Does Treatment With Duloxetine for Neuropathic Pain Impact Glycemic Control?

OBJECTIVE:--We examined changes in metabolic parameters in clinical trials of duloxetine for diabetic peripheral neuropathic pain (DPNP). RESEARCH DESIGN AND METHODS--Data were pooled from three similarly designed clinical trials. Adults with diabetes and DPNP (n = 1,024) were randomized to 60 mg du...

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Veröffentlicht in:Diabetes care 2007, Vol.30 (1), p.21-26
Hauptverfasser: Hardy, Thomas, Sachson, Richard, Shen, Shuyi, Armbruster, Mary, Boulton, Andrew J.M
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creator Hardy, Thomas
Sachson, Richard
Shen, Shuyi
Armbruster, Mary
Boulton, Andrew J.M
description OBJECTIVE:--We examined changes in metabolic parameters in clinical trials of duloxetine for diabetic peripheral neuropathic pain (DPNP). RESEARCH DESIGN AND METHODS--Data were pooled from three similarly designed clinical trials. Adults with diabetes and DPNP (n = 1,024) were randomized to 60 mg duloxetine q.d., 60 mg b.i.d., or placebo for 12 weeks. Subjects (n = 867) were re-randomized to 60 mg duloxetine b.i.d. or routine care for an additional 52 weeks. Mean changes in plasma glucose, lipids, and weight were evaluated. Regression and subgroup analyses were used to identify relationships between metabolic measures and demographic, clinical, and electrophysiological parameters. RESULTS:--Duloxetine treatment resulted in modest increases in fasting plasma glucose in short- and long-term studies (0.50 and 0.67 mmol/l, respectively). A1C did not increase in placebo-controlled studies; however, a greater increase was seen relative to routine care in long-term studies (0.52 vs. 0.19%). Short-term duloxetine treatment resulted in mean weight loss (-1.03 kg; P < 0.001 vs. placebo), whereas slight, nonsignificant weight gain was seen in both duloxetine and routine care groups with longer treatment. Between-group differences were seen for some lipid parameters, but these changes were generally small. Metabolic changes did not appear to impact improvement in pain severity seen with duloxetine, and nerve conduction was also not significantly impacted by treatment. CONCLUSIONS:--Duloxetine treatment was associated with modest changes in glycemia in patients with DPNP. Other metabolic changes were limited and of uncertain significance. These changes did not impact the significant improvement in pain observed with duloxetine treatment.
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RESEARCH DESIGN AND METHODS--Data were pooled from three similarly designed clinical trials. Adults with diabetes and DPNP (n = 1,024) were randomized to 60 mg duloxetine q.d., 60 mg b.i.d., or placebo for 12 weeks. Subjects (n = 867) were re-randomized to 60 mg duloxetine b.i.d. or routine care for an additional 52 weeks. Mean changes in plasma glucose, lipids, and weight were evaluated. Regression and subgroup analyses were used to identify relationships between metabolic measures and demographic, clinical, and electrophysiological parameters. RESULTS:--Duloxetine treatment resulted in modest increases in fasting plasma glucose in short- and long-term studies (0.50 and 0.67 mmol/l, respectively). A1C did not increase in placebo-controlled studies; however, a greater increase was seen relative to routine care in long-term studies (0.52 vs. 0.19%). Short-term duloxetine treatment resulted in mean weight loss (-1.03 kg; P &lt; 0.001 vs. placebo), whereas slight, nonsignificant weight gain was seen in both duloxetine and routine care groups with longer treatment. Between-group differences were seen for some lipid parameters, but these changes were generally small. Metabolic changes did not appear to impact improvement in pain severity seen with duloxetine, and nerve conduction was also not significantly impacted by treatment. CONCLUSIONS:--Duloxetine treatment was associated with modest changes in glycemia in patients with DPNP. Other metabolic changes were limited and of uncertain significance. These changes did not impact the significant improvement in pain observed with duloxetine treatment.</description><identifier>ISSN: 0149-5992</identifier><identifier>EISSN: 1935-5548</identifier><identifier>DOI: 10.2337/dc06-0947</identifier><identifier>PMID: 17192327</identifier><identifier>CODEN: DICAD2</identifier><language>eng</language><publisher>Alexandria, VA: American Diabetes Association</publisher><subject>Adult ; Biological and medical sciences ; Blood Glucose - drug effects ; Blood Glucose - metabolism ; Changes ; Clinical trials ; Clinical Trials as Topic ; Complications and side effects ; Cranial nerves. Spinal roots. Peripheral nerves. Autonomic nervous system. Gustation. Olfaction ; Data analysis ; Design ; Diabetes ; Diabetes Mellitus, Type 1 - blood ; Diabetes Mellitus, Type 1 - physiopathology ; Diabetes Mellitus, Type 2 - blood ; Diabetes Mellitus, Type 2 - physiopathology ; Diabetes. 