Effects of Growth Hormone on Abnormal Visceral Adipose Tissue Accumulation and Dyslipidemia in HIV-Infected Patients

BACKGROUNDSome HIV-infected patients develop fat maldistribution with visceral adipose tissue (VAT) accumulation and metabolic abnormalities. No medical treatment is approved by the US Food and Drug Administration to reduce VAT. METHODSIn this double-blind trial, 245 HIV-infected patients with exces...

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Veröffentlicht in:Journal of acquired immune deficiency syndromes (1999) 2004-03, Vol.35 (3), p.239-252
Hauptverfasser: Kotler, Donald P, Muurahainen, Norma, Grunfeld, Carl, Wanke, Christine, Thompson, Melanie, Saag, Michael, Bock, Daena, Simons, Gregg, Gertner, Joseph M
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container_end_page 252
container_issue 3
container_start_page 239
container_title Journal of acquired immune deficiency syndromes (1999)
container_volume 35
creator Kotler, Donald P
Muurahainen, Norma
Grunfeld, Carl
Wanke, Christine
Thompson, Melanie
Saag, Michael
Bock, Daena
Simons, Gregg
Gertner, Joseph M
description BACKGROUNDSome HIV-infected patients develop fat maldistribution with visceral adipose tissue (VAT) accumulation and metabolic abnormalities. No medical treatment is approved by the US Food and Drug Administration to reduce VAT. METHODSIn this double-blind trial, 245 HIV-infected patients with excess VAT were randomized to receive placebo (PL), recombinant human growth hormone (r-hGH) at a dose of 4 mg daily (DD) or 4 mg on alternate days (AD) for 12 weeks. For weeks 12 to 24, DD patients were rerandomized to PL (DD-PL) or AD (DD-AD), AD patients continued on AD (AD-AD), and PL patients were switched to DD (PL-DD). RESULTSFrom baseline to week 12, VAT decreased significantly compared with PL in DD (−8.6%, P < 0.001) but not in AD (−4.2%, P = 0.052). Trunk-to-limb fat ratio decreased significantly in both (P < 0.001) compared with PL, as did total cholesterol and non–high-density lipoprotein (HDL) cholesterol (−4.5% and −7.5% in DD, −4.3% and −6.2% in AD). At week 24, all groups displayed significant (P < 0.05) reductions in VAT (−5.3% to −9.5%) and trunk fat (−7.8% to −22.8%). DD-AD and AD-AD also displayed significant (P < 0.05) reductions in non-HDL cholesterol. CONCLUSIONSThese results suggest that r-hGH dosed at 4 mg daily for 12 weeks decreases VAT and cholesterol concentrations in HIV-infected patients with excess VAT. The optimal regimen to sustain these effects awaits determination.
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No medical treatment is approved by the US Food and Drug Administration to reduce VAT. METHODSIn this double-blind trial, 245 HIV-infected patients with excess VAT were randomized to receive placebo (PL), recombinant human growth hormone (r-hGH) at a dose of 4 mg daily (DD) or 4 mg on alternate days (AD) for 12 weeks. For weeks 12 to 24, DD patients were rerandomized to PL (DD-PL) or AD (DD-AD), AD patients continued on AD (AD-AD), and PL patients were switched to DD (PL-DD). RESULTSFrom baseline to week 12, VAT decreased significantly compared with PL in DD (−8.6%, P &lt; 0.001) but not in AD (−4.2%, P = 0.052). Trunk-to-limb fat ratio decreased significantly in both (P &lt; 0.001) compared with PL, as did total cholesterol and non–high-density lipoprotein (HDL) cholesterol (−4.5% and −7.5% in DD, −4.3% and −6.2% in AD). At week 24, all groups displayed significant (P &lt; 0.05) reductions in VAT (−5.3% to −9.5%) and trunk fat (−7.8% to −22.8%). DD-AD and AD-AD also displayed significant (P &lt; 0.05) reductions in non-HDL cholesterol. CONCLUSIONSThese results suggest that r-hGH dosed at 4 mg daily for 12 weeks decreases VAT and cholesterol concentrations in HIV-infected patients with excess VAT. The optimal regimen to sustain these effects awaits determination.