Abstract
The primary objective of this study is to review the efficacy of duloxetine in treating chronic pain using the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations for clinical significance across chronic pain states. These include pain intensity, patient ratings of overall improvement, physical functioning, and mental functioning. This review comprised the side-by-side analyses of 12 double-blind, placebo-controlled trials of duloxetine in patients with chronic pain (diabetic peripheral neuropathic pain, fibromyalgia, chronic pain due to osteoarthritis, and chronic low back pain). Patients received duloxetine (60 to 120 mg/day) or placebo. Average pain reduction was assessed over 3 months as the primary efficacy outcome. Other measures used were physical function and Patient Global Impression of Improvement. In 10 of the 12 studies, statistically significant greater pain reduction was observed for duloxetine- compared with placebo-treated patients. The response rates based on average pain reduction, improvement of physical function, and global impression were comparable across all 4 chronic pain states. Compared with patients on placebo, significantly more patients treated with duloxetine reported a moderately important pain reduction (≥30% reduction) in 9 of the 12 studies, a minimally important improvement in physical function in 8 of the 12 studies, and a moderately important to substantial improvement in Patient Global Impression of Improvement rating in 11 of the 12 studies. The analyses reported here show that duloxetine is efficacious in treating chronic pain as demonstrated by significant improvement in pain intensity, physical functioning, and patient ratings of overall improvement.
Highlights
IntroductionThe prevalence of chronic pain in the United States and Europe has been estimated at 35.5% [1] and 19% (of adults with moderate to severe intensity) [2], respectively
The prevalence of chronic pain in the United States and Europe has been estimated at 35.5% [1] and 19% [2], respectively
Baseline refers to the last nonmissing observation at or before the random assignment visit and endpoint refers to the last nonmissing observation in the 3month treatment phase [last observation carried forward (LOCF)]
Summary
The prevalence of chronic pain in the United States and Europe has been estimated at 35.5% [1] and 19% (of adults with moderate to severe intensity) [2], respectively. Unlike acute (nociceptive) pain, chronic pain is a pathological state associated with functional and structural changes within the peripheral and central nervous systems. Among these changes, central sensitization and impairment of associated pain inhibitory circuits have been extensively researched [9,10,11,12]. These pathophysiological mechanisms are involved in and at least partially responsible for the development and maintenance of chronic pain states, regardless of their respective underlying etiologies (e.g., neuropathy, inflammation, or tissue damage)
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