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Efficacy and Safety of the PCSK9 Inhibitor Evolocumab in Patients with Mixed Hyperlipidemia
Purpose Evolocumab significantly reduces low-density lipoprotein-cholesterol (LDL-C); we investigated its effects on LDL-C lowering in patients with mixed hyperlipidemia. Methods We compared the efficacy and safety of evolocumab in hypercholesterolemic patients selected from the phase 2 and 3 trials...
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| Published in: | Cardiovascular drugs and therapy 2016-06, Vol.30 (3), p.305-313 |
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| container_issue | 3 |
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| container_title | Cardiovascular drugs and therapy |
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| creator | Rosenson, Robert S. Jacobson, Terry A. Preiss, David Djedjos, C. Stephen Dent, Ricardo Bridges, Ian Miller, Michael |
| description | Purpose
Evolocumab significantly reduces low-density lipoprotein-cholesterol (LDL-C); we investigated its effects on LDL-C lowering in patients with mixed hyperlipidemia.
Methods
We compared the efficacy and safety of evolocumab in hypercholesterolemic patients selected from the phase 2 and 3 trials who had fasting triglyceride levels ≥1.7 mmol/L (150 mg/dL elevated triglycerides) and |
| doi_str_mv | 10.1007/s10557-016-6666-1 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4919379</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1808739781</sourcerecordid><originalsourceid>FETCH-LOGICAL-c503t-b32be5aa6dc09f763b7f2fa908e4773f80037df87d351260ae26b12cd968b5833</originalsourceid><addsrcrecordid>eNqFkU9v1DAQxS0EokvhA3BBlrj0kjK2E_-5IKHVQitaUalw4mA5jt11lcSLnRT22-PtlqogVczFh_nNm-d5CL0mcEwAxLtMoGlEBYRXvFRFnqAFaQSrBK3JU7QARaFiFPgBepHzNZQZpeRzdEALAFywBfq-8j5YY7fYjB2-NN5NWxw9ntYOXywvPyt8Oq5DG6aY8Oom9tHOg2lxGPGFmYIbp4x_hmmNz8Mv1-GT7calPmxC54ZgXqJn3vTZvbp7D9G3j6uvy5Pq7Mun0-WHs8o2wKaqZbR1jTG8s6C84KwVnnqjQLpaCOYlABOdl6JjDaEcjKO8JdR2isu2kYwdovd73c3cDq6zxVUyvd6kMJi01dEE_XdnDGt9FW90rYhiQhWBozuBFH_MLk96CNm6vjeji3PWRIIUTAlJ_o-WCzeNrIUs6Nt_0Os4p7Fc4pYitSrBFYrsKZtizsn5e98E9C5lvU9ZF1jvUtY7E28efvh-4k-sBaB7IJfWeOXSg9WPqv4GSIWxuA</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1799149016</pqid></control><display><type>article</type><title>Efficacy and Safety of the PCSK9 Inhibitor Evolocumab in Patients with Mixed Hyperlipidemia</title><source>Springer Link</source><creator>Rosenson, Robert S. ; Jacobson, Terry A. ; Preiss, David ; Djedjos, C. Stephen ; Dent, Ricardo ; Bridges, Ian ; Miller, Michael</creator><creatorcontrib>Rosenson, Robert S. ; Jacobson, Terry A. ; Preiss, David ; Djedjos, C. Stephen ; Dent, Ricardo ; Bridges, Ian ; Miller, Michael</creatorcontrib><description>Purpose
Evolocumab significantly reduces low-density lipoprotein-cholesterol (LDL-C); we investigated its effects on LDL-C lowering in patients with mixed hyperlipidemia.
Methods
We compared the efficacy and safety of evolocumab in hypercholesterolemic patients selected from the phase 2 and 3 trials who had fasting triglyceride levels ≥1.7 mmol/L (150 mg/dL elevated triglycerides) and <1.7 mmol/L (without elevated triglycerides). Fasting triglyceride level ≥ 4.5 mmol/L at screening was an exclusion criterion for these studies, but post-enrollment triglyceride levels may have exceeded 4.5 mmol/L (400 mg/dL). Efficacy was evaluated in four phase 3 randomized studies (
n
= 1148) and safety from the phase 2 and 3 studies (
n
= 2246) and their open-label extension studies (
n
= 1698). Efficacy analyses were based on 12-week studies, while safety analyses included data from all available studies. Treatment differences were calculated vs. placebo and ezetimibe after pooling dose frequencies.
