Statins and congenital malformations: cohort study
Objective To examine the teratogenic potential of statins.Design Cohort study.Setting United States.Participants A cohort of 886 996 completed pregnancies linked to liveborn infants of women enrolled in Medicaid from 2000 to 2007.Methods We examined the risk of major congenital malformations and org...
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| Veröffentlicht in: | BMJ (Online) 2015-03, Vol.350 (mar17 10), p.h1035-h1035 |
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| creator | Bateman, Brian T Hernandez-Diaz, Sonia Fischer, Michael A Seely, Ellen W Ecker, Jeffrey L Franklin, Jessica M Desai, Rishi J Allen-Coleman, Cora Mogun, Helen Avorn, Jerry Huybrechts, Krista F |
| description | Objective To examine the teratogenic potential of statins.Design Cohort study.Setting United States.Participants A cohort of 886 996 completed pregnancies linked to liveborn infants of women enrolled in Medicaid from 2000 to 2007.Methods We examined the risk of major congenital malformations and organ specific malformations in offspring associated with maternal use of a statin in the first trimester. Propensity score based methods were used to control for potential confounders, including maternal demographic characteristics, obstetric and medical conditions, and use of other drugs.Results 1152 (0.13%) women used a statin during the first trimester. In unadjusted analyses, the prevalence of malformations in the offspring of these women was 6.34% compared with 3.55% in those of women who did not use a statin in the first trimester (relative risk 1.79, 95% confidence interval 1.43 to 2.23). Controlling for confounders, particularly pre-existing diabetes, accounted for this increase in risk (1.07, 0.85 to 1.37). There were also no statistically significant increases in any of the organ specific malformations assessed after accounting for confounders. Results were similar across a range of sensitivity analyses.Conclusions Our analysis did not find a significant teratogenic effect from maternal use of statins in the first trimester. However, these findings need to be replicated in other large studies, and the long term effects of in utero exposure to statins needs to be assessed, before use of statins in pregnancy can be considered safe. |
| doi_str_mv | 10.1136/bmj.h1035 |
| format | Article |
| fullrecord | <record><control><sourceid>jstor_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4362473</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><jstor_id>26520287</jstor_id><sourcerecordid>26520287</sourcerecordid><originalsourceid>FETCH-LOGICAL-b520t-494280f89118b1a8a14a8ab7de89f4b6a98ef143ac356a881903a52affd7e0703</originalsourceid><addsrcrecordid>eNp1kUtrGzEUhUVIiU2aRX9AiyFdpItJ9dadLArBtE0gkEXTtdDMaOIxM5IjaQr-95Vjx3lAtJAW5-Pcq3MQ-kTwOSFMfq-G5fmCYCYO0JQoIQsCjB2iKS5FWQBhMEEnMS4xxpQpKKU4QhMqFHAJMEX0TzKpc3FmXDOrvbu3rkumnw2mb30YsuZdvMjKwoc0i2ls1h_Rh9b00Z7s3mP099fPu_lVcXP7-3p-eVNUguJU8JJTwC2UhEBFDBjC81WpxkLZ8kqaEmxLODM1E9IAkBIzI6hp20ZZrDA7Rj-2vquxGmxTW5eC6fUqdIMJa-1Np18rrlvoe_9PcyYpVywbnO0Mgn8YbUx66GJt-94468eoiZRcKQF8g56-QZd-DC5_TxOVj6Q5vEx921J18DEG2-6XIVhvytC5DP1YRma_vNx-Tz5Fn4HPW2AZkw_PuszpUdgM-7rVN57vz_kPXEWZ6w</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1777762237</pqid></control><display><type>article</type><title>Statins and congenital malformations: cohort study</title><source>Jstor Complete Legacy</source><source>MEDLINE</source><source>BMJ Journals - NESLi2</source><creator>Bateman, Brian T ; Hernandez-Diaz, Sonia ; Fischer, Michael A ; Seely, Ellen W ; Ecker, Jeffrey L ; Franklin, Jessica M ; Desai, Rishi J ; Allen-Coleman, Cora ; Mogun, Helen ; Avorn, Jerry ; Huybrechts, Krista F</creator><creatorcontrib>Bateman, Brian T ; Hernandez-Diaz, Sonia ; Fischer, Michael A ; Seely, Ellen W ; Ecker, Jeffrey L ; Franklin, Jessica M ; Desai, Rishi J ; Allen-Coleman, Cora ; Mogun, Helen ; Avorn, Jerry ; Huybrechts, Krista F</creatorcontrib><description>Objective To examine the teratogenic potential of statins.Design Cohort study.Setting United States.Participants A cohort of 886 996 completed pregnancies linked to liveborn infants of women enrolled in Medicaid from 2000 to 2007.Methods We examined the risk of major congenital malformations and organ specific malformations in offspring associated with maternal use of a statin in the first trimester. Propensity score based methods were used to control for potential confounders, including maternal demographic characteristics, obstetric and medical