Short-term ezetimibe is well tolerated and effective in combination with statin therapy to treat elevated LDL cholesterol in HIV-infected patients
Ezetimibe inhibits intestinal absorption of cholesterol. Multicentered double-blind, randomized, placebo-controlled, crossover study to determine the short-term safety, efficacy, and tolerability of ezetimibe in combination with ongoing statin therapy in HIV-infected adults with elevated low-density...
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| Veröffentlicht in: | AIDS (London) 2009-10, Vol.23 (16), p.2133-2141 |
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| creator | Chow, Dominic Chen, Huichao Glesby, Marshall J Busti, Anthony Souza, Scott Andersen, Janet Kohrs, Sharon Wu, Julia Koletar, Susan L |
| description | Ezetimibe inhibits intestinal absorption of cholesterol.
Multicentered double-blind, randomized, placebo-controlled, crossover study to determine the short-term safety, efficacy, and tolerability of ezetimibe in combination with ongoing statin therapy in HIV-infected adults with elevated low-density lipoprotein cholesterol (LDL-C). Participants on stable HAART with fasting LDL-C at least 130 mg/dl and stable statin were randomized to ezetimibe 10 mg daily or placebo for 12 weeks followed by 4 weeks of washout and then 12 weeks with alternative study assignment. Percentage and absolute change in LDL-C (primary endpoint), total cholesterol, triglyceride, high-density lipoprotein cholesterol (HDL-C), apolipoprotein B, and high sensitivity C-reactive protein were compared. Changes in clinical symptoms and safety laboratory measurements were assessed.
Forty-four participants enrolled: 70% men, median age 49 years, 43% White/Non-Hispanic, median CD4 cell count 547 cells/microl, and 95% HIV RNA less than 50 copies/ml. Median (interquartile range) percentage change in LDL-C was -20.8% (-25.4, -10.7) with ezetimibe and -0.7% (-10.3,18.6) with placebo; the median within-participant effect of ezetimibe was -14.1% (-33.0, -5.0; P < 0.0001). Median difference in absolute LDL-C values between ezetimibe and placebo was -32 mg/dl (-58, -6, P < 0.0001). Significant differences in within-participant effect of ezetimibe were noted for total cholesterol -18.60% (-27.22, -11.67, P < 0.001), non-HDL-C -23.18% (-33.14, -14.36, P < 0.0001), and apolipoprotein B -8.73% (-18.75, 1.99, P = 0.02). No significant changes seen in HDL-C, triglyceride, or high sensitivity C-reactive protein. Ezetimibe was well tolerated. Adverse events were similar between phases.
The present short-term study found adding ezetimibe to ongoing statin therapy was well tolerated and effective in reducing LDL-C, total cholesterol, non-HDL-C, and apolipoprotein B. Adding ezetimibe to statin therapy offers reasonable treatment option for HIV-infected patients with elevated LDL-C. |
| doi_str_mv | 10.1097/QAD.0b013e32833068e3 |
| format | Article |
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Multicentered double-blind, randomized, placebo-controlled, crossover study to determine the short-term safety, efficacy, and tolerability of ezetimibe in combination with ongoing statin therapy in HIV-infected adults with elevated low-density lipoprotein cholesterol (LDL-C). Participants on stable HAART with fasting LDL-C at least 130 mg/dl and stable statin were randomized to ezetimibe 10 mg daily or placebo for 12 weeks followed by 4 weeks of washout and then 12 weeks with alternative study assignment. Percentage and absolute change in LDL-C (primary endpoint), total cholesterol, triglyceride, high-density lipoprotein cholesterol (HDL-C), apolipoprotein B, and high sensitivity C-reactive protein were compared. Changes in clinical symptoms and safety laboratory measurements were assessed.
