Safety and Efficacy of Atorvastatin in Human Immunodeficiency Virus-infected Children, Adolescents and Young Adults With Hyperlipidemia

BACKGROUND:Human immunodeficiency virus (HIV)-infected children receiving antiretroviral therapy (ART) have increased prevalence of hyperlipidemia and risk factors for cardiovascular disease. No studies have investigated the efficacy and safety of statins in this population. METHODS:HIV-infected you...

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Veröffentlicht in:The Pediatric infectious disease journal 2017-01, Vol.36 (1), p.53-60
Hauptverfasser: Melvin, Ann J, Montepiedra, Grace, Aaron, Lisa, Meyer, William A, Spiegel, Hans M, Borkowsky, William, Abzug, Mark J, Best, Brookie M, Crain, Marilyn J, Borum, Peggy R, Graham, Bobbie, Anthony, Patricia, Shin, Katherine, Siberry, George K
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container_issue 1
container_start_page 53
container_title The Pediatric infectious disease journal
container_volume 36
creator Melvin, Ann J
Montepiedra, Grace
Aaron, Lisa
Meyer, William A
Spiegel, Hans M
Borkowsky, William
Abzug, Mark J
Best, Brookie M
Crain, Marilyn J
Borum, Peggy R
Graham, Bobbie
Anthony, Patricia
Shin, Katherine
Siberry, George K
description BACKGROUND:Human immunodeficiency virus (HIV)-infected children receiving antiretroviral therapy (ART) have increased prevalence of hyperlipidemia and risk factors for cardiovascular disease. No studies have investigated the efficacy and safety of statins in this population. METHODS:HIV-infected youth 10 to
doi_str_mv 10.1097/INF.0000000000001352
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No studies have investigated the efficacy and safety of statins in this population. METHODS:HIV-infected youth 10 to &lt;24 years of age on stable ART with low-density lipoprotein cholesterol (LDL-C) ≥130 mg/dL for ≥6 months initiated atorvastatin 10 mg once daily. Atorvastatin was increased to 20 mg if LDL-C efficacy criteria (LDL-C &lt; 110 mg/dL or decreased ≥30% from baseline) were not met at week 4. Primary outcomes were safety and efficacy. RESULTS:Twenty-eight youth initiated atorvastatin; 7 were 10–15 years and 21 were 15–24 years. Mean baseline LDL-C was 161 mg/dL (standard deviation 19 mg/dL). Efficacy criteria were met at week 4 by 17 of 27 (63%) participants. Atorvastatin was increased to 20 mg in 10 participants. Mean LDL-C decreased from baseline by 30% (90% confidence interval26%, 35%) at week 4, 28% (90% confidence interval23%, 33%) at week 24 and 26% (90% confidence interval20%, 33%) at week 48. LDL-C was less than 110 mg/dL in 44% at week 4, 42% at week 12 and 46% at weeks 24 and 48. Total cholesterol, non high-density lipoprotein (non-HDL)-C and apolipoprotein B decreased significantly, but IL-6 and high-sensitivity C-reactive protein did not. Two participants in the younger age group discontinued study for toxicities possibly related to atorvastatin. CONCLUSIONS:Atorvastatin lowered total cholesterol, LDL-C, non HDL-C and apolipoprotein B in HIV-infected youth with ART-associated hyperlipidemia. Atorvastatin could be considered for HIV-infected children with hyperlipidemia, but safety monitoring is important particularly in younger children.