</description><identifier>ISSN: 1525-4135</identifier><identifier>EISSN: 1944-7884</identifier><identifier>DOI: 10.1097/00126334-200403010-00004</identifier><identifier>PMID: 15076238</identifier><identifier>CODEN: JDSRET</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams &amp; Wilkins, Inc</publisher><subject>Adipose Tissue - anatomy &amp; histology ; Adipose Tissue - drug effects ; Adolescent ; Adult ; AIDS/HIV ; Anti-HIV Agents - therapeutic use ; Biological and medical sciences ; Body fat ; Cholesterol - blood ; Continental Population Groups ; Double-Blind Method ; Drug Administration Schedule ; Drug therapy ; Female ; Fundamental and applied biological sciences. Psychology ; HIV ; HIV Infections - blood ; HIV Infections - drug therapy ; HIV Infections - physiopathology ; Hormones ; Human Growth Hormone - administration &amp; dosage ; Human Growth Hormone - therapeutic use ; Human immunodeficiency virus ; Human viral diseases ; Humans ; Hyperlipidemias - drug therapy ; Infectious diseases ; Male ; Medical sciences ; Microbiology ; Middle Aged ; Miscellaneous ; Placebos ; Reproducibility of Results ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. 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No medical treatment is approved by the US Food and Drug Administration to reduce VAT. METHODSIn this double-blind trial, 245 HIV-infected patients with excess VAT were randomized to receive placebo (PL), recombinant human growth hormone (r-hGH) at a dose of 4 mg daily (DD) or 4 mg on alternate days (AD) for 12 weeks. For weeks 12 to 24, DD patients were rerandomized to PL (DD-PL) or AD (DD-AD), AD patients continued on AD (AD-AD), and PL patients were switched to DD (PL-DD). RESULTSFrom baseline to week 12, VAT decreased significantly compared with PL in DD (−8.6%, P &lt; 0.001) but not in AD (−4.2%, P = 0.052). Trunk-to-limb fat ratio decreased significantly in both (P &lt; 0.001) compared with PL, as did total cholesterol and non–high-density lipoprotein (HDL) cholesterol (−4.5% and −7.5% in DD, −4.3% and −6.2% in AD). At week 24, all groups displayed significant (P &lt; 0.05) reductions in VAT (−5.3% to −9.5%) and trunk fat (−7.8% to −22.8%). DD-AD and AD-AD also displayed significant (P &lt; 0.05) reductions in non-HDL cholesterol. CONCLUSIONSThese results suggest that r-hGH dosed at 4 mg daily for 12 weeks decreases VAT and cholesterol concentrations in HIV-infected patients with excess VAT. The optimal regimen to sustain these effects awaits determination.</description><subject>Adipose Tissue - anatomy &amp; histology</subject><subject>Adipose Tissue - drug effects</subject><subject>Adolescent</subject><subject>Adult</subject><subject>AIDS/HIV</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Body fat</subject><subject>Cholesterol - blood</subject><subject>Continental Population Groups</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>HIV</subject><subject>HIV Infections - blood</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - physiopathology</subject><subject>Hormones</subject><subject>Human Growth Hormone - administration &amp; dosage</subject><subject>Human Growth Hormone - therapeutic use</subject><subject>Human immunodeficiency virus</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Hyperlipidemias - drug therapy</subject><subject>Infectious diseases</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Microbiology</subject><subject>Middle Aged</subject><subject>Miscellaneous</subject><subject>Placebos</subject><subject>Reproducibility