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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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 < 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. 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</subject><ispartof>Diabetes care, 2007, Vol.30 (1), p.21-26</ispartof><rights>2007 INIST-CNRS</rights><rights>COPYRIGHT 2007 American Diabetes Association</rights><rights>Copyright American Diabetes Association Jan 2007</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c509t-543f01b86d41e2cdcef8bddaff055ee8cdc2a3d834ccbb77e7bdc6879c0edc6a3</citedby><cites>FETCH-LOGICAL-c509t-543f01b86d41e2cdcef8bddaff055ee8cdc2a3d834ccbb77e7bdc6879c0edc6a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,782,786,4026,27930,27931,27932</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=18439506$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17192327$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hardy, Thomas</creatorcontrib><creatorcontrib>Sachson, Richard</creatorcontrib><creatorcontrib>Shen, Shuyi</creatorcontrib><creatorcontrib>Armbruster, Mary</creatorcontrib><creatorcontrib>Boulton, Andrew J.M</creatorcontrib><title>Does Treatment With Duloxetine for Neuropathic Pain Impact Glycemic Control?</title><title>Diabetes care</title><addtitle>Diabetes Care</addtitle><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.</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. Apud cells (diseases)</subject><subject>Endocrinopathies</subject><subject>Female</subject><subject>Foot diseases</subject><subject>Glycated Hemoglobin A - analysis</subject><subject>Humans</subject><subject>Hyperglycemia</subject><subject>Lipids - blood</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nervous system (semeiology, syndromes)</subject><subject>Neuritis - drug therapy</subject><subject>Neurology</subject><subject>Placebos</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Regulatory approval</subject><subject>Risk factors</subject><subject>Serotonin Uptake Inhibitors - therapeutic use</subject><subject>Thiophenes - therapeutic use</subject><subject>Weight control</subject><issn>0149-5992</issn><issn>1935-5548</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNpt0V9rFDEQAPAgij2rD34BXQRFH7bmz2Y3eZJy1Vo4VLDFx5BNJncpu5szyaL99ma5g4KUPCQMvxkmMwi9JPiMMtZ9tAa3NZZN9witiGS85rwRj9EKk0bWXEp6gp6ldIsxbhohnqIT0hFJGe1WaHMRIFXXEXQeYcrVL5931cU8hL-Q_QSVC7H6BnMMe5133lQ_tJ-qq3GvTa4uhzsDYwmuw5RjGD49R0-cHhK8ON6n6ObL5-v113rz_fJqfb6pDccy17xhDpNetLYhQI014ERvrXYOcw4gSoRqZgVrjOn7roOut6YVnTQYykOzU_TuUHcfw-8ZUlajTwaGQU8Q5qRawTpBZVvgm__gbZjjVHpTlDLMaUsXVB_QVg-g_ORCjtpsYYKohzCB8yV8TrggZXhdU_zZA74cuwzjwYQPhwQTQ0oRnNpHP-p4pwhWywLVskC1LLDYV8eO534Eey-PGyvg7RHoZPTgop6MT_dONExyvPzq_cHt_Hb3x0dQ1useMqTlYXQJMKyIoqTQ1wfqdFB6G0u5m58UE4YJoZwIyf4By6G5qQ</recordid><startdate>2007</startdate><enddate>2007</enddate><creator>Hardy, Thomas</creator><creator>Sachson, Richard</creator><creator>Shen, Shuyi</creator><creator>Armbruster, Mary</creator><creator>Boulton, Andrew J.M</creator><general>American Diabetes Association</general><scope>FBQ</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0K</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M2P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>S0X</scope><scope>7X8</scope></search><sort><creationdate>2007</creationdate><title>Does Treatment With Duloxetine for Neuropathic Pain Impact Glycemic Control?</title><author>Hardy, Thomas ; Sachson, Richard ; Shen, Shuyi ; Armbruster, Mary ; Boulton, Andrew J.M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c509t-543f01b86d41e2cdcef8bddaff055ee8cdc2a3d834ccbb77e7bdc6879c0edc6a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Adult</topic><topic>Biological and medical sciences</topic><topic>Blood Glucose - drug effects</topic><topic>Blood Glucose - metabolism</topic><topic>Changes</topic><topic>Clinical trials</topic><topic>Clinical Trials as Topic</topic><topic>Complications and side effects</topic><topic>Cranial nerves. Spinal roots. Peripheral nerves. Autonomic nervous system. Gustation. Olfaction</topic><topic>Data analysis</topic><topic>Design</topic><topic>Diabetes</topic><topic>Diabetes Mellitus, Type 1 - blood</topic><topic>Diabetes Mellitus, Type 1 - physiopathology</topic><topic>Diabetes Mellitus, Type 2 - blood</topic><topic>Diabetes Mellitus, Type 2 - physiopathology</topic><topic>Diabetes. Impaired glucose tolerance</topic><topic>Diabetic neuropathies</topic><topic>Diabetic Neuropathies - drug therapy</topic><topic>Diabetic neuropathy</topic><topic>Diagnosis</topic><topic>Double-Blind Method</topic><topic>Drug therapy</topic><topic>Duloxetine Hydrochloride</topic><topic>Endocrine pancreas. Apud cells (diseases)</topic><topic>Endocrinopathies</topic><topic>Female</topic><topic>Foot diseases</topic><topic>Glycated Hemoglobin A - analysis</topic><topic>Humans</topic><topic>Hyperglycemia</topic><topic>Lipids - blood</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Nervous system (semeiology, syndromes)</topic><topic>Neuritis - drug therapy</topic><topic>Neurology</topic><topic>Placebos</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Regulatory approval</topic><topic>Risk factors</topic><topic>Serotonin Uptake Inhibitors - therapeutic use</topic><topic>Thiophenes - therapeutic use</topic><topic>Weight control</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hardy, Thomas</creatorcontrib><creatorcontrib>Sachson, Richard</creatorcontrib><creatorcontrib>Shen, Shuyi</creatorcontrib><creatorcontrib>Armbruster, Mary</creatorcontrib><creatorcontrib>Boulton, Andrew J.M</creatorcontrib><collection>AGRIS</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Agricultural Science Collection</collection><collection>ProQuest Health and Medical</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>Agricultural & Environmental Science Collection</collection><collection>ProQuest Central Essentials</collection><collection>eLibrary</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Agricultural Science Database</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>ProQuest Health Management</collection><collection>Medical Database</collection><collection>ProQuest Research Library</collection><collection>ProQuest Science Journals</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><jtitle>Diabetes care</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hardy, Thomas</au><au>Sachson, Richard</au><au>Shen, Shuyi</au><au>Armbruster, Mary</au><au>Boulton, Andrew J.M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Does Treatment With Duloxetine for Neuropathic Pain Impact Glycemic Control?</atitle><jtitle>Diabetes care</jtitle><addtitle>Diabetes Care</addtitle><date>2007</date><risdate>2007</risdate><volume>30</volume><issue>1</issue><spage>21</spage><epage>26</epage><pages>21-26</pages><issn>0149-5992</issn><eissn>1935-5548</eissn><coden>DICAD2</coden><abstract>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.</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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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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