Oral dexamethasone pulse therapy versus daily prednisolone in sub-acute onset myositis, a randomised clinical trial

Neuromuscular Disorders

Volumn 20, Issue 6, 2010, Pages 382-389

  van de Vlekkert, J ^a   Hoogendijk, J ^b   de Haan, R J ^a   Algra, A ^b,c   van der Tweel, I ^d   van der Pol, W L ^b   Uijtendaal, E V ^c   de Visser, M ^a  

^a UNIVERSITY OF AMSTERDAM   (Netherlands)

^b UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^c UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^d UTRECHT UNIVERSITY   (Netherlands)

Author keywords

Dermatomyositis; Idiopathic inflammatory myopathies; Neuromuscular disease; Non specific myositis; Polymyositis; Randomised controlled trials

Indexed keywords

ALENDRONIC ACID; ALPHA TOCOPHEROL; CALCIUM; DEXAMETHASONE; PLACEBO; PREDNISOLONE; ANTIINFLAMMATORY AGENT;

ACNE; ADRENAL INSUFFICIENCY; ADULT; ARTICLE; CATARACT; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CUSHINGOID SYNDROME; DIABETES MELLITUS; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG MEGADOSE; DRUG PULSE THERAPY; DRUG SAFETY; DRUG WITHDRAWAL; ECCHYMOSIS; FEMALE; FOLLOW UP; HAIR LOSS; HIRSUTISM; HUMAN; HYPERTENSION; INFECTION; INTESTINE PERFORATION; MAJOR CLINICAL STUDY; MALE; MOOD CHANGE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYOSITIS; OSTEOPOROSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RELAPSE; REMISSION; SCORING SYSTEM; SIDE EFFECT; STOMACH DISEASE; STRIA; WEIGHT GAIN; WOUND HEALING IMPAIRMENT; COMPARATIVE STUDY; MIDDLE AGED; MYOSITIS, INCLUSION BODY; RISK ASSESSMENT; SAMPLE SIZE; TREATMENT OUTCOME;

ADULT; ANTI-INFLAMMATORY AGENTS; DEXAMETHASONE; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; MYOSITIS; MYOSITIS, INCLUSION BODY; PREDNISOLONE; RISK ASSESSMENT; SAMPLE SIZE; TREATMENT OUTCOME;

EID: 77953120514     PISSN: 09608966     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.nmd.2010.03.011     Document Type: Article

References (36)