Results
Mean treatment difference in percentage change from baseline in LDL-C for participants with elevated triglycerides and those without elevated triglycerides (mean of weeks 10 and 12) with evolocumab was approximately −67 % vs. placebo and −42 % vs. ezetimibe (all
P
< 0.001) compared to −6 % vs. placebo and −39 % vs. ezetimibe, respectively. Treatment differences for evolocumab vs. placebo and ezetimibe followed a similar pattern for non–high-density lipoprotein (HDL-C) and apolipoprotein B. Evolocumab was well tolerated, with balanced rates of adverse events leading to discontinuation of evolocumab vs. comparator (placebo and/or ezetimibe).
Conclusion
The significant reductions of atherogenic lipids including LDL-C, non–HDL-C, and apolipoprotein B seen with evolocumab are similar in patients with and without mixed hyperlipidemia.</description><identifier>ISSN: 0920-3206</identifier><identifier>EISSN: 1573-7241</identifier><identifier>DOI: 10.1007/s10557-016-6666-1</identifier><identifier>PMID: 27240673</identifier><identifier>CODEN: CDTHET</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal - adverse effects ; Antibodies, Monoclonal - therapeutic use ; Anticholesteremic Agents - adverse effects ; Anticholesteremic Agents - therapeutic use ; Apolipoproteins B - blood ; Cardiology ; Cholesterol - blood ; Double-Blind Method ; Ezetimibe - adverse effects ; Ezetimibe - therapeutic use ; Female ; Humans ; Hypercholesterolemia - blood ; Hypercholesterolemia - drug therapy ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Original ; Original Article ; Proprotein Convertase 9 - antagonists & inhibitors ; Treatment Outcome ; Triglycerides - blood ; Young Adult</subject><ispartof>Cardiovascular drugs and therapy, 2016-06, Vol.30 (3), p.305-313</ispartof><rights>The Author(s) 2016</rights><rights>Springer Science+Business Media New York 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c503t-b32be5aa6dc09f763b7f2fa908e4773f80037df87d351260ae26b12cd968b5833</citedby><cites>FETCH-LOGICAL-c503t-b32be5aa6dc09f763b7f2fa908e4773f80037df87d351260ae26b12cd968b5833</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27240673$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rosenson, Robert S.</creatorcontrib><creatorcontrib>Jacobson, Terry A.</creatorcontrib><creatorcontrib>Preiss, David</creatorcontrib><creatorcontrib>Djedjos, C. Stephen</creatorcontrib><creatorcontrib>Dent, Ricardo</creatorcontrib><creatorcontrib>Bridges, Ian</creatorcontrib><creatorcontrib>Miller, Michael</creatorcontrib><title>Efficacy and Safety of the PCSK9 Inhibitor Evolocumab in Patients with Mixed Hyperlipidemia</title><title>Cardiovascular drugs and therapy</title><addtitle>Cardiovasc Drugs Ther</addtitle><addtitle>Cardiovasc Drugs Ther</addtitle><description>Purpose
Evolocumab significantly reduces low-density lipoprotein-cholesterol (LDL-C); we investigated its effects on LDL-C lowering in patients with mixed hyperlipidemia.
Methods
We compared the efficacy and safety of evolocumab in hypercholesterolemic patients selected from the phase 2 and 3 trials who had fasting triglyceride levels ≥1.7 mmol/L (150 mg/dL elevated triglycerides) and <1.7 mmol/L (without elevated triglycerides). Fasting triglyceride level ≥ 4.5 mmol/L at screening was an exclusion criterion for these studies, but post-enrollment triglyceride levels may have exceeded 4.5 mmol/L (400 mg/dL). Efficacy was evaluated in four phase 3 randomized studies (
n
= 1148) and safety from the phase 2 and 3 studies (
n
= 2246) and their open-label extension studies (
n
= 1698). Efficacy analyses were based on 12-week studies, while safety analyses included data from all available studies. Treatment differences were calculated vs. placebo and ezetimibe after pooling dose frequencies.
