Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
The Effect of Duloxetine on Cognition in Patients with Fibromyalgia.
Mease3, Philip J., Arnold4, Lesley, Wang1, Fujun, Ahl1, Jonna, Mohs1, Richard, Gaynor1, Paula, Wohlreich2, Madelaine
Eli Lilly and Company
Lilly USA, LLC
Seattle Rheumatology Associate, Seattle, WA
Women's Health Research Program, Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati, OH
Cognitive difficulties are common complaints among patients with fibromyalgia and include perceived deficits in attention, concentration and memory. Cognitive testing was conducted in a subset of patients participating in a randomized, double-blind, placebo-controlled trial of duloxetine in fibromyalgia.
At selected sites, patients eligible for the main study were asked if they would like to participate in the cognitive testing and provided separate informed consent for this testing. Patients were >=18 years of age, met ACR criteria for fibromyalgia, and >=4 score on the Brief Pain Inventory (BPI) 24-h average pain severity item. Patients who consented to cognitive testing were randomized to duloxetine (n=80) or placebo (n=76) for 24 weeks of double-blind treatment. The primary endpoint was at Week 12, after which placebo patients were switched to double-blind treatment with duloxetine. The results presented here are for the first 12 weeks. Verbal learning and memory was tested using the 15 word Verbal Learning and Recall Test (VLRT); speed of processing, visual attention and executive function were tested using the Symbol Digit Substitution Test (SDST), the Two Digit Cancellation Test (2DCT), and the Trailmaking Test (Trails A and B). Change from baseline to endpoint (last-observation-carried-forward) was analyzed by an analysis of covariance model, which included baseline, treatment, investigator and treatment-by-investigator interaction.
Most of the patients (N=156) were Caucasian (89%) women (92%), ranging in age from 21 to 88 years, 23% had comorbid major depressive disorder (MDD), and 8% had comorbid generalized anxiety disorder (GAD). Cognitive test scores at baseline were close to published scores14 for the general population indicating no impairment. Baseline-to-endpoint changes in cognitive scores did not differ significantly between treatment groups.
Impairment in cognitive function in patients with fibromyalgia was not evident on VLRT, SDST, 2DCT, or Trails A and B. Overall, treatment with duloxetine did not have a positive or negative effect on cognition when measured with these tests.
To cite this abstract, please use the following information:
Mease, Philip J., Arnold, Lesley, Wang, Fujun, Ahl, Jonna, Mohs, Richard, Gaynor, Paula, et al; The Effect of Duloxetine on Cognition in Patients with Fibromyalgia. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :113