An open-label, long-term, phase III extension trial of duloxetine in Japanese patients with fibromyalgia

Murakami, Masato; Osada, Keizo; Ichibayashi, Hisao; Mizuno, Hiromichi; Ochiai, Toshimitsu; Ishida, Mitsuhiro; Alev, Levent; Nishioka, Kusuki

doi:10.1080/14397595.2016.1245237

Cited by 11 publications

(11 citation statements)

References 19 publications

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“…Similar incidence rates and types of AEs have also been observed in long-term studies of duloxetine in other chronic pain conditions, 23 – 26 including in Japanese patients. 27 , 28 In a 52-week extension study of duloxetine 60 mg in Japanese patients with fibromyalgia, the most common AEs considered treatment-related were somnolence (22.8%), constipation (18.1%), nausea (14.8%), weight increase (9.4%), dry mouth (7.4%), and malaise (5.4%). 27 Most of these AEs occurred during the first 8 weeks of treatment.…”

Section: Discussionmentioning

confidence: 99%

“… 27 , 28 In a 52-week extension study of duloxetine 60 mg in Japanese patients with fibromyalgia, the most common AEs considered treatment-related were somnolence (22.8%), constipation (18.1%), nausea (14.8%), weight increase (9.4%), dry mouth (7.4%), and malaise (5.4%). 27 Most of these AEs occurred during the first 8 weeks of treatment. Similarly, in a 52-week extension study of duloxetine (40 mg or 60 mg) in Japanese patients with diabetic peripheral neuropathic pain (DPNP), the most common duloxetine-related AEs were somnolence (13.6%), nausea (10.5%), dizziness (7.0%), malaise (4.3%), and vomiting (7.4%).…”

Section: Discussionmentioning

confidence: 99%

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Safety and efficacy of duloxetine in Japanese patients with chronic knee pain due to osteoarthritis: an open-label, long-term, Phase III extension study

Uchio

Enomoto

Ishida

et al. 2018

JPR

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PurposeTo assess long-term safety, tolerability, and efficacy of duloxetine in Japanese patients with chronic knee pain due to osteoarthritis.MethodsIn this open-label extension study (NCT02335346), Japanese patients with knee osteoarthritis and pain (Brief Pain Inventory [BPI] – Severity average pain score ≥4 at start of randomized trial) who had previously received duloxetine 60 mg/day or placebo for 14 weeks in a double-blind randomized trial entered the extension and received duloxetine 60 mg/day for 48 weeks. The primary outcome was safety/tolerability, secondary outcomes were change in BPI-Severity (BPI-S) average pain, BPI-Interference (BPI-I), Patient Global Impression-Improvement (PGI-I), Clinical Global Impression-Improvement (CGI-I), 36-item Short-Form Health Survey (SF36), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and exploratory outcomes were knee range of motion (efficacy outcome) and Kellgren–Lawrence grade (safety outcome).ResultsOf 323 patients who completed the randomized trial, 93 (50 placebo, 43 duloxetine) entered the extension. Most patients (85, 91.4%) experienced an adverse event, most commonly constipation, nasopharyngitis, somnolence, and dry mouth (≥10% of patients). There were eight serious adverse events in seven patients and no deaths. No obvious duloxetine-related changes were observed in laboratory tests, vital signs, or electrocardiograms. The change from baseline in BPI-S average pain score was significant throughout the extension. Significant reductions in BPI-I, PGI-I, CGI-I, WOMAC, and SF36 scores were also maintained through 52 weeks. There were no substantial changes in range of motion or Kellgren–Lawrence grade.ConclusionIn Japanese patients with chronic knee pain due to osteoarthritis, long-term treatment with duloxetine was well tolerated and associated with sustained improvements in pain and health-related quality of life without radiographic deterioration.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of duloxetine in Japanese patients with chronic knee pain due to osteoarthritis: an open-label, long-term, Phase III extension study

Uchio

Enomoto

Ishida

et al. 2018

JPR

Self Cite

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“…Higher doses are associated with more adverse events (Cording 2015; Häuser 2010b). Treatment has only been continued in responders, that is to say in people who reached the predefined treatment goals with a reasonable tolerability of duloxetine or milnacipran (Petzke 2017). …”

Section: Authors' Conclusionmentioning

confidence: 99%

“…Treating fibromyalgia with drugs only, such as SNRIs alone, is discouraged since current best practices in fibromyalgia guidelines recommend using the combination of pharmacological therapy with aerobic exercise and psychological therapies (Ablin 2013; MacFarlane 2017; Petzke 2017). This is especially true for symptoms where duloxetine and milnacipran are ineffective, but other therapies are effective, for example, aerobic exercise for fatigue (Häuser 2010c), and cognitive-behavioral therapies for depression (Bernardy 2017).…”