1. Bronner I.M., van der Meulen M.F., de Visser M., et al. Long-term outcome in polymyositis and dermatomyositis. Ann Rheum Dis 2006, 65(11):1456-1461.
2. Dalakas M.C. Therapeutic targets in patients with inflammatory myopathies: present approaches and a look to the future. Neuromuscul Disord 2006, 16(4):223-236.
3. Choy E.H., Hoogendijk J.E., Lecky B., Winer J.B. Immunosuppressant and immunomodulatory treatment for dermatomyositis and polymyositis. Cochrane Database Syst Rev 2005, (3). CD003643.
4. Andersen J.C. Response of resistant idiopathic thrombocytopenic purpura to pulsed high-dose dexamethasone therapy. N Engl J Med 1994, 330(22):1560-1564.
5. Bromberg M.B., Carter O. Corticosteroid use in the treatment of neuromuscular disorders: empirical and evidence-based data. Muscle Nerve 2004, 30(1):20-37.
6. Cheng Y., Wong R.S., Soo Y.O., et al. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. N Engl J Med 2003, 349(9):831-836.
7. Molenaar D.S., van Doorn P.A., Vermeulen M. Pulsed high dose dexamethasone treatment in chronic inflammatory demyelinating polyneuropathy: a pilot study. J Neurol Neurosurg Psychiatry 1997, 62(4):388-390.
8. Sood A., Midha V., Sood N., Awasthi G. A prospective, open-label trial assessing dexamethasone pulse therapy in moderate to severe ulcerative colitis. J Clin Gastroenterol 2002, 35(4):328-331.
9. Toth G.G., van de Meer J.B., Jonkman M.F. Dexamethasone pulse therapy in pemphigus. J Eur Acad Dermatol Venereol 2002, 16(6):607-611.
10. Toth G.G., Westerlaken B.O., Eilders M., Laseur M., Jonkman M.F., Uges D.R. Dexamethasone pharmacokinetics after high-dose oral therapy for pemphigus. Ann Pharmacother 2002, 36(6):1108-1109.
11. Westerlaken B.O., de Kleine E., van der Laan B., Albers F. The treatment of idiopathic sudden sensorineural hearing loss using pulse therapy: a prospective, randomized, double-blind clinical trial. Laryngoscope 2007, 117(4):684-690.
12. van der Meulen M.F., Hoogendijk J.E., Wokke J.H., de Visser M. Oral pulsed high-dose dexamethasone for myositis. J Neurol 2000, 247(2):102-105.
13. Dalakas M.C., Hohlfeld R. Polymyositis and dermatomyositis. Lancet 2003, 362(9388):971-982.
14. Tanimoto K., Nakano K., Kano S., et al. Classification criteria for polymyositis and dermatomyositis. J Rheumatol 1995, 22(4):668-674.
15. Hoogendijk J.E., Amato A.A., Lecky B.R. Et al. 119th ENMC international workshop: trial design in adult idiopathic inflammatory myopathies, with the exception of inclusion body myositis. 10-12 October 2003, Naarden, The Netherlands. Neuromuscul Disord 2004, 14:337-345.
16. van Swieten J.C., Koudstaal P.J., Visser M.C., Schouten H.J., van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke 1988, 19(5):604-607.
17. Dalakas M.C., Illa I., Dambrosia J.M., et al. A controlled trial of high-dose intravenous immune globulin infusions as treatment for dermatomyositis. N Engl J Med 1993, 329(27):1993-2000.
18. Sultan S.M., Ioannou Y., Moss K., Isenberg D.A. Outcome in patients with idiopathic inflammatory myositis: morbidity and mortality. Rheumatology (Oxford) 2002, 41(1):22-26.
19. PEST 4. Operating manual. MPS Research Unit. Reading: The University of Readin. MPS Research United. The University of Reading (UK);2000.
20. Whitehead J. The design and analysis of sequential clinical trials 1997, Wiley, Chichester. Revised 2nd ed.
21. Arahata K., Engel A.G. Monoclonal antibody analysis of mononuclear cells in myopathies. I: quantitation of subsets according to diagnosis and sites of accumulation and demonstration and counts of muscle fibers invaded by T cells. Ann Neurol 1984, 16(2):193-208.
22. Van M.F.G., der Meulen I.M., Bronner J.E., Hoogendijk H., Burger W.J., Van Venrooij A.E., et al. Polymyositis. An overdiagnosed entity. Neurology 2003, 61:316-321.
23. Ferreira-Gonzalez I., Brusse J.W., Heels-Ansdell D., et al. Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials. BMJ 2007, 334:786-792.
24. Kleyweg R.P., van der Meché F.G., Schmitz P.I. Interobserver agreement in the assessment of muscle strength and functional abilities in Guillain-Barré syndrome. Muscle Nerve 1991, 14:1103-1109.
25. Merkies I.S., Schmitz P.I., Van der Meché F.G., et al. Inflammatory neuropathy cause and treatment (INCAT) group. Connecting impairment, disability, and handicap in immune mediated polyneuropathies. J Neurol Neurosurg Psychiatry 2003, 74:99-104.
26. Isenberg D.A., Allen E., Farewell V. International consensus outcome measures for patients with idiopathic inflammatory myopathies. Development and initial validation of myositis activity and damage indices in patients with adult onset disease. Rheumatology (Oxford) 2004, 43(1):49-54.
27. Lachenbruch P.A., Miller F.W., Rider L.G. Developing international consensus on measures of improvement for patients with myositis. Stat Methods Med Res 2007, 16(1):51-64.
28. Streiner D.L., Norman G.R. Heath measurement scales; a practical guide to their development and use 2008, Oxford University Press, p. 53.
29. Nunally J.C. Psychometric Theory 1978, McGraw-Hill, New York, pp. 12-33.
30. Behera M., Kumar A., Soares H.P., Sokol L., Djulbegovic B. Evidence-based medicine for rare diseases: implications for data interpretation and clinical trial design. Cancer Control 2007, 14(2):160-166.
31. Miller F.W., Leitman S.F., Cronin M.E., et al. Controlled trial of plasma exchange and leukapheresis in polymyositis and dermatomyositis. N Engl J Med 1992, 326(21):1380-1384.
32. Vencovsky J., Jarosova K., Machacek S., et al. Cyclosporine A versus methotrexate in the treatment of polymyositis and dermatomyositis. Scand J Rheumatol 2000, 29(2):95-102.
33. Villalba L., Hicks J.E., Adams E.M., et al. Treatment of refractory myositis: a randomized crossover study of two new cytotoxic regimens. Arthritis Rheum 1998, 41(3):392-399.
34. Chung Y.L., Alexanderson H., Pipitone N., et al. Creatine supplements in patients with idiopathic inflammatory myopathies who are clinically weak after conventional pharmacologic treatment: six-month, double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2007, 57(4):694-702.
35. Bunch T.W., Worthington J.W., Combs J.J., Ilstrup D.M., Engel A.G. Azathioprine with prednisone for polymyositis. A controlled, clinical trial. Ann Intern Med 1980, 92(3):365-369.
36. Miller J, Walsh Y, Saminaden S, Lecky BRF, Winer JB. Randomised double blind controlled trial of methotrexate and steroids compared with azathioprine and steroids in the treatment of idiopathic inflammatory myopathy. J Neurol Sci 2002. [Ref Type: Abstract].