Conducting omega-3 clinical trials with cardiovascular outcomes: Proceedings of a workshop held at ISSFAL 2014
Abstract In contrast to earlier long-chain (LC) omega-3 (i.e. EPA and DHA) investigations, some recent studies have not demonstrated significant effects of EPA and DHA on cardiovascular disease (CVD) outcomes. The neutral findings may have been due to experimental design issues, such as: maintenance...
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| Veröffentlicht in: | Prostaglandins, leukotrienes and essential fatty acids leukotrienes and essential fatty acids, 2016-04, Vol.107, p.30-42 |
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| container_title | Prostaglandins, leukotrienes and essential fatty acids |
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| creator | Rice, Harry B Bernasconi, Aldo Maki, Kevin C Harris, William S von Schacky, Clemens Calder, Philip C |
| description | Abstract In contrast to earlier long-chain (LC) omega-3 (i.e. EPA and DHA) investigations, some recent studies have not demonstrated significant effects of EPA and DHA on cardiovascular disease (CVD) outcomes. The neutral findings may have been due to experimental design issues, such as: maintenance on aggressive cardiovascular drug treatment overshadowing the benefits of LC omega-3s, high background LC omega-3 intake, too few subjects in the study, treatment duration too short, insufficient LC omega-3 dosage, increase in omega-6 fatty acid intake during the study, failure to assess the LC omega-3 status of the subjects prior to and during treatment and lack of clarity concerning which mechanisms were expected to produce benefits. At the 11th ISSFAL Congress, a workshop was held on conducting LC omega-3 clinical trials with cardiovascular outcomes, with the goal of gaining a better understanding concerning aspects of experimental design that should be considered when planning clinical studies related to EPA and DHA and potential cardiovascular benefits. |
| doi_str_mv | 10.1016/j.plefa.2016.01.003 |
| format | Article |
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The neutral findings may have been due to experimental design issues, such as: maintenance on aggressive cardiovascular drug treatment overshadowing the benefits of LC omega-3s, high background LC omega-3 intake, too few subjects in the study, treatment duration too short, insufficient LC omega-3 dosage, increase in omega-6 fatty acid intake during the study, failure to assess the LC omega-3 status of the subjects prior to and during treatment and lack of clarity concerning which mechanisms were expected to produce benefits. At the 11th ISSFAL Congress, a workshop was held on conducting LC omega-3 clinical trials with cardiovascular outcomes, with the goal of gaining a better understanding concerning aspects of experimental design that should be considered when planning clinical studies related to EPA and DHA and potential cardiovascular benefits.</description><identifier>ISSN: 0952-3278</identifier><identifier>EISSN: 1532-2823</identifier><identifier>DOI: 10.1016/j.plefa.2016.01.003</identifier><identifier>PMID: 26858145</identifier><language>eng</language><publisher>Scotland: Elsevier Ltd</publisher><subject>Advanced Basic Science ; Cardiovascular Agents - pharmacokinetics ; Cardiovascular Agents - therapeutic use ; Cardiovascular disease ; Cardiovascular Diseases - drug therapy ; Data Interpretation, Statistical ; Design ; Dietary Supplements ; Docosahexaenic ; Eicosapentaenoic ; Endocrinology & Metabolism ; Fatty Acids, Omega-3 - pharmacokinetics ; Fatty Acids, Omega-3 - therapeutic use ; Humans ; Omega-3 ; Randomized Controlled Trials as Topic ; Sample Size ; Treatment Outcome</subject><ispartof>Prostaglandins, leukotrienes and essential fatty acids, 2016-04, Vol.107, p.30-42</ispartof><rights>The Authors</rights><rights>2016 The Authors</rights><rights>Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c459t-d6c65c14ee9bbc4135726dc60b559d9635884ff58e53738e3f2df09fb31bda333</citedby><cites>FETCH-LOGICAL-c459t-d6c65c14ee9bbc4135726dc60b559d9635884ff58e53738e3f2df09fb31bda333</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0952327815300132$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26858145$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rice, Harry B</creatorcontrib><creatorcontrib>Bernasconi, Aldo</creatorcontrib><creatorcontrib>Maki, Kevin C</creatorcontrib><creatorcontrib>Harris, William S</creatorcontrib><creatorcontrib>von Schacky, Clemens</creatorcontrib><creatorcontrib>Calder, Philip C</creatorcontrib><title>Conducting omega-3 clinical trials with cardiovascular outcomes: Proceedings of a workshop held at ISSFAL 2014</title><title>Prostaglandins, leukotrienes and essential fatty acids</title><addtitle>Prostaglandins Leukot Essent Fatty Acids</addtitle><description>Abstract In contrast to earlier long-chain (LC) omega-3 (i.e. EPA and DHA) investigations, some recent studies have not demonstrated significant effects of EPA and DHA on cardiovascular disease (CVD) outcomes. The neutral findings may have been due to experimental design issues, such as: maintenance on aggressive cardiovascular drug treatment overshadowing the benefits of LC omega-3s, high background LC omega-3 intake, too few subjects in the study, treatment duration too short, insufficient LC omega-3 dosage, increase in omega-6 fatty acid intake during the study, failure to assess the LC omega-3 status of the subjects prior to and during treatment and lack of clarity concerning which mechanisms were expected to produce benefits. 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| subjects | Advanced Basic Science Cardiovascular Agents - pharmacokinetics Cardiovascular Agents - therapeutic use Cardiovascular disease Cardiovascular Diseases - drug therapy Data Interpretation, Statistical Design Dietary Supplements Docosahexaenic Eicosapentaenoic Endocrinology & Metabolism Fatty Acids, Omega-3 - pharmacokinetics Fatty Acids, Omega-3 - therapeutic use Humans Omega-3 Randomized Controlled Trials as Topic Sample Size Treatment Outcome |
| title | Conducting omega-3 clinical trials with cardiovascular outcomes: Proceedings of a workshop held at ISSFAL 2014 |
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