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RESEARCH DESIGN AND METHODS--Data were pooled from three similarly designed clinical trials. Adults with diabetes and DPNP (n = 1,024) were randomized to 60 mg duloxetine q.d., 60 mg b.i.d., or placebo for 12 weeks. Subjects (n = 867) were re-randomized to 60 mg duloxetine b.i.d. or routine care for an additional 52 weeks. Mean changes in plasma glucose, lipids, and weight were evaluated. Regression and subgroup analyses were used to identify relationships between metabolic measures and demographic, clinical, and electrophysiological parameters. RESULTS:--Duloxetine treatment resulted in modest increases in fasting plasma glucose in short- and long-term studies (0.50 and 0.67 mmol/l, respectively). A1C did not increase in placebo-controlled studies; however, a greater increase was seen relative to routine care in long-term studies (0.52 vs. 0.19%). Short-term duloxetine treatment resulted in mean weight loss (-1.03 kg; P &lt; 0.001 vs. placebo), whereas slight, nonsignificant weight gain was seen in both duloxetine and routine care groups with longer treatment. Between-group differences were seen for some lipid parameters, but these changes were generally small. Metabolic changes did not appear to impact improvement in pain severity seen with duloxetine, and nerve conduction was also not significantly impacted by treatment. CONCLUSIONS:--Duloxetine treatment was associated with modest changes in glycemia in patients with DPNP. Other metabolic changes were limited and of uncertain significance. These changes did not impact the significant improvement in pain observed with duloxetine treatment.</description><subject>Adult</subject><subject>Biological and medical sciences</subject><subject>Blood Glucose - drug effects</subject><subject>Blood Glucose - metabolism</subject><subject>Changes</subject><subject>Clinical trials</subject><subject>Clinical Trials as Topic</subject><subject>Complications and side effects</subject><subject>Cranial nerves. Spinal roots. Peripheral nerves. Autonomic nervous system. Gustation. Olfaction</subject><subject>Data analysis</subject><subject>Design</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 1 - blood</subject><subject>Diabetes Mellitus, Type 1 - physiopathology</subject><subject>Diabetes Mellitus, Type 2 - blood</subject><subject>Diabetes Mellitus, Type 2 - physiopathology</subject><subject>Diabetes. Impaired glucose tolerance</subject><subject>Diabetic neuropathies</subject><subject>Diabetic Neuropathies - drug therapy</subject><subject>Diabetic neuropathy</subject><subject>Diagnosis</subject><subject>Double-Blind Method</subject><subject>Drug therapy</subject><subject>Duloxetine Hydrochloride</subject><subject>Endocrine pancreas. 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RESEARCH DESIGN AND METHODS--Data were pooled from three similarly designed clinical trials. Adults with diabetes and DPNP (n = 1,024) were randomized to 60 mg duloxetine q.d., 60 mg b.i.d., or placebo for 12 weeks. Subjects (n = 867) were re-randomized to 60 mg duloxetine b.i.d. or routine care for an additional 52 weeks. Mean changes in plasma glucose, lipids, and weight were evaluated. Regression and subgroup analyses were used to identify relationships between metabolic measures and demographic, clinical, and electrophysiological parameters. RESULTS:--Duloxetine treatment resulted in modest increases in fasting plasma glucose in short- and long-term studies (0.50 and 0.67 mmol/l, respectively). A1C did not increase in placebo-controlled studies; however, a greater increase was seen relative to routine care in long-term studies (0.52 vs. 0.19%). Short-term duloxetine treatment resulted in mean weight loss (-1.03 kg; P &lt; 0.001 vs. placebo), whereas slight, nonsignificant weight gain was seen in both duloxetine and routine care groups with longer treatment. Between-group differences were seen for some lipid parameters, but these changes were generally small. Metabolic changes did not appear to impact improvement in pain severity seen with duloxetine, and nerve conduction was also not significantly impacted by treatment. CONCLUSIONS:--Duloxetine treatment was associated with modest changes in glycemia in patients with DPNP. Other metabolic changes were limited and of uncertain significance. These changes did not impact the significant improvement in pain observed with duloxetine treatment.</abstract><cop>Alexandria, VA</cop><pub>American Diabetes Association</pub><pmid>17192327</pmid><doi>10.2337/dc06-0947</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record>
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source MEDLINE; EZB-FREE-00999 freely available EZB journals
subjects Adult
Biological and medical sciences
Blood Glucose - drug effects
Blood Glucose - metabolism
Changes
Clinical trials
Clinical Trials as Topic
Complications and side effects
Cranial nerves. Spinal roots. Peripheral nerves. Autonomic nervous system. Gustation. Olfaction
Data analysis
Design
Diabetes
Diabetes Mellitus, Type 1 - blood
Diabetes Mellitus, Type 1 - physiopathology
Diabetes Mellitus, Type 2 - blood
Diabetes Mellitus, Type 2 - physiopathology
Diabetes. Impaired glucose tolerance
Diabetic neuropathies
Diabetic Neuropathies - drug therapy
Diabetic neuropathy
Diagnosis
Double-Blind Method
Drug therapy
Duloxetine Hydrochloride
Endocrine pancreas. Apud cells (diseases)
Endocrinopathies
Female
Foot diseases
Glycated Hemoglobin A - analysis
Humans
Hyperglycemia
Lipids - blood
Male
Medical sciences
Middle Aged
Nervous system (semeiology, syndromes)
Neuritis - drug therapy
Neurology
Placebos
Randomized Controlled Trials as Topic
Regulatory approval
Risk factors
Serotonin Uptake Inhibitors - therapeutic use
Thiophenes - therapeutic use
Weight control
title Does Treatment With Duloxetine for Neuropathic Pain Impact Glycemic Control?
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