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Efficacy and safety of duloxetine 30 mg/d in patients with fibromyalgia: a randomized, double-blind, placebo-controlled study.
Clin J Pain. 2012 Nov-Dec; 28(9):775-81.CJ

Abstract

OBJECTIVES

To evaluate the efficacy and safety of duloxetine 30 mg/d in adults with fibromyalgia.

METHODS

This 12-week, randomized, double-blind, placebo-controlled study was conducted in the United States, Mexico, Argentina, and Israel and enrolled patients meeting the criteria for primary fibromyalgia as defined by the American College of Rheumatology. The primary endpoint was the average pain severity item from the Brief Pain Inventory (BPI)-Modified Short Form, assessed by an analysis of covariance model using change from baseline to the modified baseline-observation-carried-forward endpoint. Secondary endpoints included the Patient Global Impression of Improvement (PGI-I) score and the Fibromyalgia Impact Questionnaire (FIQ) total score and those measuring pain, depression, anxiety, health outcomes, and safety.

RESULTS

Patients (mean age, 51 y; 95% female; 87% White; 22% with major depressive disorder) received duloxetine 30 mg/d (N=155) or placebo (N=153). Duloxetine-treated patients did not have a statistically significant BPI-Modified Short Form average pain severity reduction versus placebo-treated patients (-2.04 vs. -1.70; P=0.202). There was a significant difference between duloxetine-treated and placebo-treated patients (P<0.05) for the PGI-I endpoint score (2.97 vs. 3.35) and the changes in FIQ total score (-14.62 vs. -9.75) and the Short-Form Health Survey (SF)-36 mental component score. Discontinuations due to adverse events did not differ significantly between treatment groups; nausea and dry mouth were the only adverse events with a significantly higher incidence with duloxetine versus placebo.

DISCUSSION

Duloxetine 30 mg/d did not significantly reduce pain severity in patients with fibromyalgia. However, duloxetine-treated patients reported global improvement in symptoms and function. Safety findings were consistent with the known duloxetine safety profile.

Authors+Show Affiliations

Department of Psychiatry and Behavioral Neuroscience, Women's Health Research Program, University of Cincinnati College of Medicine, Cincinnati, OH, USA.No affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase IV
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

22971669

Citation

Arnold, Lesley M., et al. "Efficacy and Safety of Duloxetine 30 Mg/d in Patients With Fibromyalgia: a Randomized, Double-blind, Placebo-controlled Study." The Clinical Journal of Pain, vol. 28, no. 9, 2012, pp. 775-81.
Arnold LM, Zhang S, Pangallo BA. Efficacy and safety of duloxetine 30 mg/d in patients with fibromyalgia: a randomized, double-blind, placebo-controlled study. Clin J Pain. 2012;28(9):775-81.
Arnold, L. M., Zhang, S., & Pangallo, B. A. (2012). Efficacy and safety of duloxetine 30 mg/d in patients with fibromyalgia: a randomized, double-blind, placebo-controlled study. The Clinical Journal of Pain, 28(9), 775-81. https://doi.org/10.1097/AJP.0b013e3182510295
Arnold LM, Zhang S, Pangallo BA. Efficacy and Safety of Duloxetine 30 Mg/d in Patients With Fibromyalgia: a Randomized, Double-blind, Placebo-controlled Study. Clin J Pain. 2012 Nov-Dec;28(9):775-81. PubMed PMID: 22971669.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of duloxetine 30 mg/d in patients with fibromyalgia: a randomized, double-blind, placebo-controlled study. AU - Arnold,Lesley M, AU - Zhang,Shuyu, AU - Pangallo,Beth A, PY - 2012/9/14/entrez PY - 2012/9/14/pubmed PY - 2013/3/13/medline SP - 775 EP - 81 JF - The Clinical journal of pain JO - Clin J Pain VL - 28 IS - 9 N2 - OBJECTIVES: To evaluate the efficacy and safety of duloxetine 30 mg/d in adults with fibromyalgia. METHODS: This 12-week, randomized, double-blind, placebo-controlled study was conducted in the United States, Mexico, Argentina, and Israel and enrolled patients meeting the criteria for primary fibromyalgia as defined by the American College of Rheumatology. The primary endpoint was the average pain severity item from the Brief Pain Inventory (BPI)-Modified Short Form, assessed by an analysis of covariance model using change from baseline to the modified baseline-observation-carried-forward endpoint. Secondary endpoints included the Patient Global Impression of Improvement (PGI-I) score and the Fibromyalgia Impact Questionnaire (FIQ) total score and those measuring pain, depression, anxiety, health outcomes, and safety. RESULTS: Patients (mean age, 51 y; 95% female; 87% White; 22% with major depressive disorder) received duloxetine 30 mg/d (N=155) or placebo (N=153). Duloxetine-treated patients did not have a statistically significant BPI-Modified Short Form average pain severity reduction versus placebo-treated patients (-2.04 vs. -1.70; P=0.202). There was a significant difference between duloxetine-treated and placebo-treated patients (P<0.05) for the PGI-I endpoint score (2.97 vs. 3.35) and the changes in FIQ total score (-14.62 vs. -9.75) and the Short-Form Health Survey (SF)-36 mental component score. Discontinuations due to adverse events did not differ significantly between treatment groups; nausea and dry mouth were the only adverse events with a significantly higher incidence with duloxetine versus placebo. DISCUSSION: Duloxetine 30 mg/d did not significantly reduce pain severity in patients with fibromyalgia. However, duloxetine-treated patients reported global improvement in symptoms and function. Safety findings were consistent with the known duloxetine safety profile. SN - 1536-5409 UR - https://www.unboundmedicine.com/medline/citation/22971669/Efficacy_and_safety_of_duloxetine_30_mg/d_in_patients_with_fibromyalgia:_a_randomized_double_blind_placebo_controlled_study_ DB - PRIME DP - Unbound Medicine ER -