Impact of selective serotonin reuptake inhibitor therapy on heart valves in patients exposed to benfluorex: A multicentre study

Summary Background Given the association between valvular heart disease and drugs that alter serotonin metabolism, concerns have been raised about the possibility of an association between selective serotonin reuptake inhibitor (SSRI) use and drug-induced valvular disease. In France, SSRI use has be...

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Veröffentlicht in:Archives of cardiovascular diseases 2013-06, Vol.106 (6), p.349-356
Hauptverfasser: Maréchaux, Sylvestre, Jeu, Antoine, Jobic, Yannick, Ederhy, Stéphane, Donal, Erwan, Réant, Patricia, Abouth, Shirley, Arnasteen, Elise, Boulanger, Jacques, Ennezat, Pierre-Vladimir, Garban, Thierry, Szymanski, Catherine, Tribouilloy, Christophe
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container_end_page 356
container_issue 6
container_start_page 349
container_title Archives of cardiovascular diseases
container_volume 106
creator Maréchaux, Sylvestre
Jeu, Antoine
Jobic, Yannick
Ederhy, Stéphane
Donal, Erwan
Réant, Patricia
Abouth, Shirley
Arnasteen, Elise
Boulanger, Jacques
Ennezat, Pierre-Vladimir
Garban, Thierry
Szymanski, Catherine
Tribouilloy, Christophe
description Summary Background Given the association between valvular heart disease and drugs that alter serotonin metabolism, concerns have been raised about the possibility of an association between selective serotonin reuptake inhibitor (SSRI) use and drug-induced valvular disease. In France, SSRI use has been suggested to be an important confounding factor in the development of heart valve lesions in patients exposed to benfluorex in the context of the ‘Médiator scandal’. Aims To address the relationship between SSRI use and valve regurgitation and morphology in a large cohort of patients exposed to benfluorex. Methods Overall, 832 consecutive patients exposed to benfluorex prospectively referred to 10 centres underwent complete echocardiography examinations according to a standardized protocol. Echocardiograms were independently and blindly read off-line by two experts. Results Ninety patients had been exposed to SSRIs for 3 months or more. The proportions of patients with no or trivial, mild, moderate or severe mitral regurgitation (MR) or aortic regurgitation (AR) were not different between SSRI patients and non-SSRI patients ( P = 0.63 and 0.58, respectively). The frequencies of AR ≥ mild (20 [22.2%] vs 145 [19.5%]; P = 0.55) and MR ≥ mild (14 [15.6%] vs 118 [15.9%]; P = 0.93) were similar in SSRI patients and non-SSRI patients. The frequencies of aortic and mitral valve abnormalities suggestive of drug-induced toxicity were also similar in the two patient groups. Multivariable logistic regression analysis confirmed the absence of any identifiable relationship between AR or MR and morphological abnormalities and SSRI use in the present cohort. Conclusion Exposure to SSRIs was not associated with an increased risk of heart valve regurgitation or morphological abnormalities suggestive of drug-induced toxicity in this large cohort of patients exposed to benfluorex.
doi_str_mv 10.1016/j.acvd.2013.04.006
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In France, SSRI use has been suggested to be an important confounding factor in the development of heart valve lesions in patients exposed to benfluorex in the context of the ‘Médiator scandal’. Aims To address the relationship between SSRI use and valve regurgitation and morphology in a large cohort of patients exposed to benfluorex. Methods Overall, 832 consecutive patients exposed to benfluorex prospectively referred to 10 centres underwent complete echocardiography examinations according to a standardized protocol. Echocardiograms were independently and blindly read off-line by two experts. Results Ninety patients had been exposed to SSRIs for 3 months or more. The proportions of patients with no or trivial, mild, moderate or severe mitral regurgitation (MR) or aortic regurgitation (AR) were not different between SSRI patients and non-SSRI patients ( P = 0.63 and 