conditions, and use of other drugs.Results 1152 (0.13%) women used a statin during the first trimester. In unadjusted analyses, the prevalence of malformations in the offspring of these women was 6.34% compared with 3.55% in those of women who did not use a statin in the first trimester (relative risk 1.79, 95% confidence interval 1.43 to 2.23). Controlling for confounders, particularly pre-existing diabetes, accounted for this increase in risk (1.07, 0.85 to 1.37). There were also no statistically significant increases in any of the organ specific malformations assessed after accounting for confounders. Results were similar across a range of sensitivity analyses.Conclusions Our analysis did not find a significant teratogenic effect from maternal use of statins in the first trimester. However, these findings need to be replicated in other large studies, and the long term effects of in utero exposure to statins needs to be assessed, before use of statins in pregnancy can be considered safe.</description><identifier>ISSN: 0959-8138</identifier><identifier>ISSN: 1756-1833</identifier><identifier>EISSN: 1756-1833</identifier><identifier>DOI: 10.1136/bmj.h1035</identifier><identifier>PMID: 25784688</identifier><language>eng</language><publisher>England: British Medical Journal Publishing Group</publisher><subject>Abnormalities, Drug-Induced - epidemiology ; Abnormalities, Drug-Induced - etiology ; Adolescent ; Adult ; Babies ; Beneficiaries ; Birth defects ; Child ; Cohort Studies ; Comorbidity ; Confidence intervals ; Congenital diseases ; Diabetes ; Female ; Health services utilization ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects ; Hypertension ; Medicaid ; Menstruation ; Middle Aged ; Nervous system ; Obstetrics ; Pregnancy ; Pregnancy Trimester, First ; Prescription drugs ; Prevalence ; Propensity Score ; Risk Factors ; Statins ; United States - epidemiology ; Womens health ; Young Adult</subject><ispartof>BMJ (Online), 2015-03, Vol.350 (mar17 10), p.h1035-h1035</ispartof><rights>Bateman et al 2015</rights><rights>BMJ Publishing Group Ltd 2015</rights><rights>Bateman et al 2015.</rights><rights>Copyright BMJ Publishing Group LTD Mar 17, 2015</rights><rights>Bateman et al 2015 2015 Bateman et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b520t-494280f89118b1a8a14a8ab7de89f4b6a98ef143ac356a881903a52affd7e0703</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://bmj.com/content/350/bmj.h1035.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttp://bmj.com/content/350/bmj.h1035.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>114,115,230,314,776,780,799,881,3183,23550,27901,27902,57992,58225,77343,77374</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25784688$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bateman, Brian T</creatorcontrib><creatorcontrib>Hernandez-Diaz, Sonia</creatorcontrib><creatorcontrib>Fischer, Michael A</creatorcontrib><creatorcontrib>Seely, Ellen W</creatorcontrib><creatorcontrib>Ecker, Jeffrey L</creatorcontrib><creatorcontrib>Franklin, Jessica M</creatorcontrib><creatorcontrib>Desai, Rishi J</creatorcontrib><creatorcontrib>Allen-Coleman, Cora</creatorcontrib><creatorcontrib>Mogun, Helen</creatorcontrib><creatorcontrib>Avorn, Jerry</creatorcontrib><creatorcontrib>Huybrechts, Krista F</creatorcontrib><title>Statins and congenital malformations: cohort study</title><title>BMJ (Online)</title><addtitle>BMJ</addtitle><description>Objective To examine the teratogenic potential of statins.Design Cohort study.Setting United States.Participants A cohort of 886 996 completed pregnancies linked to liveborn infants of women enrolled in Medicaid from 2000 to 2007.Methods We examined the risk of major congenital malformations and organ specific malformations in offspring associated with maternal use of a statin in the first trimester. Propensity score based methods were used to control for potential confounders, including maternal demographic characteristics, obstetric and medical conditions, and use of other drugs.Results 1152 (0.13%) women used a statin during the first trimester. In unadjusted analyses, the prevalence of malformations in the offspring of these women was 6.34% compared with 3.55% in those of women who did not use a statin in the first trimester (relative risk 1.79, 95% confidence interval 1.43 to 2.23). Controlling for confounders, particularly pre-existing diabetes, accounted for this increase in risk (1.07, 0.85 to 1.37). There were also no statistically significant increases in any of the organ specific malformations assessed after accounting for confounders. Results were similar across a range of sensitivity analyses.Conclusions Our analysis did not find a significant teratogenic effect from maternal use of statins in the first trimester. However, these findings need to be replicated in other large studies, and the long term effects of in utero exposure to statins needs to be assessed, before use of statins in pregnancy can be considered safe.