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24th Annual Meeting
February 13-16, 2008
Orlando, FL
© 2006 American Academy of Pain Medicine
 


Thursday, February 14, 2008
109

The Safety and Efficacy of Duloxetine Hydrochloride for the Treatment of Fibromyalgia: Results from a 6-month Randomized, Double-Blind, Placebo-Controlled, Fixed-Dosed Trial

Madelaine Wohlreich, MD1, I. Jon Russell, MD2, Philip Mease, MD3, Timothy R. Smith4, Daniel K. Kajdasz, PhD1, Daniel Walker, PhD1, Wahiba Estergard, PharmD1, and Amy Chappell, MD1. (1) Eli Lilly and Company, Indianapolis, IN, USA, (2) University of Texas Health Science Center, San Antonio, TX, USA, (3) Seattle Rheumatology Associates and Swedish Medical Center, Seattle, WA, USA, (4) Washington University School of Medicine, Chesterfield, MO, USA

Objectives: The primary objective was to determine whether treatment with duloxetine (DLX) 120 mg/d for 3 months was effective in reducing pain severity in patients with fibromyalgia syndrome (FMS).

Methods: DLX60 mg/d, DLX120 mg/d, and placebo (PBO) were compared during 6 months of treatment in adults with American College of Rheumatology-defined primary FMS. Coprimary efficacy measures included the Brief Pain Inventory Average Pain Score (APS), and the Patients Global Impressions of Improvement (PGI-I) questionnaire. Safety and tolerability were assessed.

Results: At 3 months, patients treated with DLX120 mg/d showed greater improvement in change from baseline in APS score (-2.31 vs -1.38, P<.001) and endpoint PGI-I score (2.89 vs 3.39, P=.004) vs PBO-treated patients. At 6 months, the DLX120 mg/d group still exhibited greater improvement in APS change (-2.25 vs -1.42, P=.003) and PGI-I (2.93 vs 3.37, P=.012). The DLX60 mg/d group showed significant improvement compared with PBO on both measures at 3 months and on APS change at 6 months. At 6 months, response, defined as ≥50% reduction from baseline in APS, was greater with DLX120 mg/d (35.9%, P≤.01) and DLX60 mg/d (32.6%, P≤.05) vs PBO (21.6%). DLX was similarly efficacious in patients with (N=122) or without (N=375) major depressive disorder (MDD) with regard to both co-primaries. Discontinuation rates over 6 months were similar among the groups (DLX60 mg/d 45.3%, DLX120 mg/d 46.3%, PBO 50.0%). Adverse event-related discontinuation was significantly higher in the DLX120 mg/d (25.9%, P=.003) but not in the DLX60 mg/d (15.3%, P=.400) group compared with the PBO (11.8%) group.

Conclusions: DLX60 and DLX120 mg/d are efficacious and safe treatment options for pain associated with FMS, whether or not MDD is present.


References: Arnold LM, Lu Y, Crofford LJ, Wohlreich M, Detke MJ, Iyengar S, et al. A double-blind, multicenter trial comparing duloxetine with placebo in the treatment of fibromyalgia patients with or without major depressive disorder. Arthritis Rheum 2004;50:2974–84.

Arnold LM, Rosen A, Pritchett YL, D'Souza DN, Goldstein DJ, Iyengar S, et al. A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder. Pain 2005;119:5–15.
Funding: Funding provided by Eli Lilly and Company and Boehringer Ingelheim

Wahiba Estergard, PharmD
Conflict of Interest Disclosure: Eli Lilly and Company, employee

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