A six-month double-blind, placebo-controlled, randomized clinical trial of duloxetine for the treatment of fibromyalgia

Chappell, Amy S.; Bradley, Laurence A.; Wiltse, Curtis G.; Detke, Michael J.; D’Souza, Deborah N.; Spaeth, M. J. Drake

doi:10.2147/ijgm.s3979

Cited by 84 publications

(124 citation statements)

References 34 publications

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“…[18][19][20][21] The studies differed with respect to dosage and administration, duration of treatment, and primary outcomes ( Table 1). The study investigators included clinicians with specialties in rheumatology, primary care, chronic pain, and psychiatry.…”

Section: Methodsmentioning

confidence: 99%

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Efficacy of Duloxetine in Patients With Fibromyalgia

Arnold¹,

Clauw²,

Wohlreich³

et al. 2009

Prim. Care Companion J. Clin. Psychiatry

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Objective: To investigate the efficacy of duloxetine in the treatment of pain and improvement in functional impairment and quality of life in patients with fibromyalgia from a pooled analysis of 4 placebo-controlled, double-blind, randomized trials.Method: Patients were eligible for inclusion in the studies if they were at least 18 years of age, met criteria for fibromyalgia as defined by the American College of Rheumatology, and had specified minimum pain severity scores. Across all studies, 797 patients received duloxetine 60-120 mg/d and 535 patients received placebo. Pain was assessed by the Brief Pain Inventory (BPI) 24-hour average pain severity score; other efficacy measures included the Clinical Global Impressions-Severity of Illness scale (CGI-S), Patient Global Impressions-Improvement scale (PGI-I), 17-item Hamilton Depression Rating Scale (HDRS-17), Fibromyalgia Impact Questionnaire (FIQ) total score, BPI pain interference items, Sheehan Disability Scale (SDS), and Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) mental and physical components. Changes from baseline to endpoint (last observation carried forward) for most of the above efficacy measures were analyzed using an analysis-of-covariance model.Results: After 12 weeks of treatment, pain was significantly reduced in patients treated with duloxetine (P < .001) compared with placebo. In addition, duloxetine was superior to placebo in improving CGI-S (P < .001); PGI-I (P < .001); FIQ total (P < .001); HDRS-17 total (P = .003); SDS global functioning (P < .001), work/school (P = .018), and family life (P < .001); SF-36 mental (P < .001) and physical (P = .026) component; and BPI pain interference (P < .001) scores. Treatment-by-subgroup interactions were not significant for sex (P = .320), age (P = .362), or race (P = .180).Conclusions: This pooled analysis provides evidence that 12 weeks of treatment with duloxetine 60-120 mg/d effectively improves fibromyalgia symptoms and may offer benefits beyond pain relief.

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Section: Methodsmentioning

confidence: 99%

“…[18][19][20][21] These trials differed with respect to dosing regimens, primary measures of pain, and treatment duration, and there were inconsistent results for pain efficacy and functional outcomes. In addition, most of the fibromyalgia patients enrolled in these trials were middle-aged white women.…”

mentioning

confidence: 99%

Efficacy of Duloxetine in Patients With Fibromyalgia

Arnold¹,

Clauw²,

Wohlreich³

et al. 2009

Prim. Care Companion J. Clin. Psychiatry

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“…31,32 In the Russel's study, 520 patients meeting the ACR criteria of fibromyalgia were treated during 6 months and received different daily doses of duloxetine of 20 mg increased to 60 mg after 3 months, 60 mg, 120 mg, or a placebo. The primary outcome measures were BPI and Patient Global Impression of Improvement (PGI-I) scores.…”

Section: Clinical Studiesmentioning

confidence: 99%

“…45 It is to be noted that Russell and Chappell's studies were published in 2008 and Arnold's studies pooled in 2007. [30][31][32] A systematic review of randomized trials was undertaken in 2008. 46 Three trials concerning Duloxetine in FMS were involved.…”

Section: Efficacymentioning

confidence: 99%

“…31,32 In patients with painful diabetic neuropathy, duloxetine with a dose of 120 mg/day could be appropriate for these patients who require additional pain relief. 48 These doses may be useful in depression or anxiety, for example with 18.28% patients taking 120 mg/day in a general anxiety disorder study with flexible dosing.…”

Section: Patient Preference and Recommended Management Of Duloxetine:mentioning

confidence: 99%

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Pharmacotherapy of Fibromyalgia: Focus on Duloxetine

Serra

Andréjak

2009

Clinical Medicine. Therapeutics

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Context: Fibromyalgia syndrome (FMS) is a frequent medical condition characterized by chronic widespread pain and reduced pain threshold. Associated symptoms include fatigue, non restorative sleep, and psychological distress. As usual in medicine, even if the pathogenesis is unclear, some treatments are useful to help patients. Objectives: Tricyclic antidepressants were the first drugs used to treat FMS. More recently, among serotonin-norepinephrine reuptake inhibitors, duloxetine was approved by US Food and Drug Administration to treat FMS. Duloxetine is used for the management of major depressive disorder, neuropathic pain, generalized anxiety disorder, and stress incontinence. In the pharmacotherapy of fibromyalgia, a focus is presented on the drug duloxetine. Results: Mechanism of action, metabolism and pharmacokinetic profile are presented. Clinical studies of Duloxetine showed an acceptable efficacy for this chronic condition: Number Need to Treat (NTT) of 4.7 to 9.9, through two 3-month placebo-controlled trials and two 6-month trials. Evaluation criteria are discussed. Safety of this medication has been found to be satisfactory, with nausea as the most common adverse event, in almost 20% of cases. Conclusion: Treatment algorithm for duloxetine is presented inside FMS treatment strategy. With duloxetine, it is important to start low and increase slowly to prevent or minimize adverse events: 30 mg/day up to 60 mg/day in the second week and if necessary up to 90-120 mg/day. It is possible to treat for 3 to 6 months, possibly up to 12 months. The drug could be decreased 2 to 4 weeks before stopping, with regular assessments during this time. International recommendations insist on multimodal treatments: drug and non drug. Also effective for anxiety and depression, duloxetine ranks among the first place drugs for FMS.

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Comparison of Amitriptyline and US Food and Drug Administration–Approved Treatments for Fibromyalgia

et al. 2022

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IMPORTANCE Amitriptyline is an established medication used off-label for the treatment of fibromyalgia, but pregabalin, duloxetine, and milnacipran are the only pharmacological agents approved by the US Food and Drug Administration (FDA) to treat fibromyalgia. OBJECTIVE To investigate the comparative effectiveness and acceptability associated with pharmacological treatment options for fibromyalgia.

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A six-month double-blind, placebo-controlled, randomized clinical trial of duloxetine for the treatment of fibromyalgia

Cited by 84 publications

References 34 publications

Efficacy of Duloxetine in Patients With Fibromyalgia

Efficacy of Duloxetine in Patients With Fibromyalgia

Pharmacotherapy of Fibromyalgia: Focus on Duloxetine

Comparison of Amitriptyline and US Food and Drug Administration–Approved Treatments for Fibromyalgia

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