0.58, respectively). The frequencies of AR ≥ mild (20 [22.2%] vs 145 [19.5%]; P = 0.55) and MR ≥ mild (14 [15.6%] vs 118 [15.9%]; P = 0.93) were similar in SSRI patients and non-SSRI patients. The frequencies of aortic and mitral valve abnormalities suggestive of drug-induced toxicity were also similar in the two patient groups. Multivariable logistic regression analysis confirmed the absence of any identifiable relationship between AR or MR and morphological abnormalities and SSRI use in the present cohort. Conclusion Exposure to SSRIs was not associated with an increased risk of heart valve regurgitation or morphological abnormalities suggestive of drug-induced toxicity in this large cohort of patients exposed to benfluorex.</description><identifier>ISSN: 1875-2136</identifier><identifier>EISSN: 1875-2128</identifier><identifier>DOI: 10.1016/j.acvd.2013.04.006</identifier><identifier>PMID: 23876809</identifier><language>eng</language><publisher>Netherlands: Elsevier Masson SAS</publisher><subject>Adult ; Aged ; Aortic Valve - drug effects ; Aortic Valve Insufficiency - chemically induced ; Appetite Depressants - adverse effects ; Benfluorex ; Cardiovascular ; Chi-Square Distribution ; Drug-induced valvular disease ; Echocardiography ; Echocardiography, Doppler, Color ; Female ; Fenfluramine - adverse effects ; Fenfluramine - analogs &amp; derivatives ; France ; Heart Valve Diseases - chemically induced ; Heart Valve Diseases - diagnostic imaging ; Heart Valve Diseases - physiopathology ; Heart Valves - diagnostic imaging ; Heart Valves - drug effects ; Heart Valves - physiopathology ; Humans ; Inhibiteurs spécifiques de la recapture de la sérotonine ; Internal Medicine ; Logistic Models ; Maladies valvulaires induites par les médicaments ; Male ; Middle Aged ; Mitral Valve - drug effects ; Mitral Valve Insufficiency - chemically induced ; Multivariate Analysis ; Observer Variation ; Predictive Value of Tests ; Prospective Studies ; Referral and Consultation ; Reproducibility of Results ; Risk Assessment ; Risk Factors ; Selective serotonin reuptake inhibitor therapy ; Serotonin Uptake Inhibitors - adverse effects ; Time Factors ; Tricuspid Valve - drug effects ; Tricuspid Valve Insufficiency - chemically induced ; Échocardiographie</subject><ispartof>Archives of cardiovascular diseases, 2013-06, Vol.106 (6), p.349-356</ispartof><rights>Elsevier Masson SAS</rights><rights>2013 Elsevier Masson SAS</rights><rights>Copyright © 2013 Elsevier Masson SAS. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c411t-2f65cf0d4422064fd8292a5fcc8db31a225d1cf157e8443d282ac8720966e9e63</citedby><cites>FETCH-LOGICAL-c411t-2f65cf0d4422064fd8292a5fcc8db31a225d1cf157e8443d282ac8720966e9e63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.acvd.2013.04.006$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23876809$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Maréchaux, Sylvestre</creatorcontrib><creatorcontrib>Jeu, Antoine</creatorcontrib><creatorcontrib>Jobic, Yannick</creatorcontrib><creatorcontrib>Ederhy, Stéphane</creatorcontrib><creatorcontrib>Donal, Erwan</creatorcontrib><creatorcontrib>Réant, Patricia</creatorcontrib><creatorcontrib>Abouth, Shirley</creatorcontrib><creatorcontrib>Arnasteen, Elise</creatorcontrib><creatorcontrib>Boulanger, Jacques</creatorcontrib><creatorcontrib>Ennezat, Pierre-Vladimir</creatorcontrib><creatorcontrib>Garban, Thierry</creatorcontrib><creatorcontrib>Szymanski, Catherine</creatorcontrib><creatorcontrib>Tribouilloy, Christophe</creatorcontrib><title>Impact of selective serotonin reuptake inhibitor therapy on heart valves in patients exposed to benfluorex: A multicentre study</title><title>Archives of cardiovascular diseases</title><addtitle>Arch Cardiovasc Dis</addtitle><description>Summary Background Given the association between valvular heart disease and drugs that alter serotonin metabolism, concerns have been raised about the possibility of an association between selective serotonin reuptake inhibitor (SSRI) use and drug-induced valvular disease. In France, SSRI use has been suggested to be an important confounding factor in the development of