</description><identifier>ISSN: 0891-3668</identifier><identifier>EISSN: 1532-0987</identifier><identifier>DOI: 10.1097/INF.0000000000001352</identifier><identifier>PMID: 27749649</identifier><language>eng</language><publisher>United States: Copyright Wolters Kluwer Health, Inc. All rights reserved</publisher><subject>Adolescent ; Adult ; Anti-HIV Agents - adverse effects ; Anti-HIV Agents - therapeutic use ; Atorvastatin Calcium - adverse effects ; Atorvastatin Calcium - therapeutic use ; C-Reactive Protein - analysis ; Child ; Female ; HIV Infections - complications ; HIV Infections - drug therapy ; Humans ; Hyperlipidemias - complications ; Male ; Young Adult</subject><ispartof>The Pediatric infectious disease journal, 2017-01, Vol.36 (1), p.53-60</ispartof><rights>Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4572-e726e091755daecd4ee42fdfd4ef45e09891e5ad149ded16ba61c0b7969ff99b3</citedby><cites>FETCH-LOGICAL-c4572-e726e091755daecd4ee42fdfd4ef45e09891e5ad149ded16ba61c0b7969ff99b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27749649$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Melvin, Ann J</creatorcontrib><creatorcontrib>Montepiedra, Grace</creatorcontrib><creatorcontrib>Aaron, Lisa</creatorcontrib><creatorcontrib>Meyer, William A</creatorcontrib><creatorcontrib>Spiegel, Hans M</creatorcontrib><creatorcontrib>Borkowsky, William</creatorcontrib><creatorcontrib>Abzug, Mark J</creatorcontrib><creatorcontrib>Best, Brookie M</creatorcontrib><creatorcontrib>Crain, Marilyn J</creatorcontrib><creatorcontrib>Borum, Peggy R</creatorcontrib><creatorcontrib>Graham, Bobbie</creatorcontrib><creatorcontrib>Anthony, Patricia</creatorcontrib><creatorcontrib>Shin, Katherine</creatorcontrib><creatorcontrib>Siberry, George K</creatorcontrib><creatorcontrib>P1063 Study Team</creatorcontrib><title>Safety and Efficacy of Atorvastatin in Human Immunodeficiency Virus-infected Children, Adolescents and Young Adults With Hyperlipidemia</title><title>The Pediatric infectious disease journal</title><addtitle>Pediatr Infect Dis J</addtitle><description>BACKGROUND:Human immunodeficiency virus (HIV)-infected children receiving antiretroviral therapy (ART) have increased prevalence of hyperlipidemia and risk factors for cardiovascular disease. No studies have investigated the efficacy and safety of statins in this population. METHODS:HIV-infected youth 10 to &lt;24 years of age on stable ART with low-density lipoprotein cholesterol (LDL-C) ≥130 mg/dL for ≥6 months initiated atorvastatin 10 mg once daily. Atorvastatin was increased to 20 mg if LDL-C efficacy criteria (LDL-C &lt; 110 mg/dL or decreased ≥30% from baseline) were not met at week 4. Primary outcomes were safety and efficacy. RESULTS:Twenty-eight youth initiated atorvastatin; 7 were 10–15 years and 21 were 15–24 years. Mean baseline LDL-C was 161 mg/dL (standard deviation 19 mg/dL). Efficacy criteria were met at week 4 by 17 of 27 (63%) participants. Atorvastatin was increased to 20 mg in 10 participants. Mean LDL-C decreased from baseline by 30% (90% confidence interval26%, 35%) at week 4, 28% (90% confidence interval23%, 33%) at week 24 and 26% (90% confidence interval20%, 33%) at week 48. LDL-C was less than 110 mg/dL in 44% at week 4, 42% at week 12 and 46% at weeks 24 and 48. Total cholesterol, non high-density lipoprotein (non-HDL)-C and apolipoprotein B decreased significantly, but IL-6 and high-sensitivity C-reactive protein did not. Two participants in the younger age group discontinued study for toxicities possibly related to atorvastatin. CONCLUSIONS:Atorvastatin lowered total cholesterol, LDL-C, non HDL-C and apolipoprotein B in HIV-infected youth with ART-associated hyperlipidemia. Atorvastatin could be considered for HIV-infected children with hyperlipidemia, but safety monitoring is important particularly in younger children.