The Journal of Pain
Volume 11, Issue 6 , Pages 505-521 , June 2010

Comparative Efficacy and Harms of Duloxetine, Milnacipran, and Pregabalin in Fibromyalgia Syndrome

  • Winfried Häuser

      Affiliations

    • Department of Internal Medicine I, Klinikum Saarbrücken, D-66119 Saarbrücken, Germany
    • Department of Psychosomatic Medicine, Technische Universität München, D-81675 München, Germany
    • Corresponding Author InformationAddress reprint requests to Winfried Häuser, M.D., Klinikum Saarbrücken gGmbH, Winterberg 1, D-66119 Saarbrücken, Germany.
    • ,
  • Frank Petzke

      Affiliations

    • Department of Anesthesiology and Postoperative Intensive Care Medicine, University of Cologne, D-50924 Cologne, Germany
    • ,
  • Claudia Sommer

      Affiliations

    • Department of Neurology, University of Würzburg, D-97080 Würzburg, Germany

References 

  1. Arnold LM, Bradley LA, Clauw DJ, Glass JM, Goldenberg DL. Multidisciplinary care and stepwise treatment for fibromyalgia. J Clin Psychiatry. 2009;69:e35
  2. 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;50:2974–2984
  3. 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 with out major depressive disorder. Pain. 2005;119:5–15
  4. Arnold LM, Russell IJ, Diri EW, Duan WR, Young JP, Sharma U, et al. A 14-week, randomized, double-blinded, placebo-controlled monotherapy trial of pregabalin in patients with fibromyalgia. J Pain. 2008;9:792–805
  5. 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
  6. Bucher HC, Guyatt GH, Griffith LE, Walter SD. The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol. 1997;50:683–691
  7. Busch AJ, Schachter CL, Overend TJ, Peloso PM, Barber KA. Exercise for fibromyalgia: A systematic review. J Rheumatol. 2008;35:1130–1144
  8. Carville SF, Arendt-Nielsen S, Bliddal H, Blotman F, Branco JC, Buskila D, et al. EULAR evidence based recommendations for the management of fibromyalgia syndrome. Ann Rheum Dis. 2008;67:536–541
  9. Center for drug evaluation and research. Application number 22-148. Statistical reviews. Accessed at http://www.fda.gov/cder/foi/nda/2008/022148s000StatR.pdf Accessed on March 31, 2009
  10. Center for Drug Evaluation and Research. Application number 22-148. Medical reviews. http://www.fda.gov/cder/foi/nda/2008/022148s000MedR_P1/2/3.pdf Accessed on March 31, 2009
  11. Center for Drug Evaluation and Research. Application number 22-256. Statistical reviews. Accessed at http://www.fda.gov/cder/foi/nda/2009/022256s000StatR.pdf Accessed on March 31, 2009
  12. Center for Drug Evaluation and Research. Application number 22-256. Medical review. http://www.fda.gov/cder/foi/nda/2009/022256s000MedRP1/2/3.pdf Accessed on March 31, 2009
  13. Chappell AS, Bradley LA, Wiltse C, Detke MJ, D'Souza DN, Späth M. A six-month double-blind, placebo controlled, randomised clinical trial of duloxetine for the treatment of fibromyalgia. Int J General Med. 2008;1:91–102
  14. Chou R, Carson S, Chan BK. Gabapentin versus tricyclic antidepressants for diabetic neuropathy and post-herpetic neuralgia: Discrepancies between direct and indirect meta-analyses of randomized controlled trials. J Gen Intern Med. 2009;24:178–188
  15. 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;28:1035–1044
  16. Clauw DJ, Mease P, Palmer RH, Gendreau RM, Wang Y. Milnacipran for the treatment of fibromyalgia in adults: A 15-week, multicenter, randomized, double- blind, placebo-controlled, multiple-dose clinical trial. Clin Ther. 2008;30:1988–2004
  17. Cohen J. Statistical Power Analysis for the Behavoral Sciences. (1st ed.). Hillsdale, NJ: Lawrence Erlbaum Associates; 1988;
  18. Crofford LJ, Mease PJ, Simpson SL, Young JP, 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;136:419–431
  19. 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. Arthritis Rheum. 2005;52:1264–1273
  20. Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ. 1997;315:629–634
  21. Eich W, Häuser W, Friedel E, Klement A, Herrmann M, Petzke F, et al. [Definition, classification and diagnosis of fibromyalgia syndrome]. Z Rheumatol. 2008;67:665–676(German)
  22. Engels EA, Schmid CH, Terrin N, Olkin I, Lau J. Heterogeneity and statistical significance in meta-analysis: An empirical study of 125 meta-analyses. Stat Med. 2000;19:1707–1728