heart valve lesions in patients exposed to benfluorex in the context of the ‘Médiator scandal’. Aims To address the relationship between SSRI use and valve regurgitation and morphology in a large cohort of patients exposed to benfluorex. Methods Overall, 832 consecutive patients exposed to benfluorex prospectively referred to 10 centres underwent complete echocardiography examinations according to a standardized protocol. Echocardiograms were independently and blindly read off-line by two experts. Results Ninety patients had been exposed to SSRIs for 3 months or more. The proportions of patients with no or trivial, mild, moderate or severe mitral regurgitation (MR) or aortic regurgitation (AR) were not different between SSRI patients and non-SSRI patients ( P = 0.63 and 0.58, respectively). The frequencies of AR ≥ mild (20 [22.2%] vs 145 [19.5%]; P = 0.55) and MR ≥ mild (14 [15.6%] vs 118 [15.9%]; P = 0.93) were similar in SSRI patients and non-SSRI patients. The frequencies of aortic and mitral valve abnormalities suggestive of drug-induced toxicity were also similar in the two patient groups. Multivariable logistic regression analysis confirmed the absence of any identifiable relationship between AR or MR and morphological abnormalities and SSRI use in the present cohort. Conclusion Exposure to SSRIs was not associated with an increased risk of heart valve regurgitation or morphological abnormalities suggestive of drug-induced toxicity in this large cohort of patients exposed to benfluorex.</description><subject>Adult</subject><subject>Aged</subject><subject>Aortic Valve - drug effects</subject><subject>Aortic Valve Insufficiency - chemically induced</subject><subject>Appetite Depressants - adverse effects</subject><subject>Benfluorex</subject><subject>Cardiovascular</subject><subject>Chi-Square Distribution</subject><subject>Drug-induced valvular disease</subject><subject>Echocardiography</subject><subject>Echocardiography, Doppler, Color</subject><subject>Female</subject><subject>Fenfluramine - adverse effects</subject><subject>Fenfluramine - analogs &amp; derivatives</subject><subject>France</subject><subject>Heart Valve Diseases - chemically induced</subject><subject>Heart Valve Diseases - diagnostic imaging</subject><subject>Heart Valve Diseases - physiopathology</subject><subject>Heart Valves - diagnostic imaging</subject><subject>Heart Valves - drug effects</subject><subject>Heart Valves - physiopathology</subject><subject>Humans</subject><subject>Inhibiteurs spécifiques de la recapture de la sérotonine</subject><subject>Internal Medicine</subject><subject>Logistic Models</subject><subject>Maladies valvulaires induites par les médicaments</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Mitral Valve - drug effects</subject><subject>Mitral Valve Insufficiency - chemically induced</subject><subject>Multivariate Analysis</subject><subject>Observer Variation</subject><subject>Predictive Value of Tests</subject><subject>Prospective Studies</subject><subject>Referral and Consultation</subject><subject>Reproducibility of Results</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><subject>Selective serotonin reuptake inhibitor therapy</subject><subject>Serotonin Uptake Inhibitors - adverse effects</subject><subject>Time Factors</subject><subject>Tricuspid Valve - drug effects</subject><subject>Tricuspid Valve Insufficiency - chemically induced</subject><subject>Échocardiographie</subject><issn>1875-2136</issn><issn>1875-2128</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kcFu1DAURS0EoqXwAyyQl2wmtR3HSRBCqiqglSqxaFlbHvtF46ljB9uJOit-HUdTuuiiK7_FuffJ5yH0kZKKEirO95XSi6kYoXVFeEWIeIVOadc2G0ZZ9_pprsUJepfSvgCsbcVbdMLqrhUd6U_R3-txUjrjMOAEDnS2C5Qphhy89TjCPGV1D9j6nd3aHCLOO4hqOuDg8Q5UzHhRboFUCDypbMHnhOFhCgkMzgFvwQ9uDhEevuALPM4uW12YWLbk2RzeozeDcgk-PL5n6PeP73eXV5ubXz-vLy9uNppTmjdsEI0eiOGcMSL4YDrWM9UMWndmW1PFWGOoHmjTQsd5bVjHlO5aRnohoAdRn6HPx94phj8zpCxHmzQ4pzyEOUnKKaNN05OmoOyI6hhSijDIKdpRxYOkRK7i5V6u4uUqXhIui9cS-vTYP29HME-R_6YL8PUIQPnlYiHKpIssDcbGol2aYF_u__Ysrp31Vit3DwdI-zBHX_xJKhOTRN6up18vT2tCKO9F_Q_ia6tp</recordid><startdate>20130601</startdate><enddate>20130601</enddate><creator>Maréchaux, Sylvestre</creator><creator>Jeu, Antoine</creator><creator>Jobic, Yannick</creator><creator>Ederhy, Stéphane</creator><creator>Donal, Erwan</creator><creator>Réant, Patricia</creator><creator>Abouth, Shirley</creator><creator>Arnasteen, Elise</creator><creator>Boulanger, Jacques</creator><creator>Ennezat, Pierre-Vladimir</creator><creator>Garban, Thierry</creator><creator>Szymanski, Catherine</creator><creator>Tribouilloy, Christophe</creator><general>Elsevier Masson SAS</general><scope>6I.