Forty-four participants enrolled: 70% men, median age 49 years, 43% White/Non-Hispanic, median CD4 cell count 547 cells/microl, and 95% HIV RNA less than 50 copies/ml. Median (interquartile range) percentage change in LDL-C was -20.8% (-25.4, -10.7) with ezetimibe and -0.7% (-10.3,18.6) with placebo; the median within-participant effect of ezetimibe was -14.1% (-33.0, -5.0; P < 0.0001). Median difference in absolute LDL-C values between ezetimibe and placebo was -32 mg/dl (-58, -6, P < 0.0001). Significant differences in within-participant effect of ezetimibe were noted for total cholesterol -18.60% (-27.22, -11.67, P < 0.001), non-HDL-C -23.18% (-33.14, -14.36, P < 0.0001), and apolipoprotein B -8.73% (-18.75, 1.99, P = 0.02). No significant changes seen in HDL-C, triglyceride, or high sensitivity C-reactive protein. Ezetimibe was well tolerated. Adverse events were similar between phases.
The present short-term study found adding ezetimibe to ongoing statin therapy was well tolerated and effective in reducing LDL-C, total cholesterol, non-HDL-C, and apolipoprotein B. Adding ezetimibe to statin therapy offers reasonable treatment option for HIV-infected patients with elevated LDL-C.</description><identifier>ISSN: 0269-9370</identifier><identifier>EISSN: 1473-5571</identifier><identifier>DOI: 10.1097/QAD.0b013e32833068e3</identifier><identifier>PMID: 19770624</identifier><language>eng</language><publisher>England</publisher><subject>Absorption ; Acquired immune deficiency syndrome ; Age ; Anticholesteremic Agents - administration & dosage ; Anticholesteremic Agents - adverse effects ; Antiretroviral Therapy, Highly Active ; Apolipoprotein B ; Azetidines - administration & dosage ; Azetidines - adverse effects ; C-reactive protein ; CD4 antigen ; CD4 Lymphocyte Count ; Cholesterol ; Cholesterol, LDL - blood ; Clinical trials ; Cross-Over Studies ; Double-Blind Method ; Drug Administration Schedule ; Drug Therapy, Combination - methods ; Ezetimibe ; Fasting ; Female ; highly active antiretroviral therapy ; HIV Infections - blood ; Human immunodeficiency virus ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage ; Hypercholesterolemia - blood ; Hypercholesterolemia - drug therapy ; Intestinal absorption ; Lipoproteins ; Lipoproteins (low density) ; Male ; Middle Aged ; Proteins ; RNA ; Sensitivity ; Side effects ; statins ; Triglycerides</subject><ispartof>AIDS (London), 2009-10, Vol.23 (16), p.2133-2141</ispartof><rights>2009 Wolters Kluwer Health | Lippincott Williams & Wilkins 2009</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c489t-2506f1871938b8c7a69ad5a2fa49b773180eef6d4a9c3d2810b0c4a796e1a3f83</citedby><cites>FETCH-LOGICAL-c489t-2506f1871938b8c7a69ad5a2fa49b773180eef6d4a9c3d2810b0c4a796e1a3f83</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/19770624$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chow, Dominic</creatorcontrib><creatorcontrib>Chen, Huichao</creatorcontrib><creatorcontrib>Glesby, Marshall J</creatorcontrib><creatorcontrib>Busti, Anthony</creatorcontrib><creatorcontrib>Souza, Scott</creatorcontrib><creatorcontrib>Andersen, Janet</creatorcontrib><creatorcontrib>Kohrs, Sharon</creatorcontrib><creatorcontrib>Wu, Julia</creatorcontrib><creatorcontrib>Koletar, Susan L</creatorcontrib><title>Short-term ezetimibe is well tolerated and effective in combination with statin therapy to treat elevated LDL cholesterol in HIV-infected patients</title><title>AIDS (London)</title><addtitle>AIDS</addtitle><description>Ezetimibe inhibits intestinal absorption of cholesterol.