Results
Mean treatment difference in percentage change from baseline in LDL-C for participants with elevated triglycerides and those without elevated triglycerides (mean of weeks 10 and 12) with evolocumab was approximately −67 % vs. placebo and −42 % vs. ezetimibe (all
P
< 0.001) compared to −6 % vs. placebo and −39 % vs. ezetimibe, respectively. Treatment differences for evolocumab vs. placebo and ezetimibe followed a similar pattern for non–high-density lipoprotein (HDL-C) and apolipoprotein B. Evolocumab was well tolerated, with balanced rates of adverse events leading to discontinuation of evolocumab vs. comparator (placebo and/or ezetimibe).
Conclusion
The significant reductions of atherogenic lipids including LDL-C, non–HDL-C, and apolipoprotein B seen with evolocumab are similar in patients with and without mixed hyperlipidemia.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antibodies, Monoclonal - adverse effects</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Anticholesteremic Agents - adverse effects</subject><subject>Anticholesteremic Agents - therapeutic use</subject><subject>Apolipoproteins B - blood</subject><subject>Cardiology</subject><subject>Cholesterol - blood</subject><subject>Double-Blind Method</subject><subject>Ezetimibe - adverse effects</subject><subject>Ezetimibe - therapeutic use</subject><subject>Female</subject><subject>Humans</subject><subject>Hypercholesterolemia - blood</subject><subject>Hypercholesterolemia - drug therapy</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Original</subject><subject>Original Article</subject><subject>Proprotein Convertase 9 - antagonists & inhibitors</subject><subject>Treatment Outcome</subject><subject>Triglycerides - blood</subject><subject>Young Adult</subject><issn>0920-3206</issn><issn>1573-7241</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><recordid>eNqFkU9v1DAQxS0EokvhA3BBlrj0kjK2E_-5IKHVQitaUalw4mA5jt11lcSLnRT22-PtlqogVczFh_nNm-d5CL0mcEwAxLtMoGlEBYRXvFRFnqAFaQSrBK3JU7QARaFiFPgBepHzNZQZpeRzdEALAFywBfq-8j5YY7fYjB2-NN5NWxw9ntYOXywvPyt8Oq5DG6aY8Oom9tHOg2lxGPGFmYIbp4x_hmmNz8Mv1-GT7calPmxC54ZgXqJn3vTZvbp7D9G3j6uvy5Pq7Mun0-WHs8o2wKaqZbR1jTG8s6C84KwVnnqjQLpaCOYlABOdl6JjDaEcjKO8JdR2isu2kYwdovd73c3cDq6zxVUyvd6kMJi01dEE_XdnDGt9FW90rYhiQhWBozuBFH_MLk96CNm6vjeji3PWRIIUTAlJ_o-WCzeNrIUs6Nt_0Os4p7Fc4pYitSrBFYrsKZtizsn5e98E9C5lvU9ZF1jvUtY7E28efvh-4k-sBaB7IJfWeOXSg9WPqv4GSIWxuA</recordid><startdate>20160601</startdate><enddate>20160601</enddate><creator>Rosenson, Robert S.</creator><creator>Jacobson, Terry A.</creator><creator>Preiss, David</creator><creator>Djedjos, C. Stephen</creator><creator>Dent, Ricardo</creator><creator>Bridges, Ian</creator><creator>Miller, Michael</creator><general>Springer US</general><general>Springer Nature B.V</general><scope>C6C</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>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M7Z</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>7QO</scope><scope>5PM</scope></search><sort><creationdate>20160601</creationdate><title>Efficacy and Safety of the PCSK9 Inhibitor Evolocumab in Patients with Mixed Hyperlipidemia</title><author>Rosenson, Robert S. ; Jacobson, Terry A. ; Preiss, David ; Djedjos, C. Stephen ; Dent, Ricardo ; Bridges, Ian ; Miller, Michael</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c503t-b32be5aa6dc09f763b7f2fa908e4773f80037df87d351260ae26b12cd968b5833</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antibodies, Monoclonal - adverse effects</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>Anticholesteremic Agents - adverse effects</topic><topic>Anticholesteremic Agents - therapeutic use</topic><topic>Apolipoproteins B - blood</topic><topic>Cardiology</topic><topic>Cholesterol - blood</topic><topic>Double-Blind Method</topic><topic>Ezetimibe - adverse effects</topic><topic>Ezetimibe - therapeutic use</topic><topic>Female</topic><topic>Humans</topic><topic>Hypercholesterolemia - blood</topic><topic>Hypercholesterolemia - drug therapy</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Original</topic><topic>Original Article</topic><topic>Proprotein Convertase 9 - antagonists & inhibitors</topic><topic>Treatment Outcome</topic><topic>Triglycerides - blood</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rosenson, Robert S.</creatorcontrib><creatorcontrib>Jacobson, Terry A.