Efficacy and Safety of Pitavastatin in Children and Adolescents at High Future Cardiovascular Risk
Objectives To assess the safety and efficacy of pitavastatin in children and adolescents with hyperlipidemia. Study design A total of 106 children and adolescents with hyperlipidemia, ages 6 to 17 years, were enrolled in a 12-week randomized, double-blind, placebo-controlled study and randomly assig...
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| Veröffentlicht in: | The Journal of pediatrics 2015-08, Vol.167 (2), p.338-343.e5 |
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| creator | Braamskamp, Marjet J.A.M., MD Stefanutti, Claudia, MD, PhD Langslet, Gisle, MD Drogari, Euridiki, MD, PhD Wiegman, Albert, MD, PhD Hounslow, Neil, MRCP, FFPM Kastelein, John J.P., MD, PhD |
| description | Objectives To assess the safety and efficacy of pitavastatin in children and adolescents with hyperlipidemia. Study design A total of 106 children and adolescents with hyperlipidemia, ages 6 to 17 years, were enrolled in a 12-week randomized, double-blind, placebo-controlled study and randomly assigned to pitavastatin 1 mg, 2 mg, 4 mg, or placebo. During a 52-week extension period, subjects were up-titrated from 1 mg pitavastatin to a maximum dose of 4 mg in an effort to achieve an optimum low-density lipoprotein cholesterol (LDL-C) treatment target of |
| doi_str_mv | 10.1016/j.jpeds.2015.05.006 |
| format | Article |
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Study design A total of 106 children and adolescents with hyperlipidemia, ages 6 to 17 years, were enrolled in a 12-week randomized, double-blind, placebo-controlled study and randomly assigned to pitavastatin 1 mg, 2 mg, 4 mg, or placebo. During a 52-week extension period, subjects were up-titrated from 1 mg pitavastatin to a maximum dose of 4 mg in an effort to achieve an optimum low-density lipoprotein cholesterol (LDL-C) treatment target of <110 mg/dL (2.8 mmol/L). Adverse events rates, including abnormal clinical laboratory variables, vital signs, and physical examination were assessed. Results Compared with placebo, pitavastatin 1, 2, and 4 mg significantly reduced LDL-C from baseline by 23.5%, 30.1%, and 39.3%, respectively, and in the open-label study 20.5% of the subjects reached the LDL-C goal <110 mg/dL (2.8 mmol/L). No safety issues were evident. Conclusions Pitavastatin at doses up to 4 mg is well tolerated and efficacious in children and adolescents aged 6-17 years. Trial registration Registered with EudraCT 2011-004964-32 and EudraCT 2011-004983-32.</description><identifier>ISSN: 0022-3476</identifier><identifier>EISSN: 1097-6833</identifier><identifier>DOI: 10.1016/j.jpeds.2015.05.006</identifier><identifier>PMID: 26059337</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adolescent ; Age Factors ; Apolipoproteins - blood ; Cardiovascular Diseases - blood ; Cardiovascular Diseases - etiology ; Child ; Cholesterol - blood ; Dose-Response Relationship, Drug ; Double-Blind Method ; Europe ; Female ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - pharmacokinetics ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use ; Hyperlipidemias - blood ; Hyperlipidemias - drug therapy ; Male ; Pediatrics ; Quinolines - pharmacokinetics ; Quinolines - therapeutic use ; Risk Factors ; Treatment Outcome ; Triglycerides - blood</subject><ispartof>The Journal of pediatrics, 2015-08, Vol.167 (2), p.338-343.e5</ispartof><rights>Elsevier Inc.</rights><rights>2015 Elsevier Inc.</rights><rights>Copyright © 2015 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c550t-ad55b0d254df43f5afa302d08b53edd071ee85bbd1c2a8e4a1dc011c7a2b5db23</citedby><cites>FETCH-LOGICAL-c550t-ad55b0d254df43f5afa302d08b53edd071ee85bbd1c2a8e4a1dc011c7a2b5db23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0022347615004746$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27903,27904,65309</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26059337$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Braamskamp, Marjet