Multicentered double-blind, randomized, placebo-controlled, crossover study to determine the short-term safety, efficacy, and tolerability of ezetimibe in combination with ongoing statin therapy in HIV-infected adults with elevated low-density lipoprotein cholesterol (LDL-C). Participants on stable HAART with fasting LDL-C at least 130 mg/dl and stable statin were randomized to ezetimibe 10 mg daily or placebo for 12 weeks followed by 4 weeks of washout and then 12 weeks with alternative study assignment. Percentage and absolute change in LDL-C (primary endpoint), total cholesterol, triglyceride, high-density lipoprotein cholesterol (HDL-C), apolipoprotein B, and high sensitivity C-reactive protein were compared. Changes in clinical symptoms and safety laboratory measurements were assessed.
Forty-four participants enrolled: 70% men, median age 49 years, 43% White/Non-Hispanic, median CD4 cell count 547 cells/microl, and 95% HIV RNA less than 50 copies/ml. Median (interquartile range) percentage change in LDL-C was -20.8% (-25.4, -10.7) with ezetimibe and -0.7% (-10.3,18.6) with placebo; the median within-participant effect of ezetimibe was -14.1% (-33.0, -5.0; P < 0.0001). Median difference in absolute LDL-C values between ezetimibe and placebo was -32 mg/dl (-58, -6, P < 0.0001). Significant differences in within-participant effect of ezetimibe were noted for total cholesterol -18.60% (-27.22, -11.67, P < 0.001), non-HDL-C -23.18% (-33.14, -14.36, P < 0.0001), and apolipoprotein B -8.73% (-18.75, 1.99, P = 0.02). No significant changes seen in HDL-C, triglyceride, or high sensitivity C-reactive protein. Ezetimibe was well tolerated. Adverse events were similar between phases.
The present short-term study found adding ezetimibe to ongoing statin therapy was well tolerated and effective in reducing LDL-C, total cholesterol, non-HDL-C, and apolipoprotein B. Adding ezetimibe to statin therapy offers reasonable treatment option for HIV-infected patients with elevated LDL-C.</description><subject>Absorption</subject><subject>Acquired immune deficiency syndrome</subject><subject>Age</subject><subject>Anticholesteremic Agents - administration & dosage</subject><subject>Anticholesteremic Agents - adverse effects</subject><subject>Antiretroviral Therapy, Highly Active</subject><subject>Apolipoprotein B</subject><subject>Azetidines - administration & dosage</subject><subject>Azetidines - adverse effects</subject><subject>C-reactive protein</subject><subject>CD4 antigen</subject><subject>CD4 Lymphocyte Count</subject><subject>Cholesterol</subject><subject>Cholesterol, LDL - blood</subject><subject>Clinical trials</subject><subject>Cross-Over Studies</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Drug Therapy, Combination - methods</subject><subject>Ezetimibe</subject><subject>Fasting</subject><subject>Female</subject><subject>highly active antiretroviral therapy</subject><subject>HIV Infections - blood</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage</subject><subject>Hypercholesterolemia - blood</subject><subject>Hypercholesterolemia - drug therapy</subject><subject>Intestinal absorption</subject><subject>Lipoproteins</subject><subject>Lipoproteins (low density)</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Proteins</subject><subject>RNA</subject><subject>Sensitivity</subject><subject>Side effects</subject><subject>statins</subject><subject>Triglycerides</subject><issn>0269-9370</issn><issn>1473-5571</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkV9rFDEUxYModq1-A5E8-TY1_2aSvAilrbawUKTV15DJ3HEiM8maZLfUj-EnNmsXrT6FcO75neQehF5TckKJlu8-nZ6fkJ5QDpwpzkmngD9BKyokb9pW0qdoRVinG80lOUIvcv5GCGmJUs_REdVSko6JFfp5M8VUmgJpwfADil98D9hnfAfzjEucIdkCA7ZhwDCO4IrfVT1gF5feB1t8DPjOlwnnUi8Bl6k6NvfViksCWzDMsPuNWJ-vsZsqMde0OO8hl1dfGh_21Kpvqh9CyS_Rs9HOGV4dzmP0-cPF7dlls77-eHV2um6cULo0rCXdSJWkmqteOWk7bYfWstEK3UvJqSIAYzcIqx0fmKJ1WU5YqTuglo-KH6P3D9zNtl9gcDU72dlskl9sujfRevOvEvxkvsadYVIxwfeAtwdAit-39Vtm8dnVvdkAcZsNo4wKLrs6KB4GXYo5Jxj_hFBi9mWaWqb5v8xqe_P4gX9Nh_b4L1YVn8M</recordid><startdate>20091023</startdate><enddate>20091023</enddate><creator>Chow, Dominic</creator><creator>Chen, Huichao</creator><creator>Glesby, Marshall