Preliminary experience using milnacipran in patients with juvenile fibromyalgia: Lessons from a clinical trial program

Pediatric Rheumatology

Volumn 13, Issue 1, 2015, Pages

  Arnold, Lesley M ^a   Bateman, Lucinda ^b   Palmer, Robert H ^c   Lin, Yuhua ^c  

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

^b Fatigue Consultation Clinic   (United States)

^c FOREST RESEARCH INSTITUTE   (United States)

Author keywords

Juvenile fibromyalgia; Milnacipran; Pain; Quality of life

Indexed keywords

MILNACIPRAN; PLACEBO; ADRENERGIC RECEPTOR AFFECTING AGENT; CYCLOPROPANE DERIVATIVE;

ABDOMINAL PAIN; ADOLESCENT; ANXIETY ASSESSMENT; ANXIETY DISORDER; ARTICLE; CHOLECYSTITIS; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; DYSMENORRHEA; ELEVATED BLOOD PRESSURE; FATIGUE; FEMALE; FIBROMYALGIA; GASTROENTERITIS; HEADACHE; HEART PALPITATION; HEART RATE; HOT FLUSH; HUMAN; HYPERHIDROSIS; INSOMNIA; IRRITABILITY; JUVENILE FIBROMYALGIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIDIMENSIONAL ANXIETY SCALE FOR CHILDREN; MUSCULOSKELETAL DISEASE ASSESSMENT; NAUSEA; OUTCOME ASSESSMENT; PAIN SEVERITY; PATIENT GLOBAL IMPRESSION OF SEVERITY; PEDIATRIC QUALITY OF LIFE INVENTORY; PRIORITY JOURNAL; QRS INTERVAL; QUALITY OF LIFE ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; RASH; RHINOPHARYNGITIS; SIDE EFFECT; SUICIDAL IDEATION; SYSTOLIC BLOOD PRESSURE; TACHYCARDIA; TREATMENT DURATION; TREMOR; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VOMITING; WEIGHT REDUCTION; EARLY TERMINATION OF CLINICAL TRIAL; TREATMENT OUTCOME;

ADOLESCENT; ADRENERGIC UPTAKE INHIBITORS; CYCLOPROPANES; DOUBLE-BLIND METHOD; EARLY TERMINATION OF CLINICAL TRIALS; FEMALE; FIBROMYALGIA; HUMANS; MALE; TREATMENT OUTCOME;

EID: 84933048166     PISSN: None     EISSN: 15460096     Source Type: Journal    
DOI: 10.1186/s12969-015-0025-9     Document Type: Article

References (55)