</description><subject>Abnormalities, Drug-Induced - epidemiology</subject><subject>Abnormalities, Drug-Induced - etiology</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Babies</subject><subject>Beneficiaries</subject><subject>Birth defects</subject><subject>Child</subject><subject>Cohort Studies</subject><subject>Comorbidity</subject><subject>Confidence intervals</subject><subject>Congenital diseases</subject><subject>Diabetes</subject><subject>Female</subject><subject>Health services utilization</subject><subject>Humans</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects</subject><subject>Hypertension</subject><subject>Medicaid</subject><subject>Menstruation</subject><subject>Middle Aged</subject><subject>Nervous system</subject><subject>Obstetrics</subject><subject>Pregnancy</subject><subject>Pregnancy Trimester, First</subject><subject>Prescription drugs</subject><subject>Prevalence</subject><subject>Propensity Score</subject><subject>Risk Factors</subject><subject>Statins</subject><subject>United States - epidemiology</subject><subject>Womens health</subject><subject>Young Adult</subject><issn>0959-8138</issn><issn>1756-1833</issn><issn>1756-1833</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp1kUtrGzEUhUVIiU2aRX9AiyFdpItJ9dadLArBtE0gkEXTtdDMaOIxM5IjaQr-95Vjx3lAtJAW5-Pcq3MQ-kTwOSFMfq-G5fmCYCYO0JQoIQsCjB2iKS5FWQBhMEEnMS4xxpQpKKU4QhMqFHAJMEX0TzKpc3FmXDOrvbu3rkumnw2mb30YsuZdvMjKwoc0i2ls1h_Rh9b00Z7s3mP099fPu_lVcXP7-3p-eVNUguJU8JJTwC2UhEBFDBjC81WpxkLZ8kqaEmxLODM1E9IAkBIzI6hp20ZZrDA7Rj-2vquxGmxTW5eC6fUqdIMJa-1Np18rrlvoe_9PcyYpVywbnO0Mgn8YbUx66GJt-94468eoiZRcKQF8g56-QZd-DC5_TxOVj6Q5vEx921J18DEG2-6XIVhvytC5DP1YRma_vNx-Tz5Fn4HPW2AZkw_PuszpUdgM-7rVN57vz_kPXEWZ6w</recordid><startdate>20150317</startdate><enddate>20150317</enddate><creator>Bateman, Brian T</creator><creator>Hernandez-Diaz, Sonia</creator><creator>Fischer, Michael A</creator><creator>Seely, Ellen W</creator><creator>Ecker, Jeffrey L</creator><creator>Franklin, Jessica M</creator><creator>Desai, Rishi J</creator><creator>Allen-Coleman, Cora</creator><creator>Mogun, Helen</creator><creator>Avorn, Jerry</creator><creator>Huybrechts, Krista F</creator><general>British Medical Journal Publishing Group</general><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group Ltd</general><scope>9YT</scope><scope>ACMMV</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>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88I</scope><scope>8AF</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ASE</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FPQ</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K6X</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M2O</scope><scope>M2P</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20150317</creationdate><title>Statins and congenital malformations: cohort study</title><author>Bateman, Brian T ; Hernandez-Diaz, Sonia ; Fischer, Michael A ; Seely, Ellen W ; Ecker, Jeffrey L ; Franklin, Jessica M ; Desai, Rishi J ; Allen-Coleman, Cora ; Mogun, Helen ; Avorn, Jerry ; Huybrechts, Krista F</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b520t-494280f89118b1a8a14a8ab7de89f4b6a98ef143ac356a881903a52affd7e0703</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Abnormalities, Drug-Induced - epidemiology</topic><topic>Abnormalities, Drug-Induced - etiology</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Babies</topic><topic>Beneficiaries</topic><topic>Birth defects</topic><topic>Child</topic><topic>Cohort Studies</topic><topic>Comorbidity</topic><topic>Confidence intervals</topic><topic>Congenital diseases</topic><topic>Diabetes</topic><topic>Female</topic><topic>Health services utilization</topic><topic>Humans</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects</topic><topic>Hypertension</topic><topic>Medicaid</topic><topic>Menstruation</topic><topic>Middle Aged</topic><topic>Nervous system</topic><topic>Obstetrics</topic><topic>Pregnancy</topic><topic>Pregnancy Trimester, First</topic><topic>Prescription drugs</topic><topic>Prevalence</topic><topic>Propensity