J</creator><creator>Busti, Anthony</creator><creator>Souza, Scott</creator><creator>Andersen, Janet</creator><creator>Kohrs, Sharon</creator><creator>Wu, Julia</creator><creator>Koletar, Susan L</creator><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>7U2</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>5PM</scope></search><sort><creationdate>20091023</creationdate><title>Short-term ezetimibe is well tolerated and effective in combination with statin therapy to treat elevated LDL cholesterol in HIV-infected patients</title><author>Chow, Dominic ; Chen, Huichao ; Glesby, Marshall J ; Busti, Anthony ; Souza, Scott ; Andersen, Janet ; Kohrs, Sharon ; Wu, Julia ; Koletar, Susan L</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c489t-2506f1871938b8c7a69ad5a2fa49b773180eef6d4a9c3d2810b0c4a796e1a3f83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Absorption</topic><topic>Acquired immune deficiency syndrome</topic><topic>Age</topic><topic>Anticholesteremic Agents - administration & dosage</topic><topic>Anticholesteremic Agents - adverse effects</topic><topic>Antiretroviral Therapy, Highly Active</topic><topic>Apolipoprotein B</topic><topic>Azetidines - administration & dosage</topic><topic>Azetidines - adverse effects</topic><topic>C-reactive protein</topic><topic>CD4 antigen</topic><topic>CD4 Lymphocyte Count</topic><topic>Cholesterol</topic><topic>Cholesterol, LDL - blood</topic><topic>Clinical trials</topic><topic>Cross-Over Studies</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Drug Therapy, Combination - methods</topic><topic>Ezetimibe</topic><topic>Fasting</topic><topic>Female</topic><topic>highly active antiretroviral therapy</topic><topic>HIV Infections - blood</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage</topic><topic>Hypercholesterolemia - blood</topic><topic>Hypercholesterolemia - drug therapy</topic><topic>Intestinal absorption</topic><topic>Lipoproteins</topic><topic>Lipoproteins (low density)</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Proteins</topic><topic>RNA</topic><topic>Sensitivity</topic><topic>Side effects</topic><topic>statins</topic><topic>Triglycerides</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chow, Dominic</creatorcontrib><creatorcontrib>Chen, Huichao</creatorcontrib><creatorcontrib>Glesby, Marshall J</creatorcontrib><creatorcontrib>Busti, Anthony</creatorcontrib><creatorcontrib>Souza, Scott</creatorcontrib><creatorcontrib>Andersen, Janet</creatorcontrib><creatorcontrib>Kohrs, Sharon</creatorcontrib><creatorcontrib>Wu, Julia</creatorcontrib><creatorcontrib>Koletar, Susan L</creatorcontrib><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>Safety Science and Risk</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>AIDS (London)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chow, Dominic</au><au>Chen, Huichao</au><au>Glesby, Marshall J</au><au>Busti, Anthony</au><au>Souza, Scott</au><au>Andersen, Janet</au><au>Kohrs, Sharon</au><au>Wu, Julia</au><au>Koletar, Susan L</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Short-term ezetimibe is well tolerated and effective in combination with statin therapy to treat elevated LDL cholesterol in HIV-infected patients</atitle><jtitle>AIDS (London)</jtitle><addtitle>AIDS</addtitle><date>2009-10-23</date><risdate>2009</risdate><volume>23</volume><issue>16</issue><spage>2133</spage><epage>2141</epage><pages>2133-2141</pages><issn>0269-9370</issn><eissn>1473-5571</eissn><abstract>Ezetimibe inhibits intestinal absorption of cholesterol.
