A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder

Indiana University-Purdue University Indianapolis, Indianapolis, Indiana, United States
Pain (Impact Factor: 5.84). 12/2005; 119(1-3):5-15. DOI: 10.1016/j.pain.2005.06.031
Source: PubMed

ABSTRACT This was a 12-week, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of duloxetine, a selective serotonin and norepinephrine reuptake inhibitor, in 354 female patients with primary fibromyalgia, with or without current major depressive disorder. Patients (90% Caucasian; mean age, 49.6 years; 26% with current major depressive disorder) received duloxetine 60 mg once daily (QD) (N=118), duloxetine 60 mg twice daily (BID) (N=116), or placebo (N=120). The primary outcome was the Brief Pain Inventory average pain severity score. Response to treatment was defined as >or=30% reduction in this score. Compared with placebo, both duloxetine-treated groups improved significantly more (P<0.001) on the Brief Pain Inventory average pain severity score. A significantly higher percentage of duloxetine-treated patients had a decrease of >or=30% in this score (duloxetine 60 mg QD (55%; P<0.001); duloxetine 60 mg BID (54%; P=0.002); placebo (33%)). The treatment effect of duloxetine on pain reduction was independent of the effect on mood and the presence of major depressive disorder. Compared with patients on placebo, patients treated with duloxetine 60 mg QD or duloxetine 60 mg BID had significantly greater improvement in remaining Brief Pain Inventory pain severity and interference scores, Fibromyalgia Impact Questionnaire, Clinical Global Impression of Severity, Patient Global Impression of Improvement, and several quality-of-life measures. Both doses of duloxetine were safely administered and well tolerated. In conclusion, both duloxetine 60 mg QD and duloxetine 60 mg BID were effective and safe in the treatment of fibromyalgia in female patients with or without major depressive disorder.

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    ABSTRACT: To identify distinct groups of patients with fibromyalgia (FM) with respect to multiple outcome measures. Data from 631 duloxetine-treated women in 4 randomized, placebo-controlled trials were included in a cluster analysis based on outcomes after up to 12 weeks of treatment. Corresponding classification rules were constructed using a classification tree method. Probabilities for transitioning from baseline to Week 12 category were estimated for placebo and duloxetine patients (Ntotal = 1188) using logistic regression. Five clusters were identified, from "worst" (high pain levels and severe mental/physical impairment) to "best" (low pain levels and nearly normal mental/physical function). For patients with moderate overall severity, mental and physical symptoms were less correlated, resulting in 2 distinct clusters based on these 2 symptom domains. Three key variables with threshold values were identified for classification of patients: Brief Pain Inventory (BPI) pain interference overall scores of <3.29 and <7.14, respectively, a Fibromyalgia Impact Questionnaire (FIQ) interference with work score of <2, and an FIQ depression score of >=5. Patient characteristics and frequencies per baseline category were similar between treatments; >80% of patients were in the 3 worst categories. Duloxetine patients were significantly more likely to improve after 12 weeks than placebo patients. A sustained effect was seen with continued duloxetine treatment. FM patients are heterogeneous and can be classified into distinct subgroups by simple descriptive rules derived from only 3 variables, which may guide individual patient management. Duloxetine showed higher improvement rates than placebo and had a sustained effect beyond 12 weeks.
    BMC Musculoskeletal Disorders 12/2014; 15(1):450. DOI:10.1186/1471-2474-15-450 · 1.90 Impact Factor
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    ABSTRACT: IntroductionThis study aimed to identify subsets of patients with fibromyalgia with similar symptom profiles using the Outcome Measures in Rheumatology (OMERACT) core symptom domains.Methods Female patients with a diagnosis of fibromyalgia and now meeting fibromyalgia research survey criteria completed the Brief Pain Inventory, the 30-item Profile of Mood States, the Medical Outcomes Sleep Scale, the Multidimensional Fatigue Inventory, the Multiple Ability Self-Report Questionnaire, the Fibromyalgia Impact Questionnaire-Revised (FIQ-R), and the Short Form-36 between 1 June 2011 and 31 October 2011. Hierarchical agglomerative clustering was used to identify subgroups of patients with similar symptom profiles. To validate the results from this sample, hierarchical agglomerative clustering was repeated in an external sample of female patients with fibromyalgia with similar inclusion criteria.ResultsA total of 581 females with a mean age of 55.1 (range 20.1 to 90.2) years were included. A four-cluster solution best fit the data and each clustering variable differed significantly (P <0.0001) among the four clusters. The four clusters divided the sample into severity levels: Cluster 1 reflects the lowest average levels across all symptoms; Cluster 4 reflects the highest average levels. Clusters 2 and 3 capture moderate symptoms levels. Clusters 2 and 3 differed mainly on profiles of anxiety and depression, with Cluster 2 having lower levels of depression and anxiety than Cluster 3, despite higher levels of pain. Results of the cluster analysis of the external sample (N¿=¿478) looked very similar to those found in the original cluster analysis, except for a slight difference in sleep problems. This was despite having patients in the validation sample who were significantly younger (P¿<¿.0001) with more severe symptoms (higher FIQ-total scores (P¿=¿.0004)).Conclusions Our study incorporated core OMERACT symptom domains, which allowed for clustering based on a comprehensive symptom profile. While our exploratory cluster solution needs longitudinal study, this approach could provide rationale to support the study of individualized clinical evaluation and intervention.
    Arthritis Research & Therapy 10/2014; 16(5):463. DOI:10.1186/s13075-014-0463-7 · 4.12 Impact Factor

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