Section: Authors' Conclusionmentioning

confidence: 99%

Serotonin and noradrenaline reuptake inhibitors (SNRIs) for fibromyalgia

Welsch

Üçeyler

Klose

et al. 2018

Cochrane Database of Systematic Reviews

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Background Fibromyalgia is a clinically defined chronic condition of unknown etiology characterized by chronic widespread pain that often co‐exists with sleep disturbances, cognitive dysfunction and fatigue. People with fibromyalgia often report high disability levels and poor quality of life. Drug therapy, for example, with serotonin and noradrenaline reuptake inhibitors (SNRIs), focuses on reducing key symptoms and improving quality of life. This review updates and extends the 2013 version of this systematic review. Objectives To assess the efficacy, tolerability and safety of serotonin and noradrenaline reuptake inhibitors (SNRIs) compared with placebo or other active drug(s) in the treatment of fibromyalgia in adults. Search methods For this update we searched CENTRAL, MEDLINE, Embase, the US National Institutes of Health and the World Health Organization (WHO) International Clinical Trials Registry Platform for published and ongoing trials and examined the reference lists of reviewed articles, to 8 August 2017. Selection criteria We selected randomized, controlled trials of any formulation of SNRIs against placebo or any other active treatment of fibromyalgia in adults. Data collection and analysis Three review authors independently extracted data, examined study quality, and assessed risk of bias. For efficacy, we calculated the number needed to treat for an additional beneficial outcome (NNTB) for pain relief of 50% or greater and of 30% or greater, patient's global impression to be much or very much improved, dropout rates due to lack of efficacy, and the standardized mean differences (SMD) for fatigue, sleep problems, health‐related quality of life, mean pain intensity, depression, anxiety, disability, sexual function, cognitive disturbances and tenderness. For tolerability we calculated number needed to treat for an additional harmful outcome (NNTH) for withdrawals due to adverse events and for nausea, insomnia and somnolence as specific adverse events. For safety we calculated NNTH for serious adverse events. We undertook meta‐analysis using a random‐effects model. We assessed the evidence using GRADE and created a 'Summary of findings' table. Main results We added eight new studies with 1979 participants for a total of 18 included studies with 7903 participants. Seven studies investigated duloxetine and nine studies investigated milnacipran against placebo. One study compared desvenlafaxine with placebo and pregabalin. One study compared duloxetine with L‐carnitine. The majority of studies were at unclear or high risk of bias in three to five domains. The quality of evidence of all comparisons of desvenlafaxine, duloxetine and milnacipran versus placebo in studies with a parallel design was low due to concerns about publication bias and indirectness, and very low for serious adverse events due to concerns about...

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“…Venlafaxine MDD, AD, syndrome of chronic pain, BDD [85,86] Desvenlafaxine MDD in adult patients [89] Duloxetine MDD, DPNP, fibromyalgia [96,104,107] Atomoxetine ADHD in adults and pediatric patients under 6 years old [103,108] Sibutramine Treatment of obesity [106] Milnacipran MDD, fibromyalgia [85,105] Levomilnacipran MDD, AD in adult patients [90] Abbreviations: MDD, major depression disorder; BDD, bipolar depression disorder; AD, anxiety disorder; DPNP, diabetic peripheral neuropathy pain; ADHD, attention deficit hyperactivity disorder. Indeed, in some cases they work better than classic antidepressant drugs (e.g., SSRIs and tricyclic drugs) in certain groups of patients.…”

Section: Active Compound Therapeutic Use Referencementioning

confidence: 99%

Association of 5-HT1A Receptors with Affective Disorders

Soria-Fregozo¹,

Vega²,

FranciscoRodríguez-Landa³

et al. 2017

Serotonin - A Chemical Messenger Between All Types of Living Cells

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Serotonin or 5-hydroxytryptamine (5-HT) is synthesized in both the brain and peripheral system, which exert their actions at a wide family of receptors classified as 5-HT 1 to 5-HT 7 . Pharmacological, behavioral, and clinical studies involve particularly to the 5-HT 1A receptors (5-HT 1A -R) -auto-receptors (presynaptic) and heteroreceptors (postsynaptic) -in the control of motivated behavior, and consequently in the physiopathology of affective disorders and in the action mechanism of antidepressant drugs. In this way, some research support that 5-HT 1A -R participates in the delayed effect of different types of antidepressants, including selective serotonin reuptake inhibitors (SSRIs), and tricyclic drugs, principally. The therapeutic effect of serotonergic drugs as the SSRIs, starting with the binding to auto-receptors, which produces increases of 5-HT in the synaptic cleft as consequence of blockade of serotonin reuptake. While these molecular events occur initially, in the long-term are produced plastic changes at neuronal level, as well as down-regulation of the 5-HT 1A -R, which is associated with the therapeutic effects of antidepressant drugs. The purpose of this chapter is to analyze and discuss the current information about of 5-HT 1A -R-mediated signaling cascades, the intracellular signaling of 5-HT 1A -R, in addition to their expression and pharmacology that are important to treatment of affective disorders symptoms.

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An open-label, long-term, phase III extension trial of duloxetine in Japanese patients with fibromyalgia

Abstract: Duloxetine was safe and effective in the long-term treatment of Japanese patients with fibromyalgia.

Cited by 11 publications

References 19 publications

Safety and efficacy of duloxetine in Japanese patients with chronic knee pain due to osteoarthritis: an open-label, long-term, Phase III extension study

Safety and efficacy of duloxetine in Japanese patients with chronic knee pain due to osteoarthritis: an open-label, long-term, Phase III extension study

Serotonin and noradrenaline reuptake inhibitors (SNRIs) for fibromyalgia

Association of 5-HT1A Receptors with Affective Disorders

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