of Results</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><subject>Virology</subject><subject>Viscera</subject><issn>1525-4135</issn><issn>1944-7884</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkl9rFDEUxYNYbLv6FSQI-jaavzOZx6Wt3YWCfah9DZnMHTY1k6zJDEu_vVl3q1KQ5iU38Dv3cu4JQpiSz5S0zRdCKKs5FxUjRBBOKKlIOeIVOqOtEFWjlHhdaslkJSiXp-g854eiqoVo36BTKklTM67O0HQ1DGCnjOOAr1PcTRu8immMAXAMeNmF8jAe37tsIZVi2bttzIDvXM4z4KW18zh7M7lCm9Djy8fs3db1MDqDXcCr9X21DvsR0OPbwkGY8lt0Mhif4d3xXqDvX6_uLlbVzbfr9cXyprKyJsUch15CVzetYqITajCtBdkxXlyAIA2jUgkqpOVlJ4ZbzpnpbcdVK8jQM84X6NOh7zbFnzPkSY97H96bAHHOuqGKcSLrF0HatFwJ0RTwwzPwIc4pFBO6zKu5YCWOBVIHyKaYc4JBb5MbTXrUlOh9fvopP_0nP_07vyJ9f-w_dyP0f4XHwArw8QiYbI0fkgnW5X84qcpiWOHEgdtFP0HKP_y8g6Q3YPy00f_7P_wXLaSwZg</recordid><startdate>20040301</startdate><enddate>20040301</enddate><creator>Kotler, Donald P</creator><creator>Muurahainen, Norma</creator><creator>Grunfeld, Carl</creator><creator>Wanke, Christine</creator><creator>Thompson, Melanie</creator><creator>Saag, Michael</creator><creator>Bock, Daena</creator><creator>Simons, Gregg</creator><creator>Gertner, Joseph M</creator><general>Lippincott Williams &amp; Wilkins, Inc</general><general>Lippincott Williams &amp; Wilkins</general><general>Lippincott Williams &amp; Wilkins Ovid Technologies</general><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>7T2</scope><scope>7T5</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>20040301</creationdate><title>Effects of Growth Hormone on Abnormal Visceral Adipose Tissue Accumulation and Dyslipidemia in HIV-Infected Patients</title><author>Kotler, Donald P ; Muurahainen, Norma ; Grunfeld, Carl ; Wanke, Christine ; Thompson, Melanie ; Saag, Michael ; Bock, Daena ; Simons, Gregg ; Gertner, Joseph M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5604-23ed5eb679824b48fa9ce5b23644e40721584145c3097a3c332adcb38940fd233</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2004</creationdate><topic>Adipose Tissue - anatomy &amp; histology</topic><topic>Adipose Tissue - drug effects</topic><topic>Adolescent</topic><topic>Adult</topic><topic>AIDS/HIV</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Body fat</topic><topic>Cholesterol - blood</topic><topic>Continental Population Groups</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Drug therapy</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>HIV</topic><topic>HIV Infections - blood</topic><topic>HIV Infections - drug therapy</topic><topic>HIV Infections - physiopathology</topic><topic>Hormones</topic><topic>Human Growth Hormone - administration &amp; dosage</topic><topic>Human Growth Hormone - therapeutic use</topic><topic>Human immunodeficiency virus</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Hyperlipidemias - drug therapy</topic><topic>Infectious diseases</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Microbiology</topic><topic>Middle Aged</topic><topic>Miscellaneous</topic><topic>Placebos</topic><topic>Reproducibility of Results</topic><topic>Viral diseases</topic><topic>Viral diseases of the lymphoid tissue and the blood. Aids</topic><topic>Virology</topic><topic>Viscera</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kotler, Donald P</creatorcontrib><creatorcontrib>Muurahainen, Norma</creatorcontrib><creatorcontrib>Grunfeld, Carl</creatorcontrib><creatorcontrib>Wanke, Christine</creatorcontrib><creatorcontrib>Thompson, Melanie</creatorcontrib><creatorcontrib>Saag, Michael</creatorcontrib><creatorcontrib>Bock, Daena</creatorcontrib><creatorcontrib>Simons, Gregg</creatorcontrib><creatorcontrib>Gertner, Joseph M</creatorcontrib><creatorcontrib>Serostim in Adipose Redistribution Syndrome Study