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Anti-HIV Agents - adverse effects</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Atorvastatin Calcium - adverse effects</subject><subject>Atorvastatin Calcium - therapeutic use</subject><subject>C-Reactive Protein - analysis</subject><subject>Child</subject><subject>Female</subject><subject>HIV Infections - complications</subject><subject>HIV Infections - drug therapy</subject><subject>Humans</subject><subject>Hyperlipidemias - complications</subject><subject>Male</subject><subject>Young Adult</subject><issn>0891-3668</issn><issn>1532-0987</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kd9qHCEUxiW0NNu0bxCKD9BJdUZn1pvAsmyyC6G96D9yJe54zNg6uqiTsE_Q167ppiHNRUXwcM7v-1Q-hE4pOaNEdB82Hy_OyJNFG14foRnlTV0RMe9eoBmZC1o1bTs_Rq9T-lGghlHyCh3XXcdEy8QM_fqsDOQ9Vl7jlTG2V_0eB4MXOcRblbLK1uOy19OoPN6M4-SDhsJZ8IX8ZuOUKusN9Bk0Xg7W6Qj-PV7o4CD14HP6430dJn9TupMrje82D3i930F0dmc1jFa9QS-NcgnePpwn6OvF6styXV19utwsF1dVz3hXV9DVLRBBO861gl4zAFYbbUphGC-T8mPgSlMmNGjablVLe7LtRCuMEWLbnKDzg-9u2o6g7x8YlZO7aEcV9zIoK_-deDvIm3ArOeVMNLQYsINBH0NKEcyjlhJ5H4wswcjnwRTZu6f3Por-JlGA-QG4Cy5DTD_ddAdRDqBcHv7v_RseaZ7g</recordid><startdate>201701</startdate><enddate>201701</enddate><creator>Melvin, Ann J</creator><creator>Montepiedra, Grace</creator><creator>Aaron, Lisa</creator><creator>Meyer, William A</creator><creator>Spiegel, Hans M</creator><creator>Borkowsky, William</creator><creator>Abzug, Mark J</creator><creator>Best, Brookie M</creator><creator>Crain, Marilyn J</creator><creator>Borum, Peggy R</creator><creator>Graham, Bobbie</creator><creator>Anthony, Patricia</creator><creator>Shin, Katherine</creator><creator>Siberry, George K</creator><general>Copyright Wolters Kluwer Health, Inc. 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No studies have investigated the efficacy and safety of statins in this population. METHODS:HIV-infected youth 10 to &lt;24 years of age on stable ART with low-density lipoprotein cholesterol (LDL-C) ≥130 mg/dL for ≥6 months initiated atorvastatin 10 mg once daily. Atorvastatin was increased to 20 mg if LDL-C efficacy criteria (LDL-C &lt; 110 mg/dL or decreased ≥30% from baseline) were not met at week 4. Primary outcomes were safety and efficacy. RESULTS:Twenty-eight youth initiated atorvastatin; 7 were 10–15 years and 21 were 15–24 years. Mean baseline LDL-C was 161 mg/dL (standard deviation 19 mg/dL). Efficacy criteria were met at week 4 by 17 of 27 (63%) participants. Atorvastatin was increased to 20 mg in 10 participants. Mean LDL-C decreased from baseline by 30% (90% confidence interval26%, 35%) at week 4, 28% (90% confidence interval23%, 33%) at week 24 and 26% (90% confidence interval20%, 33%) at week 48. LDL-C was less than 110 mg/dL in 44% at week 4, 42% at week 12 and 46% at weeks 24 and 48. Total cholesterol, non high-density lipoprotein (non-HDL)-C and apolipoprotein B decreased significantly, but IL-6 and high-sensitivity C-reactive protein did not. Two participants in the younger age group discontinued study for toxicities possibly related to atorvastatin. CONCLUSIONS:Atorvastatin lowered total cholesterol, LDL-C, non HDL-C and apolipoprotein B in HIV-infected youth with ART-associated hyperlipidemia. Atorvastatin could be considered for HIV-infected children with hyperlipidemia, but safety monitoring is important particularly in younger children.</abstract><cop>United States</cop><pub>Copyright Wolters Kluwer Health, Inc. All rights reserved</pub><pmid>27749649</pmid><doi>10.1097/INF.0000000000001352</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record>
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identifier ISSN: 0891-3668
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subjects Adolescent
Adult
Anti-HIV Agents - adverse effects
Anti-HIV Agents - therapeutic use
Atorvastatin Calcium - adverse effects
Atorvastatin Calcium - therapeutic use
C-Reactive Protein - analysis
Child
Female
HIV Infections - complications
HIV Infections - drug therapy
Humans
Hyperlipidemias - complications
Male
Young Adult
title Safety and Efficacy of Atorvastatin in Human Immunodeficiency Virus-infected Children, Adolescents and Young Adults With Hyperlipidemia
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