Duloxetine vs. placebo in patients with painful diabetic neuropathy

• Published in: Pain (Amsterdam) Vol. 116; no. 1; pp. 109 - 118
• Main Authors: Goldstein, David J., Lu, Yili, Detke, Michael J., Lee, Thomas C., Iyengar, Smriti
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier B.V 01-07-2005; Elsevier
• Subjects: Aged; Antidepressant; Biological and medical sciences; Cranial nerves. Spinal roots. Peripheral nerves. Autonomic nervous system. Gustation. Olfaction; Cymbalta; Demography; Depression - drug therapy; Depression - etiology; Diabetic Neuropathies - blood; Diabetic Neuropathies - complications; Diabetic Neuropathies - drug therapy; Diabetic Neuropathies - urine; Diabetic neuropathy; Dose-Response Relationship, Drug; Double-Blind Method; Duloxetine; Duloxetine Hydrochloride; Efficacy; Female; Fundamental and applied biological sciences. Psychology; Humans; Illness and personality; Illness, stress and coping; Male; Medical sciences; Middle Aged; Nervous system (semeiology, syndromes); Neurology; Pain; Pain Measurement - drug effects; Pain Measurement - methods; Personality Inventory; Placebos - therapeutic use; Psychology and medicine; Psychology. Psychoanalysis. Psychiatry; Psychology. Psychophysiology; Safety/tolerability; Serotonin Uptake Inhibitors - blood; Serotonin Uptake Inhibitors - therapeutic use; Serotonin Uptake Inhibitors - urine; Thiophenes - blood; Thiophenes - therapeutic use; Thiophenes - urine; Treatment Outcome; Cymbalta; Antidepressant; Safety/tolerability; Pain; Diabetic neuropathy; Efficacy; Duloxetine; Endocrinopathy; Multicenter study; Autoimmune disease; Reuptake inhibitor; Peripheral neuropathy; Polyneuropathy; Improvement; Randomization; Peripheral nerve disease; Diagnosis; Safety; Human; Immunopathology; Nervous system diseases; Serotonin; Catecholamine; Treatment; Type 1 diabetes; Placebo; Neurotransmitter; Norepinephrine
• ISSN: 0304-3959; 1872-6623
• DOI: 10.1016/j.pain.2005.03.029

The aim of this study was to examine the efficacy and safety of duloxetine, a balanced and potent dual reuptake inhibitor of serotonin and norepinephrine, in the management of diabetic peripheral neuropathic pain. Serotonin and norepinephrine are thought to inhibit pain via descending pain pathways. In a 12-week, multicenter, double-blind study, 457 patients experiencing pain due to polyneuropathy caused by Type 1 or Type 2 diabetes mellitus were randomly assigned to treatment with duloxetine 20
mg/d (20
mg QD), 60
mg/d (60
mg QD), 120
mg/d (60
mg BID), or placebo. The diagnosis was confirmed by a score of at least 3 on the Michigan Neuropathy Screening Instrument. The primary efficacy measure was the weekly mean score of the 24-h Average Pain Score, which was rated on an 11-point (0–10) Likert scale (no pain to worst possible pain) and computed from diary scores between two site visits. Duloxetine 60 and 120
mg/d demonstrated statistically significant greater improvement compared with placebo on the 24-h Average Pain Score, beginning 1 week after randomization and continuing through the 12-week trial. Duloxetine also separated from placebo on nearly all the secondary measures including health-related outcome measures. Significantly more patients in all three active-treatment groups achieved a 50% reduction in the 24-h Average Pain Score compared with placebo. Duloxetine treatment was considered to be safe and well tolerated with less than 20 percent discontinuation due to adverse events. Duloxetine at 60 and 120
mg/d was safe and effective in the management of diabetic peripheral neuropathic pain.