Group</creatorcontrib><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>Health and Safety Science Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of acquired immune deficiency syndromes (1999)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kotler, Donald P</au><au>Muurahainen, Norma</au><au>Grunfeld, Carl</au><au>Wanke, Christine</au><au>Thompson, Melanie</au><au>Saag, Michael</au><au>Bock, Daena</au><au>Simons, Gregg</au><au>Gertner, Joseph M</au><aucorp>Serostim in Adipose Redistribution Syndrome Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of Growth Hormone on Abnormal Visceral Adipose Tissue Accumulation and Dyslipidemia in HIV-Infected Patients</atitle><jtitle>Journal of acquired immune deficiency syndromes (1999)</jtitle><addtitle>J Acquir Immune Defic Syndr</addtitle><date>2004-03-01</date><risdate>2004</risdate><volume>35</volume><issue>3</issue><spage>239</spage><epage>252</epage><pages>239-252</pages><issn>1525-4135</issn><eissn>1944-7884</eissn><coden>JDSRET</coden><abstract>BACKGROUNDSome HIV-infected patients develop fat maldistribution with visceral adipose tissue (VAT) accumulation and metabolic abnormalities. No medical treatment is approved by the US Food and Drug Administration to reduce VAT. METHODSIn this double-blind trial, 245 HIV-infected patients with excess VAT were randomized to receive placebo (PL), recombinant human growth hormone (r-hGH) at a dose of 4 mg daily (DD) or 4 mg on alternate days (AD) for 12 weeks. For weeks 12 to 24, DD patients were rerandomized to PL (DD-PL) or AD (DD-AD), AD patients continued on AD (AD-AD), and PL patients were switched to DD (PL-DD). RESULTSFrom baseline to week 12, VAT decreased significantly compared with PL in DD (−8.6%, P &lt; 0.001) but not in AD (−4.2%, P = 0.052). Trunk-to-limb fat ratio decreased significantly in both (P &lt; 0.001) compared with PL, as did total cholesterol and non–high-density lipoprotein (HDL) cholesterol (−4.5% and −7.5% in DD, −4.3% and −6.2% in AD). At week 24, all groups displayed significant (P &lt; 0.05) reductions in VAT (−5.3% to −9.5%) and trunk fat (−7.8% to −22.8%). DD-AD and AD-AD also displayed significant (P &lt; 0.05) reductions in non-HDL cholesterol. CONCLUSIONSThese results suggest that r-hGH dosed at 4 mg daily for 12 weeks decreases VAT and cholesterol concentrations in HIV-infected patients with excess VAT. The optimal regimen to sustain these effects awaits determination.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams &amp; Wilkins, Inc</pub><pmid>15076238</pmid><doi>10.1097/00126334-200403010-00004</doi><tpages>14</tpages><oa>free_for_read</oa></addata></record>
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subjects Adipose Tissue - anatomy & histology
Adipose Tissue - drug effects
Adolescent
Adult
AIDS/HIV
Anti-HIV Agents - therapeutic use
Biological and medical sciences
Body fat
Cholesterol - blood
Continental Population Groups
Double-Blind Method
Drug Administration Schedule
Drug therapy
Female
Fundamental and applied biological sciences. Psychology
HIV
HIV Infections - blood
HIV Infections - drug therapy
HIV Infections - physiopathology
Hormones
Human Growth Hormone - administration & dosage
Human Growth Hormone - therapeutic use
Human immunodeficiency virus
Human viral diseases
Humans
Hyperlipidemias - drug therapy
Infectious diseases
Male
Medical sciences
Microbiology
Middle Aged
Miscellaneous
Placebos
Reproducibility of Results
Viral diseases
Viral diseases of the lymphoid tissue and the blood. Aids
Virology
Viscera
title Effects of Growth Hormone on Abnormal Visceral Adipose Tissue Accumulation and Dyslipidemia in HIV-Infected Patients
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