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Review of duloxetine in the management of diabetic peripheral neuropathic pain.

Smith T, Nicholson RA - Vasc Health Risk Manag (2007)

Bottom Line: This compound has no other significant receptor or channel activities other than the serotonin and norepinephrine reuptake inhibition mechanisms and works to diminish or control the symptoms of diabetic neuropathy.Duloxetine has no known neuroprotective or other effects which prevent the development of neuropathy in patients with diabetes.These findings provide support for the proposed role of serotonin and norepinephrine as key mediators of the descending pain inhibition pathways of the brain stem and spinal cord.

View Article: PubMed Central - PubMed

Affiliation: Mercy Health Research, Ryan Headache Center, St. Louis, MO 63141, USA. tsmith@stlo.mercy.net

ABSTRACT
Duloxetine is a balanced selective serotonin norepinephrine reuptake inhibitor (SNRI) which, in 2004, became the first agent to receive regulatory approval for the treatment of painful diabetic neuropathy in the US. This compound has no other significant receptor or channel activities other than the serotonin and norepinephrine reuptake inhibition mechanisms and works to diminish or control the symptoms of diabetic neuropathy. Duloxetine has no known neuroprotective or other effects which prevent the development of neuropathy in patients with diabetes. The purpose of this review article is to discuss the background of painful diabetic neuropathy, the pharmacology of duloxetine, and its safety and efficacy in clinical trials and long-term observations. The authors will also comment on its use in clinical practice. Results from controlled clinical trials reveal that duloxetine administered at 60 mg qd or 60 mg bid is efficacious in treating diabetic neuropathic pain relative to placebo. Positive treatment outcomes are also seen for other measures of pain and quality of life. A minor but statistically significant increase in blood glucose compared with placebo treated patients has been observed in controlled clinical trials. Otherwise, controlled and open-label clinical studies have demonstrated a high degree of safety and tolerability for the compound. These findings provide support for the proposed role of serotonin and norepinephrine as key mediators of the descending pain inhibition pathways of the brain stem and spinal cord.

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Primary efficacy measure (24 hour average pain severity score) in duloxetine-treated patients with pain associated with diabetic neuropathy. Reproduced with permission from Goldstein D, Lu Y, Detke MJ et al 2005. Duloxetine vs. placebo in patients with painful diabetic neuropathy. Pain, 116:109–18. Copyright © IASP®.
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fig2: Primary efficacy measure (24 hour average pain severity score) in duloxetine-treated patients with pain associated with diabetic neuropathy. Reproduced with permission from Goldstein D, Lu Y, Detke MJ et al 2005. Duloxetine vs. placebo in patients with painful diabetic neuropathy. Pain, 116:109–18. Copyright © IASP®.

Mentions: Table 1 shows the baseline characteristics of patients for all studies. A total of 77.8% of subjects completed the trials. Figure 2 shows that in all 3 trials, subjects in the duloxetine 60 mg qd or 60 mg bid treatment arm reported a greater decrease in 24-hour average pain severity relative to placebo after the first week and this effect was maintained throughout the 12-week dosing period. In the Goldstein et al (2005) trial, subjects in the 20 mg arm did not show significant pain reduction relative to placebo. Figure 2 also shows that in all 3 studies, the reduction in 24-hour average pain severity was consistent with a dose dependent response.


Review of duloxetine in the management of diabetic peripheral neuropathic pain.

Smith T, Nicholson RA - Vasc Health Risk Manag (2007)

Primary efficacy measure (24 hour average pain severity score) in duloxetine-treated patients with pain associated with diabetic neuropathy. Reproduced with permission from Goldstein D, Lu Y, Detke MJ et al 2005. Duloxetine vs. placebo in patients with painful diabetic neuropathy. Pain, 116:109–18. Copyright © IASP®.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2350145&req=5

fig2: Primary efficacy measure (24 hour average pain severity score) in duloxetine-treated patients with pain associated with diabetic neuropathy. Reproduced with permission from Goldstein D, Lu Y, Detke MJ et al 2005. Duloxetine vs. placebo in patients with painful diabetic neuropathy. Pain, 116:109–18. Copyright © IASP®.
Mentions: Table 1 shows the baseline characteristics of patients for all studies. A total of 77.8% of subjects completed the trials. Figure 2 shows that in all 3 trials, subjects in the duloxetine 60 mg qd or 60 mg bid treatment arm reported a greater decrease in 24-hour average pain severity relative to placebo after the first week and this effect was maintained throughout the 12-week dosing period. In the Goldstein et al (2005) trial, subjects in the 20 mg arm did not show significant pain reduction relative to placebo. Figure 2 also shows that in all 3 studies, the reduction in 24-hour average pain severity was consistent with a dose dependent response.

Bottom Line: This compound has no other significant receptor or channel activities other than the serotonin and norepinephrine reuptake inhibition mechanisms and works to diminish or control the symptoms of diabetic neuropathy.Duloxetine has no known neuroprotective or other effects which prevent the development of neuropathy in patients with diabetes.These findings provide support for the proposed role of serotonin and norepinephrine as key mediators of the descending pain inhibition pathways of the brain stem and spinal cord.

View Article: PubMed Central - PubMed

Affiliation: Mercy Health Research, Ryan Headache Center, St. Louis, MO 63141, USA. tsmith@stlo.mercy.net

ABSTRACT
Duloxetine is a balanced selective serotonin norepinephrine reuptake inhibitor (SNRI) which, in 2004, became the first agent to receive regulatory approval for the treatment of painful diabetic neuropathy in the US. This compound has no other significant receptor or channel activities other than the serotonin and norepinephrine reuptake inhibition mechanisms and works to diminish or control the symptoms of diabetic neuropathy. Duloxetine has no known neuroprotective or other effects which prevent the development of neuropathy in patients with diabetes. The purpose of this review article is to discuss the background of painful diabetic neuropathy, the pharmacology of duloxetine, and its safety and efficacy in clinical trials and long-term observations. The authors will also comment on its use in clinical practice. Results from controlled clinical trials reveal that duloxetine administered at 60 mg qd or 60 mg bid is efficacious in treating diabetic neuropathic pain relative to placebo. Positive treatment outcomes are also seen for other measures of pain and quality of life. A minor but statistically significant increase in blood glucose compared with placebo treated patients has been observed in controlled clinical trials. Otherwise, controlled and open-label clinical studies have demonstrated a high degree of safety and tolerability for the compound. These findings provide support for the proposed role of serotonin and norepinephrine as key mediators of the descending pain inhibition pathways of the brain stem and spinal cord.

Show MeSH
Related in: MedlinePlus