Multicentered double-blind, randomized, placebo-controlled, crossover study to determine the short-term safety, efficacy, and tolerability of ezetimibe in combination with ongoing statin therapy in HIV-infected adults with elevated low-density lipoprotein cholesterol (LDL-C). Participants on stable HAART with fasting LDL-C at least 130 mg/dl and stable statin were randomized to ezetimibe 10 mg daily or placebo for 12 weeks followed by 4 weeks of washout and then 12 weeks with alternative study assignment. Percentage and absolute change in LDL-C (primary endpoint), total cholesterol, triglyceride, high-density lipoprotein cholesterol (HDL-C), apolipoprotein B, and high sensitivity C-reactive protein were compared. Changes in clinical symptoms and safety laboratory measurements were assessed.
Forty-four participants enrolled: 70% men, median age 49 years, 43% White/Non-Hispanic, median CD4 cell count 547 cells/microl, and 95% HIV RNA less than 50 copies/ml. Median (interquartile range) percentage change in LDL-C was -20.8% (-25.4, -10.7) with ezetimibe and -0.7% (-10.3,18.6) with placebo; the median within-participant effect of ezetimibe was -14.1% (-33.0, -5.0; P < 0.0001). Median difference in absolute LDL-C values between ezetimibe and placebo was -32 mg/dl (-58, -6, P < 0.0001). Significant differences in within-participant effect of ezetimibe were noted for total cholesterol -18.60% (-27.22, -11.67, P < 0.001), non-HDL-C -23.18% (-33.14, -14.36, P < 0.0001), and apolipoprotein B -8.73% (-18.75, 1.99, P = 0.02). No significant changes seen in HDL-C, triglyceride, or high sensitivity C-reactive protein. Ezetimibe was well tolerated. Adverse events were similar between phases.
The present short-term study found adding ezetimibe to ongoing statin therapy was well tolerated and effective in reducing LDL-C, total cholesterol, non-HDL-C, and apolipoprotein B. Adding ezetimibe to statin therapy offers reasonable treatment option for HIV-infected patients with elevated LDL-C.</abstract><cop>England</cop><pmid>19770624</pmid><doi>10.1097/QAD.0b013e32833068e3</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | AIDS (London), 2009-10, Vol.23 (16), p.2133-2141 |
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| source | MEDLINE; Journals@Ovid Complete; EZB-FREE-00999 freely available EZB journals |
| subjects | Absorption Acquired immune deficiency syndrome Age Anticholesteremic Agents - administration & dosage Anticholesteremic Agents - adverse effects Antiretroviral Therapy, Highly Active Apolipoprotein B Azetidines - administration & dosage Azetidines - adverse effects C-reactive protein CD4 antigen CD4 Lymphocyte Count Cholesterol Cholesterol, LDL - blood Clinical trials Cross-Over Studies Double-Blind Method Drug Administration Schedule Drug Therapy, Combination - methods Ezetimibe Fasting Female highly active antiretroviral therapy HIV Infections - blood Human immunodeficiency virus Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage Hypercholesterolemia - blood Hypercholesterolemia - drug therapy Intestinal absorption Lipoproteins Lipoproteins (low density) Male Middle Aged Proteins RNA Sensitivity Side effects statins Triglycerides |
| title | Short-term ezetimibe is well tolerated and effective in combination with statin therapy to treat elevated LDL cholesterol in HIV-infected patients |
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