1. Clark P, Burgos-Vargas R, Medina-Palma C, Lavielle P, Marina FF. Prevalence of fibromyalgia in children: a clinical study of Mexican children. J Rheumatol. 1998;25:2009-14.
2. Buskila D. Pediatric fibromyalgia. Rheum Dis Clin North Am. 2009;35:253-61.
3. Durmaz Y, Alayli G, Canbaz S, Zahiroglu Y, Bilgici A, Ilhanli I, et al. Prevalence of juvenile fibromyalgia syndrome in an urban population of Turkish adolescents: impact on depressive symptoms, quality of life and school performance. Chin Med J (Engl). 2013;126:3705-11.
4. Kashikar-Zuck S, Ting TV. Juvenile fibromyalgia: current status of research and future developments. Nat Rev Rheumatol. 2014;10:89-96.
5. Lommel K, Kapoor S, Bamford J, Melguizo MS, Martin C, Crofford L. Juvenile primary fibromyalgia syndrome in an inpatient adolescent psychiatric population. Int J Adolesc Med Health. 2009;21:571-9.
6. Yunus MB, Masi AT. Juvenile primary fibromyalgia syndrome. A clinical study of thirty-three patients and matched normal controls. Arthritis Rheum. 1985;28:138-45.
7. 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.
8. Kashikar-Zuck S, Lynch AM, Graham TB, Swain NF, Mullen SM, Noll RB. Social functioning and peer relationships of adolescents with juvenile fibromyalgia syndrome. Arthritis Rheum. 2007;57:474-80.
9. Kashikar-Zuck S, Lynch AM, Slater S, Graham TB, Swain NF, Noll RB. Family factors, emotional functioning, and functional impairment in juvenile fibromyalgia syndrome. Arthritis Rheum. 2008;59:1392-8.
10. Kashikar-Zuck S, Parkins IS, Graham TB, Lynch AM, Passo M, Johnston M, et al. Anxiety, mood, and behavioral disorders among pediatric patients with juvenile fibromyalgia syndrome. Clin J Pain. 2008;24:620-6.
11. Sil S, Kashikar-Zuck S. Understanding why cognitive-behavioral therapy is an effective treatment for adolescents with juvenile fibromyalgia. Int J Clin Rheumtol. 2013;8.
12. Kashikar-Zuck S, Swain NF, Jones BA, Graham TB. Efficacy of cognitive-behavioral intervention for juvenile primary fibromyalgia syndrome. J Rheumatol. 2005;32:1594-602.
13. Degotardi PJ, Klass ES, Rosenberg BS, Fox DG, Gallelli KA, Gottlieb BS. Development and evaluation of a cognitive-behavioral intervention for juvenile fibromyalgia. J Pediatr Psychol. 2006;31:714-23.
14. Kashikar-Zuck S, Ting TV, Arnold LM, Bean J, Powers SW, Graham TB, et al. Cognitive behavioral therapy for the treatment of juvenile fibromyalgia: a multisite, single-blind, randomized, controlled clinical trial. Arthritis Rheum. 2012;64:297-305.
15. Kashikar-Zuck S, Flowers SR, Strotman D, Sil S, Ting TV, Schikler KN. Physical activity monitoring in adolescents with juvenile fibromyalgia: findings from a clinical trial of cognitive-behavioral therapy. Arthritis Care Res (Hoboken). 2013;65:398-405.
16. Sil S, Arnold LM, Lynch-Jordan A, Ting TV, Peugh J, Cunningham N, et al. Identifying treatment responders and predictors of improvement after cognitive-behavioral therapy for juvenile fibromyalgia. Pain. 2014;155:1206-12.
17. Gualano B, Sa Pinto AL, Perondi B, Leite Prado DM, Omori C, Almeida RT, et al. Evidence for prescribing exercise as treatment in pediatric rheumatic diseases. Autoimmun Rev. 2010;9:569-73.
18. Stephens S, Feldman BM, Bradley N, Schneiderman J, Wright V, Singh-Grewal D, et al. Feasibility and effectiveness of an aerobic exercise program in children with fibromyalgia: results of a randomized controlled pilot trial. Arthritis Rheum. 2008;59:1399-406.
19. Mariutto EN, Stanford SB, Kashikar-Zuck S, Welge JA, Arnold LM. An exploratory, open trial of fluoxetine treatment of juvenile fibromyalgia. J Clin Psychopharmacol. 2012;32:293-5.
20. Mease PJ, Dundon K, Sarzi-Puttini P. Pharmacotherapy of fibromyalgia. Best Pract Res Clin Rheumatol. 2011;25:285-97.
21. 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.
22. 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.
23. Arnold LM, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Improvement in multiple dimensions of fatigue in patients with fibromyalgia treated with duloxetine: secondary analysis of a randomized, placebo-controlled trial. Arthritis Res Ther. 2011;13:R86.
24. 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.
25. 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.
26. Arnold LM, Russell IJ, Diri EW, Duan WR, Young Jr 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.
27. Mease PJ, Russell IJ, Arnold LM, Florian H, Young Jr JP, 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;35:502-14.