Score</topic><topic>Risk Factors</topic><topic>Statins</topic><topic>United States - epidemiology</topic><topic>Womens health</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bateman, Brian T</creatorcontrib><creatorcontrib>Hernandez-Diaz, Sonia</creatorcontrib><creatorcontrib>Fischer, Michael A</creatorcontrib><creatorcontrib>Seely, Ellen W</creatorcontrib><creatorcontrib>Ecker, Jeffrey L</creatorcontrib><creatorcontrib>Franklin, Jessica M</creatorcontrib><creatorcontrib>Desai, Rishi J</creatorcontrib><creatorcontrib>Allen-Coleman, Cora</creatorcontrib><creatorcontrib>Mogun, Helen</creatorcontrib><creatorcontrib>Avorn, Jerry</creatorcontrib><creatorcontrib>Huybrechts, Krista F</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</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>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Index</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>British Nursing Index (BNI) (1985 to Present)</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>SciTech Premium Collection</collection><collection>British Nursing Index</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Research Library</collection><collection>Science Database</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</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>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ (Online)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bateman, Brian T</au><au>Hernandez-Diaz, Sonia</au><au>Fischer, Michael A</au><au>Seely, Ellen W</au><au>Ecker, Jeffrey L</au><au>Franklin, Jessica M</au><au>Desai, Rishi J</au><au>Allen-Coleman, Cora</au><au>Mogun, Helen</au><au>Avorn, Jerry</au><au>Huybrechts, Krista F</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Statins and congenital malformations: cohort study</atitle><jtitle>BMJ (Online)</jtitle><addtitle>BMJ</addtitle><date>2015-03-17</date><risdate>2015</risdate><volume>350</volume><issue>mar17 10</issue><spage>h1035</spage><epage>h1035</epage><pages>h1035-h1035</pages><issn>0959-8138</issn><issn>1756-1833</issn><eissn>1756-1833</eissn><abstract>Objective To examine the teratogenic potential of statins.Design Cohort study.Setting United States.Participants A cohort of 886 996 completed pregnancies linked to liveborn infants of women enrolled in Medicaid from 2000 to 2007.Methods We examined the risk of major congenital malformations and organ specific malformations in offspring associated with maternal use of a statin in the first trimester. Propensity score based methods were used to control for potential confounders, including maternal demographic characteristics, obstetric and medical conditions, and use of other drugs.Results 1152 (0.13%) women used a statin during the first trimester. In unadjusted analyses, the prevalence of malformations in the offspring of these women was 6.34% compared with 3.55% in those of women who did not use a statin in the first trimester (relative risk 1.79, 95% confidence interval 1.43 to 2.23). Controlling for confounders, particularly pre-existing diabetes, accounted for this increase in risk (1.07, 0.85 to 1.37). There were also no statistically significant increases in any of the organ specific malformations assessed after accounting for confounders. Results were similar across a range of sensitivity analyses.Conclusions Our analysis did not find a significant teratogenic effect from maternal use of statins in the first trimester. However, these findings need to be replicated in other large studies, and the long term effects of in utero exposure to statins needs to be assessed, before use of statins in pregnancy can be considered safe.</abstract><cop>England</cop><pub>British Medical Journal Publishing Group</pub><pmid>25784688</pmid><doi>10.1136/bmj.h1035</doi><oa>free_for_read</oa></addata></record> |
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| subjects | Abnormalities, Drug-Induced - epidemiology Abnormalities, Drug-Induced - etiology Adolescent Adult Babies Beneficiaries Birth defects Child Cohort Studies Comorbidity Confidence intervals Congenital diseases Diabetes Female Health services utilization Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects Hypertension Medicaid Menstruation Middle Aged Nervous system Obstetrics Pregnancy Pregnancy Trimester, First Prescription drugs Prevalence Propensity Score Risk Factors Statins United States - epidemiology Womens health Young Adult |
| title | Statins and congenital malformations: cohort study |
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