Durability of therapeutic response to milnacipran treatment for fibromyalgia. Results of a randomized, double-blind, monotherapy 6-month extension study

Pain Medicine

Volumn 11, Issue 2, 2010, Pages 180-194

  Goldenberg, Don L ^a   Clauw, Daniel J ^b   Palmer, Robert H ^c   Mease, Philip ^d   Chen, Wei ^c   Gendreau, R Michael ^e  

^a Department of Medicine   (United Kingdom)

^b UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^c FOREST RESEARCH INSTITUTE   (United States)

^d Seattle Rhumatology Associates   (United States)

^e Cypress Bioscience Inc   (United States)

Author keywords

Analgesic; Fibromyalgia; Long term; Milnacipran; Pain; Serotonin norepinephrine reuptake inhibitor

Indexed keywords

MILNACIPRAN; PLACEBO;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIASTOLIC BLOOD PRESSURE; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FIBROMYALGIA; FIBROMYALGIA IMPACT QUESTIONNAIRE; HEART RATE; HUMAN; HYPERHIDROSIS; HYPERTENSION; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; MIGRAINE; MONOTHERAPY; MULTICENTER STUDY; NAUSEA; OUTCOME ASSESSMENT; PAIN ASSESSMENT; PATIENT GLOBAL IMPRESSION OF CHANGE; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SIDE EFFECT; SINUSITIS; SYSTOLIC BLOOD PRESSURE; THORAX PAIN; TREATMENT DURATION; VISUAL ANALOG SCALE;

EID: 75249097956     PISSN: 15262375     EISSN: 15264637     Source Type: Journal    
DOI: 10.1111/j.1526-4637.2009.00755.x     Document Type: Article

References (42)