28. 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;55:320-2.
29. Lyrica (pregabalin). Prescribing information. New York, NY: Pfizer; 2013.
30. Cymbalta (duloxetine hydrochloride). Prescribing information. Indianapolis, IN: Eli Lilly and Company; 2014.
31. Savella (milnacipran hydrochloride). Prescribing information. New York, NY: Forest Laboratories, Inc; 2013.
32. Arnold LM, Clauw DJ, McCarberg BH, FibroCollaborative. Improving the recognition and diagnosis of fibromyalgia. Mayo Clin Proc. 2011;86:457-64.
33. Pfizer reports top-line results from a Phase 4 study evaluating Lyrica® capsules CV as a treatment for adolescents with fibromyalgia [press release]. March 12, 2015. Available from: http://www.pfizer.com/news/press-release . Accessed 1 June 2015.
34. Sheehan DV, Sheehan KH, Shytle RD, Janavs J, Bannon Y, Rogers JE, et al. Reliability and validity of the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). J Clin Psychiatry. 2010;71:313-26.
35. 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.
36. Varni JW, Burwinkle TM, Limbers CA, Szer IS. The PedsQL as a patient-reported outcome in children and adolescents with fibromyalgia: an analysis of OMERACT domains. Health Qual Life Outcomes. 2007;5:9.
37. March JS, Parker JD, Sullivan K, Stallings P, Conners CK. The Multidimensional Anxiety Scale for Children (MASC): factor structure, reliability, and validity. J Am Acad Child Adolesc Psychiatry. 1997;36:554-65.
38. Kovacs M. Children's depression inventory, 2nd edition. In: Multi-Health Systems I, editor. 1992
39. Arnold LM, Williams DA, Hudson JI, Martin SA, Clauw DJ, Crofford LJ, et al. Development of responder definitions for fibromyalgia clinical trials. Arthritis Rheum. 2012;64:885-94.
40. Crofford LJ, Mease PJ, Simpson SL, Young Jr 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;136:419-31.
41. Clauw DJ, Mease PJ, Palmer RH, Trugman JM, Wang Y. Continuing efficacy of milnacipran following long-term treatment in fibromyalgia: a randomized trial. Arthritis Res Ther. 2013;15:R88.
42. Mease PJ, Clauw DJ, Trugman JM, Palmer RH, Wang Y. Efficacy of long-term milnacipran treatment in patients meeting different thresholds of clinically relevant pain relief: subgroup analysis of a double-blind, placebo-controlled withdrawal study. J Pain Res. 2014;7:679-87.
43. 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.
44. Campos RP, Vazquez Rodriguez MI. Health-related quality of life in women with fibromyalgia: clinical and psychological factors associated. Clin Rheumatol. 2012;31:347-55.
45. Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014;311:1547-55.
46. Vincent A, Lahr BD, Wolfe F, Clauw DJ, Whipple MO, Oh TH, et al. Prevalence of fibromyalgia: a population-based study in Olmsted County, Minnesota, utilizing the Rochester Epidemiology Project. Arthritis Care Res (Hoboken). 2013;65:786-92.
47. Ivarsson T. Normative data for the Multidimensional Anxiety Scale for Children (MASC) in Swedish adolescents. Nord J Psychiatry. 2006;60:107-13.
48. Choy E, Perrot S, Leon T, Kaplan J, Petersel D, Ginovker A, et al. A patient survey of the impact of fibromyalgia and the journey to diagnosis. BMC Health Serv Res. 2010;10:102.
49. Clauw DJ. Potential mechanisms in chemical intolerance and related conditions. Ann N Y Acad Sci. 2001;933:235-53.
50. Arreola R, Becerril-Villanueva E, Cruz-Fuentes C, Velasco-Velazquez MA, Garces-Alvarez ME, Hurtado-Alvarado G, et al. Immunomodulatory effects mediated by serotonin. J Immunol Res. 2015;2015:354957.
51. Yokota S, Kikuchi M, Miyamae T. Juvenile fibromyalgia: Guidance for management. Pediatr Int. 2013;55:403-9.
52. Hilliard ME, Lawrence JM, Modi AC, Anderson A, Crume T, Dolan LM, et al. Identification of minimal clinically important difference scores of the PedsQL in children, adolescents, and young adults with type 1 and type 2 diabetes. Diabetes Care. 2013;36:1891-7.
53. Knowles RL, Day T, Wade A, Bull C, Wren C, Dezateux C, et al. Patient-reported quality of life outcomes for children with serious congenital heart defects. Arch Dis Child. 2014;99:413-9.
54. Saxe PA, Arnold LM, Palmer RH, Gendreau RM, Chen W. Short-term (2-week) effects of discontinuing milnacipran in patients with fibromyalgia. Curr Med Res Opin. 2012;28:815-21.
55. Baiardi P, Giaquinto C, Girotto S, Manfredi C, Ceci A, Excellence TNo. Innovative study design for paediatric clinical trials. Eur J Clin Pharmacol. 2011;67 Suppl 1:109-15.