J.A.M., MD</creatorcontrib><creatorcontrib>Stefanutti, Claudia, MD, PhD</creatorcontrib><creatorcontrib>Langslet, Gisle, MD</creatorcontrib><creatorcontrib>Drogari, Euridiki, MD, PhD</creatorcontrib><creatorcontrib>Wiegman, Albert, MD, PhD</creatorcontrib><creatorcontrib>Hounslow, Neil, MRCP, FFPM</creatorcontrib><creatorcontrib>Kastelein, John J.P., MD, PhD</creatorcontrib><creatorcontrib>PASCAL Study Group</creatorcontrib><title>Efficacy and Safety of Pitavastatin in Children and Adolescents at High Future Cardiovascular Risk</title><title>The Journal of pediatrics</title><addtitle>J Pediatr</addtitle><description>Objectives To assess the safety and efficacy of pitavastatin in children and adolescents with hyperlipidemia. Study design A total of 106 children and adolescents with hyperlipidemia, ages 6 to 17 years, were enrolled in a 12-week randomized, double-blind, placebo-controlled study and randomly assigned to pitavastatin 1 mg, 2 mg, 4 mg, or placebo. During a 52-week extension period, subjects were up-titrated from 1 mg pitavastatin to a maximum dose of 4 mg in an effort to achieve an optimum low-density lipoprotein cholesterol (LDL-C) treatment target of <110 mg/dL (2.8 mmol/L). Adverse events rates, including abnormal clinical laboratory variables, vital signs, and physical examination were assessed. Results Compared with placebo, pitavastatin 1, 2, and 4 mg significantly reduced LDL-C from baseline by 23.5%, 30.1%, and 39.3%, respectively, and in the open-label study 20.5% of the subjects reached the LDL-C goal <110 mg/dL (2.8 mmol/L). No safety issues were evident. Conclusions Pitavastatin at doses up to 4 mg is well tolerated and efficacious in children and adolescents aged 6-17 years. Trial registration Registered with EudraCT 2011-004964-32 and EudraCT 2011-004983-32.</description><subject>Adolescent</subject><subject>Age Factors</subject><subject>Apolipoproteins - blood</subject><subject>Cardiovascular Diseases - blood</subject><subject>Cardiovascular Diseases - etiology</subject><subject>Child</subject><subject>Cholesterol - blood</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Europe</subject><subject>Female</subject><subject>Humans</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - pharmacokinetics</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use</subject><subject>Hyperlipidemias - blood</subject><subject>Hyperlipidemias - drug therapy</subject><subject>Male</subject><subject>Pediatrics</subject><subject>Quinolines - pharmacokinetics</subject><subject>Quinolines - therapeutic use</subject><subject>Risk Factors</subject><subject>Treatment Outcome</subject><subject>Triglycerides - blood</subject><issn>0022-3476</issn><issn>1097-6833</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkUFr3DAQhUVpabZpfkGh6NiLNyPJkteHFsKSNIFAQ9KchSyNGjleeyvJgf330WbTHnopPJjLe5rR9wj5xGDJgKnTftlv0aUlByaXUATqDVkwaJtKrYR4SxYAnFeibtQR-ZBSDwBtDfCeHHEFshWiWZDu3Ptgjd1RMzp6ZzzmHZ08vQnZPJmUTQ4jLVo_hMFFHF9sZ24aMFkcc6Im08vw64FezHmOSNcmujCVpJ0HE-ltSI8fyTtvhoQnr_OY3F-c_1xfVtc_vl-tz64rKyXkyjgpO3Bc1s7XwkvjjQDuYNVJgc5BwxBXsuscs9yssDbMWWDMNoZ30nVcHJMvh3e3cfo9Y8p6E8qRw2BGnOakmWrbuhWtEsUqDlYbp5Qier2NYWPiTjPQe7i61y9w9R6uhiJQJfX5dcHcbdD9zfyhWQxfDwYs33wKGHWyAUeLLkS0Wbsp_GfBt3_ydghjqWd4xB2mfprjWAhqphPXoO_2_e7rZRKgbmolngE-s6HC</recordid><startdate>20150801</startdate><enddate>20150801</enddate><creator>Braamskamp, Marjet J.A.M., MD</creator><creator>Stefanutti, Claudia, MD, PhD</creator><creator>Langslet, Gisle, MD</creator><creator>Drogari, Euridiki, MD, PhD</creator><creator>Wiegman, Albert, MD, PhD</creator><creator>Hounslow, Neil, MRCP, FFPM</creator><creator>Kastelein, John J.P., MD, PhD</creator><general>Elsevier Inc</general><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>7X8</scope></search><sort><creationdate>20150801</creationdate><title>Efficacy and Safety of Pitavastatin in Children and Adolescents at High Future Cardiovascular Risk</title><author>Braamskamp, Marjet J.A.M., MD ; Stefanutti, Claudia, MD, PhD ; Langslet, Gisle, MD ; Drogari, Euridiki, MD, PhD ; Wiegman, Albert, MD, PhD ; Hounslow, Neil, MRCP, FFPM ; Kastelein, John J.P., MD, PhD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c550t-ad55b0d254df43f5afa302d08b53edd071ee85bbd1c2a8e4a1dc011c7a2b5db23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adolescent</topic><topic>Age