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia. J Rheumatol 2010;37:851-9.
19. Arnold LM, Keck PE Jr, Welge JA. Antidepressant treatment of fibromyalgia: a meta-analysis and review. Psychosomatics 2000;41:104-13. (Pubitemid 30159888)
20. O'Malley PG, Balden E, Tomkins G, Santoro J, Kroenke K, Jackson JL. Treatment of fibromyalgia with antidepressants. J Gen Intern Med 2000;15:659-66.
21. Millan MJ. Descending control of pain. Prog Neurobiol 2002;66:355-474. (Pubitemid 34606906)
22. Anderberg UM, Marteinsdottir I, von Knorring L. Citalopram in patients with fibromyalgia: a randomized, double-blind, placebo-controlled study. Eur J Pain 2000;4:27-35. (Pubitemid 30230793)
23. Norregaard J, Volkmann H, Danneskiold-Samsoe B. A randomized controlled trial of citalopram in the treatment of fibromyalgia. Pain 1995;61:445-9.
24. Wolfe F, Cathey MA, Hawley DJ. A double-blind placebo controlled trial of fluoxetine in fibromyalgia. Scand J Rheumatol 1994;23:255-9. (Pubitemid 24334031)
25. Goldenberg D, Mayskiy M, Mossey C, Ruthazer R, Schmid C. A randomized, double-blind crossover trial of fluoxetine and amitriptyline in the treatment of fibromyalgia. Arthritis Rheum 1996;39:1852-9. (Pubitemid 26378576)
26. Arnold LM, Hess EV, Hudson JI, Welge JA, Berno SE, Keck PE Jr. A randomized, placebo-controlled, double-blind, flexible-dose study of fluoxetine in the treatment of women with fibromyalgia. Am J Med 2002;112:191-7.
27. Bohn LM, Xu F, Gainetdinov RR, Caron MG. Potentiated opioid analgesia in norepinephrine transporter knock-out mice. J Neurosci 2000;20:9040-5. (Pubitemid 32042905)
28. Fishbain DA, Cutler R, Rosomoff HL, Rosomoff RS. Evidence-based data from animal and human experimental studies on pain relief with antidepressants: a structured review. Pain Med 2000;1:310-6.
29. Krell HV, Leuchter AF, Cook IA, Abrams M. Evaluation of reboxetine, a noradrenergic antidepressant, for the treatment of fibromyalgia and chronic low back pain. Psychosomatics 2005;46:379-84. (Pubitemid 46173196)
30. Arnold LM, Chatamra K, Hirsch I, Stoker M. Safety and efficacy of esreboxetine in patients with fibromyalgia: an 8-week, multicenter, randomized, double-blind, placebo-controlled study. Clin Ther 2010;32:1618-32.
31. Melzack R. The short-form McGill Pain Questionnaire. Pain 1987;30:191-7. (Pubitemid 18029372)
32. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structureddiagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998;59 Suppl 20:22-33. (Pubitemid 29001829)
33. Jensen MP, Karoly P. Self-report scales and procedures for assessing pain in adults. In: Turk DC, Melzack R, editors. Handbook of pain assessment. New York (NY): Guilford; 1992. p. 135-51.
34. Burckhardt CS, Clark SR, Bennett RM. The Fibromyalgia Impact Questionnaire: development and validation. J Rheumatol 1991;18:728-33.
35. Guy W. Clinical global impressions: ECDEU assessment manual for psychopharmacology. Rockville (MD): US Department of Health, Education, and Welfare; 1976.
36. Ware JE, Snow KK, Kosinski M. SF-36 Health Survey: manual and interpretation guide. Boston: New England Medical Center, The Health Institute; 1993.
37. Belza BL, Henke CJ, Yelin EH, Epstein WV, Gilliss CL. Correlates of fatigue in older adults with rheumatoid arthritis. Nurs Res 1993;42:93-9.
38. Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika 1988;75:800-2.
39. Mallinckrodt CH, Clark WS, David SR. Accounting for dropout bias using mixed-effects models. J Biopharm Stat 2001;11:9-21. (Pubitemid 32642825)
40. Little RC, Stroup WW, Freund RJ. SAS for linear models. 4th ed. Cary (NC): SAS Institute; 2002.
41. Stokes ME, Davis CS, Koch GG. Categorical data analysis using the SAS system. 2nd ed. Cary (NC): SAS Institute; 2000.
42. Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001;94:149-58. (Pubitemid 33016608)
43. Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB. Minimal clinically important difference in the Fibromyalgia Impact Questionnaire. J Rheumatol 2009;36:1304-11.
44. Denolle T, Pellizzoni C, Jannuzzo MG, Poggesi I. Hemodynamic effects of reboxetine in healthy male volunteers. Clin Pharmacol Ther 1999;66:282-7. (Pubitemid 29451760)