</creatorcontrib><creatorcontrib>Preiss, David</creatorcontrib><creatorcontrib>Djedjos, C. Stephen</creatorcontrib><creatorcontrib>Dent, Ricardo</creatorcontrib><creatorcontrib>Bridges, Ian</creatorcontrib><creatorcontrib>Miller, Michael</creatorcontrib><collection>SpringerOpen</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>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central</collection><collection>ProQuest Databases</collection><collection>ProQuest One Community College</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>Biochemistry Abstracts 1</collection><collection>Biotechnology and BioEngineering Abstracts</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>MEDLINE - Academic</collection><collection>Biotechnology Research Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Cardiovascular drugs and therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rosenson, Robert S.</au><au>Jacobson, Terry A.</au><au>Preiss, David</au><au>Djedjos, C. Stephen</au><au>Dent, Ricardo</au><au>Bridges, Ian</au><au>Miller, Michael</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and Safety of the PCSK9 Inhibitor Evolocumab in Patients with Mixed Hyperlipidemia</atitle><jtitle>Cardiovascular drugs and therapy</jtitle><stitle>Cardiovasc Drugs Ther</stitle><addtitle>Cardiovasc Drugs Ther</addtitle><date>2016-06-01</date><risdate>2016</risdate><volume>30</volume><issue>3</issue><spage>305</spage><epage>313</epage><pages>305-313</pages><issn>0920-3206</issn><eissn>1573-7241</eissn><coden>CDTHET</coden><abstract>Purpose
Evolocumab significantly reduces low-density lipoprotein-cholesterol (LDL-C); we investigated its effects on LDL-C lowering in patients with mixed hyperlipidemia.
Methods
We compared the efficacy and safety of evolocumab in hypercholesterolemic patients selected from the phase 2 and 3 trials who had fasting triglyceride levels ≥1.7 mmol/L (150 mg/dL elevated triglycerides) and <1.7 mmol/L (without elevated triglycerides). Fasting triglyceride level ≥ 4.5 mmol/L at screening was an exclusion criterion for these studies, but post-enrollment triglyceride levels may have exceeded 4.5 mmol/L (400 mg/dL). Efficacy was evaluated in four phase 3 randomized studies (
n
= 1148) and safety from the phase 2 and 3 studies (
n
= 2246) and their open-label extension studies (
n
= 1698). Efficacy analyses were based on 12-week studies, while safety analyses included data from all available studies. Treatment differences were calculated vs. placebo and ezetimibe after pooling dose frequencies.
Results
Mean treatment difference in percentage change from baseline in LDL-C for participants with elevated triglycerides and those without elevated triglycerides (mean of weeks 10 and 12) with evolocumab was approximately −67 % vs. placebo and −42 % vs. ezetimibe (all
P
< 0.001) compared to −6 % vs. placebo and −39 % vs. ezetimibe, respectively. Treatment differences for evolocumab vs. placebo and ezetimibe followed a similar pattern for non–high-density lipoprotein (HDL-C) and apolipoprotein B. Evolocumab was well tolerated, with balanced rates of adverse events leading to discontinuation of evolocumab vs. comparator (placebo and/or ezetimibe).
Conclusion
The significant reductions of atherogenic lipids including LDL-C, non–HDL-C, and apolipoprotein B seen with evolocumab are similar in patients with and without mixed hyperlipidemia.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>27240673</pmid><doi>10.1007/s10557-016-6666-1</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Cardiovascular drugs and therapy, 2016-06, Vol.30 (3), p.305-313 |
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| subjects | Adolescent Adult Aged Aged, 80 and over Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal - therapeutic use Anticholesteremic Agents - adverse effects Anticholesteremic Agents - therapeutic use Apolipoproteins B - blood Cardiology Cholesterol - blood Double-Blind Method Ezetimibe - adverse effects Ezetimibe - therapeutic use Female Humans Hypercholesterolemia - blood Hypercholesterolemia - drug therapy Male Medicine Medicine & Public Health Middle Aged Original Original Article Proprotein Convertase 9 - antagonists & inhibitors Treatment Outcome Triglycerides - blood Young Adult |
| title | Efficacy and Safety of the PCSK9 Inhibitor Evolocumab in Patients with Mixed Hyperlipidemia |
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