1. Macfarlane GJ. Generalized pain, fibromyalgia and regional pain: An epidemiological view. Baillieres Best Pract Res Clin Rheumatol 1999, 13:403-14.
2. 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.
3. Abeles AM, Pillinger MH, Solitar BM, Abeles M. Narrative review: The pathophysiology of fibromyalgia. Ann Intern Med 2007, 146:726-34.
4. Williams DA, Gracely RH. Biology and therapy of fibromyalgia. Functional magnetic resonance imaging findings in fibromyalgia. Arthritis Res Ther 2006, 8:224.
5. Wolfe F, Smythe HA, Yunus MB. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum 1990, 33:160-72.
6. Mease PJ, Arnold LM, Crofford LJ. Identifying the clinical domains of fibromyalgia: Contributions from clinician and patient Delphi exercises. Arthritis Rheum 2008, 59:952-60.
7. Boonen A, van den Heuvel R, van Tubergen A. Large differences in cost of illness and wellbeing between patients with fibromyalgia, chronic low back pain, or ankylosing spondylitis. Ann Rheum Dis 2005, 64:396-402.
8. Prodinger B, Cieza A, Williams DA. Measuring health in patients with fibromyalgia: Content comparison of questionnaires based on the International Classification of Functioning, Disability and Health. Arthritis Rheum 2008, 59:650-8.
9. Weir PT, Harlan GA, Nkoy FL. The incidence of fibromyalgia and its associated comorbidities: A population-based retrospective cohort study based on International Classification of Diseases, 9th Revision codes. J Clin Rheumatol 2006, 12:124-8.
10. Goldenberg DL, Burckhardt C, Crofford L. Management of fibromyalgia syndrome. JAMA 2004, 292:2388-95.
11. Uceyler N, Hauser W, Sommer C. A systematic review on the effectiveness of treatment with antidepressants in fibromyalgia syndrome. Arthritis Rheum 2008, 59:1279-98.
12. Arnold LM, Goldenberg DL, Stanford SB. Gabapentin in the treatment of fibromyalgia: A randomized, double-blind, placebo-controlled, multicenter trial. Arthritis Rheum 2007, 56:1336-44.
13. Arnold LM, Russell IJ, Diri EW. A 14-week, randomized, double-blinded, placebo-controlled monotherapy trial of pregabalin in patients with fibromyalgia. J Pain 2008, 9:792-805.
14. Crofford LJ, Mease PJ, Simpson SL. 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.
15. Crofford LJ, Rowbotham MC, Mease PJ. Pregabalin for the treatment of fibromyalgia syndrome: Results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2005, 52:1264-73.
16. Mease PJ, Russell IJ, Arnold LM. A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. J Rheumatol 2008, 35:502-14.
17. Arnold LM, Lu Y, Crofford LJ. 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.
18. Arnold LM, Rosen A, Pritchett YL. 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.
19. Russell IJ, Mease PJ, Smith TR. 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, 136:432-44.
20. Chappell A, Bradley A, Wiltse C, D'Souza DN, Spaeth M. A six-month double-blind, placebo-controlled, randomized clinical trial of duloxetine for the treatment of fibromyalgia. Int J Gen Med 2007, 1:91-102.
21. Mease PJ, Russell IJ, Kajdasz DK. Long-term safety, tolerability, and efficacy of duloxetine in the treatment of fibromyalgia. Semin Arthritis Rheum 2009, epub ahead of print
22. Puozzo C, Panconi E, Deprez D. Pharmacology and pharmacokinetics of milnacipran. Int Clin Psychopharmacol 2002, 17:S25-35.
23. Vaishnavi SN, Nemeroff CB, Plott SJ. Milnacipran: A comparative analysis of human monoamine uptake and transporter binding affinity. Biol Psychiatry 2004, 55:320-2.
24. Dubner R, Hargreaves KM. The neurobiology of pain and its modulation. Clin J Pain 1989, 5:S1-4.
25. Millan MJ. Descending control of pain. Prog Neurobiol 2002, 66:355-474.
26. Atkinson JH, Slater MA, Capparelli EV. Efficacy of noradrenergic and serotonergic antidepressants in chronic back pain: A preliminary concentration-controlled trial. J Clin Psychopharmacol 2007, 27:135-42.
27. Atkinson JH, Slater MA, Wahlgren DR. Effects of noradrenergic and serotonergic antidepressants on chronic low back pain intensity. Pain 1999, 83:137-45.
28. Sarzi-Puttini P, Buskila D, Carrabba M, Doria A, Atzeni F. Treatment strategy in fibromyalgia syndrome: Where are we now? Semin Arthritis Rheum 2008, 37:353-65.
29. 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.
30. Gendreau RM, Thorn MD, Gendreau JF. Efficacy of milnacipran in patients with fibromyalgia. J Rheumatol 2005, 32:1975-85.
31. Mease PJ, Clauw DJ, Gendreau RM. The efficacy and safety of milnacipran for the treatment of fibromyalgia: A randomized, double-blind, placebo-controlled trial. J Rheumatol 2009, 36:398-409.
32. Sheehan DV, Lecrubier Y, Sheehan KH. The Mini-International Neuropsychiatric Interview (M.I.N.I.): The development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998, 59:22-33.
33. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use. 2006, Guidelines for Good Clinical Practice
34. Burckhardt CS, Clark SR, Bennett RM. The fibromyalgia impact questionnaire: Development and validation. J Rheumatol 1991, 18:728-33.
35. Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J. An inventory for measuring depression. Arch Gen Psychiatry 1961, 4:561-71.
36. Hays RD, Martin SA, Sesti AM, Spritzer KL. Psychometric properties of the medical outcomes study sleep measure. Sleep Med 2005, 6:41-4.
37. Hays RD, Stewart AL, Stewart AL, Ware JE. Sleep measures. Measuring Functioning and Well-Being: The Medical Outcomes Study Approach 1992, 235-59. In, eds., Durham, NC, Duke University Press
38. Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res 1995, 39:315-25.
39. Seidenberg M, Haltiner A, Taylor MA, Hermann BB, Wyler A. Development and validation of a Multiple Ability Self-Report Questionnaire. J Clin Exp Neuropsychol 1994, 16:93-104.
40. Collins SL, Moore RA, McQuay HJ. The visual analogue pain intensity scale: What is moderate pain in millimetres? Pain 1997, 72:95-7.
41. Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J 2001, 18:205-7.
42. Farrar JT, Young JP, 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.