Author: Lesley ArnoldFujun WangJonna AhlPaula GaynorMadelaine Wohlreich
Credits/Source: Arthritis Research &Therapy 2011, 13:R86
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. Treatment-emergent 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.Trial Registration: Clinical Trial Registry NCT00673452.
http://7thspace.com/headlines/385919/improvement_in_multiple_dimensions_of_fatigue_in_patients_with_fibromyalgia_treated_with_duloxetine__secondary_analysis_of_a_randomized_placebo_controlled_trial.html
Credits/Source: Arthritis Research &Therapy 2011, 13:R86
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. Treatment-emergent 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.Trial Registration: Clinical Trial Registry NCT00673452.
http://7thspace.com/headlines/385919/improvement_in_multiple_dimensions_of_fatigue_in_patients_with_fibromyalgia_treated_with_duloxetine__secondary_analysis_of_a_randomized_placebo_controlled_trial.html
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