Improvement in multiple dimensions of fatigue in patients with fibromyalgia treated with duloxetine: secondary analysis of a randomized, placebo-controlled trial

被引:33
作者
Arnold, Lesley M. [2 ]
Wang, Fujun [3 ]
Ahl, Jonna [4 ]
Gaynor, Paula J. [1 ]
Wohlreich, Madelaine M. [1 ]
机构
[1] Lilly USA LLC, Clin Res, Indianapolis, IN 46285 USA
[2] Univ Cincinnati, Coll Med, Womens Hlth Res Program, Dept Psychiat & Behav Neurosci, Cincinnati, OH 45219 USA
[3] MedImmune LLC, Stat, Gaithersburg, MD 20878 USA
[4] Lilly USA LLC, Sci Commun, Indianapolis, IN 46285 USA
关键词
QUALITY-OF-LIFE; DOUBLE-BLIND; PAIN; PREVALENCE; ARTHRITIS; SYMPTOMS; VALIDITY; MFI-20; IMPACT; SLEEP;
D O I
10.1186/ar3359
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Introduction: Fatigue is one of the most disabling symptoms associated with fibromyalgia that greatly impacts quality of life. Fatigue was assessed as a secondary objective in a 2-phase, 24-week study in outpatients with American College of Rheumatology-defined fibromyalgia. Methods: Patients were randomized to duloxetine 60-120 mg/d (N = 263) or placebo (N = 267) for the 12-week acute phase. At Week 12, all placebo-treated patients were switched to double-blind treatment with duloxetine for the extension phase. Fatigue was assessed at baseline and every 4 weeks with the Multidimensional Fatigue Inventory (MFI) scales: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Activity, and Reduced Motivation. Other assessments that may be associated with fatigue included Brief Pain Inventory (BPI) average pain, numerical scales to rate anxiety, depressed mood, bothered by sleep difficulties, and musculoskeletal stiffness. Treatmentemergent fatigue-related events were also assessed. Changes from baseline to Week 12, and from Week 12 to Week 24, were analyzed by mixed-effects model repeated measures analysis. Results: At Week 12, duloxetine versus placebo significantly (all p <.05) reduced ratings on each MFI scale, BPI pain, anxiety, depressed mood, and stiffness. Improvement in ratings of being bothered by sleep difficulties was significant only at Weeks 4 and 8. At Week 24, mean changes in all measures indicated improvement was maintained for patients who received duloxetine for all 24 weeks (n = 176). Placebo-treated patients switched to duloxetine (n = 187) had significant within-group improvement in Physical Fatigue (Weeks 16, 20, and 24); General Fatigue (Weeks 20 and 24); Mental Fatigue (Week 20); and Reduced Activity (Weeks 20 and 24). These patients also experienced significant within-group improvement in BPI pain, anxiety, depressed mood, bothered by sleep difficulties, and stiffness. Overall, the most common (> 5% incidence) fatigue-related treatment-emergent adverse events were fatigue, somnolence, and insomnia. Conclusions: Treatment with duloxetine significantly improved multiple dimensions of fatigue in patients with fibromyalgia, and improvement was maintained for up to 24 weeks.
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相关论文
共 28 条
[1]   Patient perspectives on the impact of fibromyalgia [J].
Arnold, Lesley M. ;
Crofford, Leslie J. ;
Mease, Philip J. ;
Burgess, Somali Misra ;
Palmer, Susan C. ;
Abetz, Linda ;
Martin, Susan A. .
PATIENT EDUCATION AND COUNSELING, 2008, 73 (01) :114-120
[2]   Flexible Dosed Duloxetine in the Treatment of Fibromyalgia: A Randomized, Double-blind, Placebo-controlled Trial [J].
Arnold, Lesley M. ;
Clauw, Daniel ;
Wang, Fujun ;
Ahl, Jonna ;
Gaynor, Paula J. ;
Wohlreich, Madelane M. .
JOURNAL OF RHEUMATOLOGY, 2010, 37 (12) :2578-2586
[3]   Fatigue in primary Sjogren's syndrome [J].
Barendregt, PJ ;
Visser, MRM ;
Smets, EMA ;
Tulen, JHM ;
van den Meiracker, AH ;
Boomsma, F ;
Markusse, HM .
ANNALS OF THE RHEUMATIC DISEASES, 1998, 57 (05) :291-295
[4]  
Bellamy N, 2004, J RHEUMATOL, V31, P379
[5]   An internet survey of 2,596 people with fibromyalgia [J].
Bennett, Robert M. ;
Jones, Jessie ;
Turk, Dennis C. ;
Russell, I. Jon ;
Matallana, Lynne .
BMC MUSCULOSKELETAL DISORDERS, 2007, 8 (1)
[6]  
BURCKHARDT CS, 1991, J RHEUMATOL, V18, P728
[7]  
Chappell AS, 2008, INT J GEN MED, V1, P91
[8]   Content and Criterion Validity of the Preliminary Core Dataset for Clinical Trials in Fibromyalgia Syndrome [J].
Choy, Ernest H. ;
Arnold, Lesley M. ;
Clauw, Daniel J. ;
Crofford, Leslie J. ;
Glass, Jennifer M. ;
Simon, Lee S. ;
Martin, Susan A. ;
Strand, C. Vibeke ;
Williams, David A. ;
Mease, Philip J. .
JOURNAL OF RHEUMATOLOGY, 2009, 36 (10) :2330-2334
[9]  
Cleeland C. S., 1994, Annals Academy of Medicine Singapore, V23, P129
[10]   Assessment of fatigue in patients with fibromyalgia and chronic widespread pain. Reliability and validity of the Swedish version of the MFI-20 [J].
Ericsson, Anna ;
Mannerkorpi, Kaisa .
DISABILITY AND REHABILITATION, 2007, 29 (22) :1665-1670