  23. FDA Center for Drug Evaluation and Research. Approval duloxetine (cymbalta). June 13, 2008. Accessed at http://www.fda.gov/cder/foi/appletter/2008/022148s000ltr.pdf, on April 10, 2009
  24. FDA Center for Drug Evaluation and Research. Approval milnacipran (savella). January 13, 2009. Accesed at http://www.fda.gov/cder/foi/appletter/2009/022256ltr.pdf, on April 10, 2009
  25. Fietta P, Fietta P, Manganelli P. Fibromyalgia and psychiatric disorders. Acta Biomed. 2007;78:88–95
  26. Forest Laboratories, Inc. and Cypress Bioscience Announce Revised Timing for Commercial Availability of Savella.™ Accessed http://www.cypressbio.com/news/20090306.pdf, March 31.2009
  27. Gartlehner G, Hansen RA, Nissman D, Lohr KN, Carey TS. A simple and valid tool distinguished efficacy from effectiveness studies. J Clin Epidemiol. 2006;59:1040–1048
  28. Gartlehner G, Thieda P, Hansen RA, Morgan LC, Shumate JA, Nissman DB. Inadequate reporting of trials compromises the applicability of systematic reviews. Int J Technol Assess Health Care. 2009;25:323–330
  29. Gran JT. The epidemiology of chronic generalized musculoskeletal pain. Best Practice Res Clin Rheumatol. 2003;17:547–561
  30. Häuser W, Bernardy K, Arnold B, Offenbächer M, Schiltenwolf M. Efficacy of multicomponent treatment in fibromyalgia syndrome: A meta-analysis of randomized controlled clinical trials. Arthritis Rheum. 2009;61:216–224
  31. Häuser W, Bernardy K, Üçeyler N, Sommer C. Treatment of fibromyalgia syndrome with antidepressants: A meta-analysis. JAMA. 2009;30:198–209
  32. Häuser W, Bernardy K, Üçeyler N, Sommer C. Treatment of fibromyalgia syndrome with gabapentin and pregabalin – a metaanalysis. Pain. 2009;145:69–81
  33. Häuser W, Eich W, Herrmann M, Nutzinger DO, Schiltenwolf M, Henningsen P. Fibromyalgia syndrome: Classification, diagnosis, and treatment. Dtsch Arztebl Int. 2009;106:383–391
  34. Häuser W, Zimmer C, Felde E, Köllner V. What are the key symptoms of fibromyalgia syndrome? Results of a survey of the German Fibromyalgia Association. Schmerz. 2008;22:176–183(German)
  35. Henningsen P, Zimmermann T, Sattel H. Medically unexplained physical symptoms, anxiety, and depression: A meta-analytic review. Psychosom Med. 2003;65:528–533
  36. Higgins JPT, Green S (eds): Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [updated September 2008]: The Cochrane Collaboration, 2008. Available from, www.cochrane-handbook.org
  37. Hopewell S, McDonald S, Clarke M, Egger M. Grey literature in meta-analyses of randomized trials of health care interventions. Cochrane Database Syst Rev. 18;MR000010. 2007;
  38. Ioannidis JPA. Why most published research findings are false. PLoS Med. 2005;2:e124
  39. Katz RS, Heard AR, Mills M, Leavitt F. The prevalence and clinical impact of reported cognitive difficulties (Fibrofog) in patients with rheumatic disease with and without fibromyalgia. J Clin Rheumatol. 2004;10:53–58
  40. Laird NM, Mostellier F. Some statistical methods for combining experimental results. Int J Technol Assess Health Care. 1990;6:5–30
  41. Langhorst J, Musial F, Klose P, Häuser W. Efficacy of hydrotherapy in fibromyalgia syndrome–a meta-analysis of randomized controlled clinical trials. Rheumatology (Oxford). 2009;48:1155–1159
  42. Lyseng-Williamson KA, Siddiqui MA. Pregabalin: A review of its use in fibromyalgia. Drugs. 2008;68:2205–2223
  43. Mease PJ, Arnold LM, Crofford LJ, Williams DA, Russell IJ, Humphrey L, et al. Identifying the clinical domains of fibromyalgia: Contributions from clinician and patient Delphi exercises. Arthritis Rheum. 2008;59:952–960
  44. Mease PJ, Clauw DJ, Gendreau RM, Rao SG, Kranzler J, Chen W, et al. The efficacy and safety of milnacipran for treatment of fibromyalgia. A randomized, double-blind, placebo-controlled trial. J Rheumatol. 2009;36:398–409
  45. Mease PJ, Russell IJ, Arnold LM, Florian H, Young A: A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. J Rheumatol 35:502–514, 2008
  46. Mease PJ, Russell IJ, Kajdasz DK, Wiltse CG, Detke MJ, Wohlreich MM, et al. Long-term safety, tolerability and efficacy of duloxetine in the treat- ment of fibromyalgia. Semin Arthritis Rheum epub. Jan 17, 2009;
