A randomized, double-blind, placebo-controlled phase III trial of duloxetine in Japanese fibromyalgia patients
Open accessAbstract
INTRODUCTION: Fibromyalgia is characterized by widespread pain and is often accompanied by accessory symptoms. There are limited treatment options for this condition in Japan. Therefore, we conducted a phase III study to assess the efficacy and safety of duloxetine in Japanese patients with fibromyalgia. METHODS: This randomized, double-blind, placebo-controlled, parallel-group trial was conducted in Japan. Outpatients who met the American College of Rheumatology 1990 criteria for fibromyalgia and whose Brief Pain Inventory (BPI) average pain score was ≥4 were randomized to duloxetine 60 mg or placebo once daily for 14 weeks. The primary efficacy measure was the change in the BPI average pain score from baseline. Secondary efficacy, quality of life (QoL), and safety outcomes were also evaluated. Mixed-effects model repeated-measures (MMRM) analysis and last observation carried forward (LOCF) analysis of covariance were used to evaluate the primary efficacy measure. RESULTS: Overall, 393 patients were randomized to receive either duloxetine (n = 196) or placebo (n = 197). The MMRM analysis revealed no significant difference between duloxetine and placebo regarding the change in BPI average pain scores at week 14. Based on LOCF analysis, a statistically significant improvement in the change in BPI average pain scores at week 14 was observed for patients treated with duloxetine compared with placebo. Duloxetine treatment was associated with improved outcomes in nearly all secondary and post hoc analyses. The treatment was generally well tolerated. Somnolence, nausea, and constipation were the most common treatment-emergent adverse events in the duloxetine group. The discontinuation rates due to treatment-emergent adverse events were similar in both groups. CONCLUSIONS: Although the MMRM analysis did not demonstrate superiority of duloxetine over placebo, duloxetine treatment was associated with improved outcomes in secondary and post hoc analyses of the mean change in the BPI average pain score and most of the secondary outcomes, including analgesia and QoL. Duloxetine treatment was safe and well tolerated. These results suggest that duloxetine treatment could be associated with improvements in pain relief and QoL in Japanese patients with fibromyalgia. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01552057 . Registered 9 March 2012.
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Which dose of duloxetine is optimal for fibromyalgia remains controversial.
“however, which dose is optimal for fibromyalgia remains controversial.”
From Duloxetine for fibromyalgia syndrome: a systematic review and meta-analysis (2023) · cites this paper as [24]
The Methods (Study design; page unavailable) describe titration to 60 mg, and the Discussion (Analgesic effect of duloxetine on fibromyalgia; page unavailable) notes that once-daily 60 mg was approved in other countries. Neither passage addresses whether the optimal dose is controversial; searches for optimal dosage and comparisons among doses found no such statement in our copy. (LLM, conf=0.72)
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- Authors
- Murakami, M., Osada, K., Mizuno, H., Ochiai, T., Alev, L., & Nishioka, K.
- Affiliations
- Nihon University (JP)
- St. Marianna University School of Medicine (JP)
- Shionogi (Japan) (JP)
- Eli Lilly (Japan) (JP)
- Tokyo Medical University (JP)
- Corresponding author
- Nishioka, Kusuki
- Venue
- Arthritis Research & Therapy
- Published
- 2015-08-22
- Volume
- 17
- Issue
- 1
- Pages
- 224-224
- ISSN
- 1478-6354 (ISSN-L)
- PMC
- PMC4546310
- OpenAlex
- W1883416684
- Cited by
- 46
- References
- 39
- Citations by year
- 2026: 2 · 2025: 1 · 2024: 6 · 2023: 5 · 2022: 7 · 2021: 5 · 2020: 3 · 2019: 4 · 2018: 2 · 2017: 7 · 2016: 4
- FWCI
- 3.52
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Arthritis Research & Therapy (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- Eli Lilly and Company
- Shionogi
- Eli Lilly Japan
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
- Health Sciences › Medicine › Physiology › Pain Mechanisms and Treatments
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Keywords
- duloxetine, fibromyalgia, Japanese patients, Brief Pain Inventory, quality of life, analgesia, treatment-emergent adverse events, sleepiness, drug safety, antidepressant efficacy
- MeSH terms
- Duloxetine Hydrochloride, Adult, Analgesics, Constipation, Double-Blind Method, Female, Fibromyalgia, Humans, Disorders of Excessive Somnolence, Japan, Male, Middle Aged, Nasopharyngitis, Nausea, Outpatients, Pain Measurement, Quality of Life, Treatment Outcome, Asian People
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