TY - JOUR
T1 - Effect of duloxetine in patients with fibromyalgia
T2 - Tiredness subgroups
AU - Bradley, Laurence A.
AU - Bennett, Robert
AU - Russell, Irwin J.
AU - Wohlreich, Madelaine M.
AU - Chappell, Amy S.
AU - Wang, Fujun
AU - D'Souza, Deborah N.
AU - Moldofsky, Harvey
N1 - Funding Information:
Dr Bradley is a consultant for Eli Lilly, Pfizer, and Forest; has received grant/ research support from the National Institutes of Health, the Agency for Healthcare Research and Quality, Eli Lilly, Pfizer, and the American Fibromyalgia Syndrome Association; has received honoraria from Eli Lilly, Pfizer, Forest, and the Society for Women’s Health Research; is a member of the speakers/advisory board for Eli Lilly and Company; and has received royalties from UpToDate Rheumatology. Dr Bennett is on advisory boards for Eli Lilly and Company, Schwarz, Jazz and Pfizer. Dr. Russell has received honorarium as a consultant and speaker for Pfizer, Eli Lilly and Company, Jazz, Forest Laboratories, and Grunenthal, and as a consultant for Allergan. He has received honorarium for being a speaker on the medical advisory board for Pfizer, Eli Lilly and Company, Jazz, Pierre Fabre, Nicox, Daiichii Sankyo, and Ortho McNeil Jannssen. He has received funding as a principal investigator for Pfizer, as a local principal local investigator for Eli Lilly and Company, Allergan, and Schwarz/UCB, and as a lead investigator for Jazz, Grunenthal, and Autoimmune Technologies. Dr. Russell is the editor of the Journal of Musculoskeletal Pain and receives from the publisher a royalty for his work in that capacity. He is a member of the International MYOPAIN Society Board (non-remunerative position). Dr. Russell has never owned a pharmaceutical company, or owned stock in a pharmaceutical company that he is aware of, or worked as an employee for a pharmaceutical company. Dr Moldofsky is the principal investigator at a research site, the Toronto Psychiatric Research Foundation, a not for profit corporation that has received funds for participating in a research study, which is sponsored by Eli Lilly and Company. Dr. Moldofsky has received research support from Eli Lilly, Krele, Pfizer, Pierre Fabre, Sanofi Aventis, and Schering Plough; has acted as a consultant for Boehringer Ingleheim, Eli Lilly, Jazz Pharmaceuticals, Krele, Lundbeck, Merck, Paladin Labs, Pfizer, Pierre Fabre, Sanofi Aventis, Schering Plough, and Valeant; and was on the speaker’s bureau for Pfizer. Drs Wohlreich, Chappell, Wang, and D’Souza are employees and stockholders of Eli Lilly and Company.
Funding Information:
This work was sponsored by Eli Lilly and Company and Boehringer Ingelheim GmbH.
PY - 2010/7/14
Y1 - 2010/7/14
N2 - Introduction: This study tested the hypothesis that baseline ratings of fatigue/tiredness would be negatively associated with the efficacy of duloxetine on measures of pain and functional ability in patients with fibromyalgia.Methods: A post hoc analysis of pooled data from 4 double-blind, placebo-controlled studies of duloxetine in fibromyalgia was performed. The fibromyalgia impact questionnaire (FIQ) tiredness item score (0 to 10 scale) was used to define tiredness subgroups. Patients were stratified into 3 subgroups: mild (0 to 3), moderate (4 to 6), and severe (7 to 10) tiredness. Analysis of covariance models and logistic regressions were used to test treatment-by-tiredness subgroup interactions.Results: Data from the first 3 months are included in this post hoc analysis (duloxetine N = 797, placebo N = 535). At baseline, the distribution of tiredness severity in the duloxetine and placebo groups respectively was 3.64% and 3.75% mild, 16.71% and 15.57% moderate, and 79.65% and 80.68% severe. Rates of clinically significant (≥30% and ≥50%) improvement in brief pain inventory (BPI) average pain were similar across the tiredness subgroups. Tiredness severity at baseline was not negatively associated with the effects of duloxetine on patients' reports of functional ability using the FIQ total score, FIQ measures of physical impairment, interference with work, pain, stiffness, and depression and the medical outcomes study short form-36 (SF-36).Conclusions: Studies of duloxetine in fibromyalgia have demonstrated clinically significant improvements in pain and functional ability (FIQ, SF-36). This post hoc analysis of data shows that the efficacy of duloxetine among patients with fibromyalgia does not vary as a function of baseline ratings of fatigue/tiredness.
AB - Introduction: This study tested the hypothesis that baseline ratings of fatigue/tiredness would be negatively associated with the efficacy of duloxetine on measures of pain and functional ability in patients with fibromyalgia.Methods: A post hoc analysis of pooled data from 4 double-blind, placebo-controlled studies of duloxetine in fibromyalgia was performed. The fibromyalgia impact questionnaire (FIQ) tiredness item score (0 to 10 scale) was used to define tiredness subgroups. Patients were stratified into 3 subgroups: mild (0 to 3), moderate (4 to 6), and severe (7 to 10) tiredness. Analysis of covariance models and logistic regressions were used to test treatment-by-tiredness subgroup interactions.Results: Data from the first 3 months are included in this post hoc analysis (duloxetine N = 797, placebo N = 535). At baseline, the distribution of tiredness severity in the duloxetine and placebo groups respectively was 3.64% and 3.75% mild, 16.71% and 15.57% moderate, and 79.65% and 80.68% severe. Rates of clinically significant (≥30% and ≥50%) improvement in brief pain inventory (BPI) average pain were similar across the tiredness subgroups. Tiredness severity at baseline was not negatively associated with the effects of duloxetine on patients' reports of functional ability using the FIQ total score, FIQ measures of physical impairment, interference with work, pain, stiffness, and depression and the medical outcomes study short form-36 (SF-36).Conclusions: Studies of duloxetine in fibromyalgia have demonstrated clinically significant improvements in pain and functional ability (FIQ, SF-36). This post hoc analysis of data shows that the efficacy of duloxetine among patients with fibromyalgia does not vary as a function of baseline ratings of fatigue/tiredness.
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U2 - 10.1186/ar3081
DO - 10.1186/ar3081
M3 - Article
C2 - 20630058
AN - SCOPUS:77954478303
SN - 1478-6354
VL - 12
JO - Arthritis Research and Therapy
JF - Arthritis Research and Therapy
IS - 4
M1 - R141
ER -