Factors</topic><topic>Apolipoproteins - blood</topic><topic>Cardiovascular Diseases - blood</topic><topic>Cardiovascular Diseases - etiology</topic><topic>Child</topic><topic>Cholesterol - blood</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Europe</topic><topic>Female</topic><topic>Humans</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors - pharmacokinetics</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use</topic><topic>Hyperlipidemias - blood</topic><topic>Hyperlipidemias - drug therapy</topic><topic>Male</topic><topic>Pediatrics</topic><topic>Quinolines - pharmacokinetics</topic><topic>Quinolines - therapeutic use</topic><topic>Risk Factors</topic><topic>Treatment Outcome</topic><topic>Triglycerides - blood</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Braamskamp, Marjet J.A.M., MD</creatorcontrib><creatorcontrib>Stefanutti, Claudia, MD, PhD</creatorcontrib><creatorcontrib>Langslet, Gisle, MD</creatorcontrib><creatorcontrib>Drogari, Euridiki, MD, PhD</creatorcontrib><creatorcontrib>Wiegman, Albert, MD, PhD</creatorcontrib><creatorcontrib>Hounslow, Neil, MRCP, FFPM</creatorcontrib><creatorcontrib>Kastelein, John J.P., MD, PhD</creatorcontrib><creatorcontrib>PASCAL Study Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>The Journal of pediatrics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Braamskamp, Marjet J.A.M., MD</au><au>Stefanutti, Claudia, MD, PhD</au><au>Langslet, Gisle, MD</au><au>Drogari, Euridiki, MD, PhD</au><au>Wiegman, Albert, MD, PhD</au><au>Hounslow, Neil, MRCP, FFPM</au><au>Kastelein, John J.P., MD, PhD</au><aucorp>PASCAL Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and Safety of Pitavastatin in Children and Adolescents at High Future Cardiovascular Risk</atitle><jtitle>The Journal of pediatrics</jtitle><addtitle>J Pediatr</addtitle><date>2015-08-01</date><risdate>2015</risdate><volume>167</volume><issue>2</issue><spage>338</spage><epage>343.e5</epage><pages>338-343.e5</pages><issn>0022-3476</issn><eissn>1097-6833</eissn><abstract>Objectives To assess the safety and efficacy of pitavastatin in children and adolescents with hyperlipidemia. Study design A total of 106 children and adolescents with hyperlipidemia, ages 6 to 17 years, were enrolled in a 12-week randomized, double-blind, placebo-controlled study and randomly assigned to pitavastatin 1 mg, 2 mg, 4 mg, or placebo. During a 52-week extension period, subjects were up-titrated from 1 mg pitavastatin to a maximum dose of 4 mg in an effort to achieve an optimum low-density lipoprotein cholesterol (LDL-C) treatment target of <110 mg/dL (2.8 mmol/L). Adverse events rates, including abnormal clinical laboratory variables, vital signs, and physical examination were assessed. Results Compared with placebo, pitavastatin 1, 2, and 4 mg significantly reduced LDL-C from baseline by 23.5%, 30.1%, and 39.3%, respectively, and in the open-label study 20.5% of the subjects reached the LDL-C goal <110 mg/dL (2.8 mmol/L). No safety issues were evident. Conclusions Pitavastatin at doses up to 4 mg is well tolerated and efficacious in children and adolescents aged 6-17 years. Trial registration Registered with EudraCT 2011-004964-32 and EudraCT 2011-004983-32.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>26059337</pmid><doi>10.1016/j.jpeds.2015.05.006</doi></addata></record> |
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| subjects | Adolescent Age Factors Apolipoproteins - blood Cardiovascular Diseases - blood Cardiovascular Diseases - etiology Child Cholesterol - blood Dose-Response Relationship, Drug Double-Blind Method Europe Female Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - pharmacokinetics Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use Hyperlipidemias - blood Hyperlipidemias - drug therapy Male Pediatrics Quinolines - pharmacokinetics Quinolines - therapeutic use Risk Factors Treatment Outcome Triglycerides - blood |
| title | Efficacy and Safety of Pitavastatin in Children and Adolescents at High Future Cardiovascular Risk |
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