  47. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the quality of reports of meta-analyses of randomised controlled trials: The QUOROM statement. Quality of Reporting of Meta-analyses. Lancet. 1999;354:1896–1900
  48. National Institutes for Health. http://clinicaltrials.gov/ct2/results?term=duloxetine(orpregabalineormilnacipran)+and+fibromyalgia. Accessed on March 31, 2009
  49. Page RL, Cantu M, Lindenfeld J, Hergott LJ, Lowes BD. Possible heart failure exacerbation associated with pregabalin: Case discussion and literature review. J Cardiovasc Med. 2008;9:922–955
  50. Pfizer. Protocol No. A0081100: A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia. Accessed at http://pdf.clinicalstudyresults.org/documents/company-study_4636_0.pdf, on March 31, 2009
  51. Pfizer. Protocol No. A0081078: A 12-Week Open-Label Safety Trial of Pregabalin in Patients with Fibromyalgia. Accessed at http://pdf.clinicalstudyresults.org/documents/company-study_3172_0.pdf, on March 31, 2009
  52. Pfizer. Protocol No. A0081057: A Long-term, Open-label, Safety Trial of Pregabalin in Patients with Fibromyalgia. Accessed at http://pdf.clinicalstudyresults.org/documents/company-study_2886_0.pdf on March 31, 2009
  53. Pfizer. Protocol No. A0081101: A 12 Week, Open-label, Safety Trial Of Pregabalin In Patients With Fibromyalgia. Acessed at http://pdf.clinicalstudyresults.org/documents/company-study_4637_0.pdf, on March 31, 2009
  54. Pharmaceutical Research and Manufacturers of America (PhRMA). Accessed at http://www.clinicalstudyresults.org/home/ on March 31, 2009
  55. Picavet HS, Hoeymans N. Health related quality of life in multiple musculoskeletal diseases: SF-36 and EQ-5D in the DMC3 study. Ann Rheum Dis. 2004;63:723–729
  56. Russell IJ, Mease PJ, Smith TR, Kajdasz DK, Wohlreich MM, Detke MJ, et al. Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with or without major depressive disorder: Results from a 6- month, randomized, double-blind, placebo-controlled, fixed-dose trial. Pain. 2008;136:432–444
  57. The Nordic Cochrane Centre . Review Manager (RevMan) [Computer program]. Version 5.0 for Windows. Copenhagen: The Cochrane Collaboration; 2009;
  58. US Food and Drug Administration. Prescribing information duloxetine. Accessed at http://www.fda.gov/cder/foi/label/2009/021427s021s027s028lbl.pdf. Accessed on March 31, 2009
  59. US Food and Drug Administration. Prescribing information milnacipran. Accessed at http://www.fda.gov/cder/foi/label/2009/022256lbl.pdf. Accessed on March 31, 2009
  60. US Food and Drug Administration. Index to drug specific informations. Accessed at http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm. Accessed on March 31, 2009
  61. US Food and Drug Administration. Prescribing information pregabalin. Accessed at http://www.fda.gov/cder/foi/label/2007/021446s010lbl.pdf. Accessed on March 31, 2009
  62. US Food and Drug Administration. FDA Approves First Drug for Treating Fibromyalgia. http://www.fda.gov/bbs/topics/NEWS/2007/NEW01656.html. Accessed on April 10, 2009
  63. US Food and Drug Administration. Suicidal Behavior and Ideation and Antiepileptic Drugs. http://www.fda.gov/cder/drug/infopage/antiepileptics/default.htm. Accessed March 31, 2009
  64. Vaishnavi SN, Nemeroff CB, Plott SJ, Rao SG, Kranzler J, Owens MJ. Milnacipran: A comparative analysis of human monoamine uptake and transporter binding affinity. Biol Psychiatry. 2004;55:320–322
  65. vanTulder MW , Furlan A, Bombardier C, Bouter L. Updated method guidelines for systematic reviews in the Cochrane Collaboration Back Review Group. Spine. 2003;28:1290–1299
  66. Vitton O, Gendreau M, Gendreau J, Kranzler J, Rao SG. A double-blind placebo- controlled trial of milnacipran in the treatment of fibromyalgia. Hum Psychopharma Col. 2004;19(Suppl 1):S27–35
  67. 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;33:160–172
  68. Wohlreich MM, Acharya N, Strombom I, Kuritzky L, Robinson M, Heinloth AN, et al. Answers to the most common questions about the hepatic safety profile of duloxetine. Postgrad Med. 2008;120:111–118
  69. Wood PB, Holman AJ, Jones KD. Novel pharmacotherapy for fibromyalgia. Expert Opin Investig Drugs. 2007;16:829–841

PII: S1526-5900(10)00017-9

doi: 10.1016/j.jpain.2010.01.002

The Journal of Pain
Volume 11, Issue 6 , Pages 505-521 , June 2010

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