</scope><scope>AAFTH</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>7X8</scope></search><sort><creationdate>20130601</creationdate><title>Impact of selective serotonin reuptake inhibitor therapy on heart valves in patients exposed to benfluorex: A multicentre study</title><author>Maréchaux, Sylvestre ; Jeu, Antoine ; Jobic, Yannick ; Ederhy, Stéphane ; Donal, Erwan ; Réant, Patricia ; Abouth, Shirley ; Arnasteen, Elise ; Boulanger, Jacques ; Ennezat, Pierre-Vladimir ; Garban, Thierry ; Szymanski, Catherine ; Tribouilloy, Christophe</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c411t-2f65cf0d4422064fd8292a5fcc8db31a225d1cf157e8443d282ac8720966e9e63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aortic Valve - drug effects</topic><topic>Aortic Valve Insufficiency - chemically induced</topic><topic>Appetite Depressants - adverse effects</topic><topic>Benfluorex</topic><topic>Cardiovascular</topic><topic>Chi-Square Distribution</topic><topic>Drug-induced valvular disease</topic><topic>Echocardiography</topic><topic>Echocardiography, Doppler, Color</topic><topic>Female</topic><topic>Fenfluramine - adverse effects</topic><topic>Fenfluramine - analogs &amp; derivatives</topic><topic>France</topic><topic>Heart Valve Diseases - chemically induced</topic><topic>Heart Valve Diseases - diagnostic imaging</topic><topic>Heart Valve Diseases - physiopathology</topic><topic>Heart Valves - diagnostic imaging</topic><topic>Heart Valves - drug effects</topic><topic>Heart Valves - physiopathology</topic><topic>Humans</topic><topic>Inhibiteurs spécifiques de la recapture de la sérotonine</topic><topic>Internal Medicine</topic><topic>Logistic Models</topic><topic>Maladies valvulaires induites par les médicaments</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Mitral Valve - drug effects</topic><topic>Mitral Valve Insufficiency - chemically induced</topic><topic>Multivariate Analysis</topic><topic>Observer Variation</topic><topic>Predictive Value of Tests</topic><topic>Prospective Studies</topic><topic>Referral and Consultation</topic><topic>Reproducibility of Results</topic><topic>Risk Assessment</topic><topic>Risk Factors</topic><topic>Selective serotonin reuptake inhibitor therapy</topic><topic>Serotonin Uptake Inhibitors - adverse effects</topic><topic>Time Factors</topic><topic>Tricuspid Valve - drug effects</topic><topic>Tricuspid Valve Insufficiency - chemically induced</topic><topic>Échocardiographie</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Maréchaux, Sylvestre</creatorcontrib><creatorcontrib>Jeu, Antoine</creatorcontrib><creatorcontrib>Jobic, Yannick</creatorcontrib><creatorcontrib>Ederhy, Stéphane</creatorcontrib><creatorcontrib>Donal, Erwan</creatorcontrib><creatorcontrib>Réant, Patricia</creatorcontrib><creatorcontrib>Abouth, Shirley</creatorcontrib><creatorcontrib>Arnasteen, Elise</creatorcontrib><creatorcontrib>Boulanger, Jacques</creatorcontrib><creatorcontrib>Ennezat, Pierre-Vladimir</creatorcontrib><creatorcontrib>Garban, Thierry</creatorcontrib><creatorcontrib>Szymanski, Catherine</creatorcontrib><creatorcontrib>Tribouilloy, Christophe</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect: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>MEDLINE - Academic</collection><jtitle>Archives of cardiovascular diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Maréchaux, Sylvestre</au><au>Jeu, Antoine</au><au>Jobic, Yannick</au><au>Ederhy, Stéphane</au><au>Donal, Erwan</au><au>Réant, Patricia</au><au>Abouth, Shirley</au><au>Arnasteen, Elise</au><au>Boulanger, Jacques</au><au>Ennezat, Pierre-Vladimir</au><au>Garban, Thierry</au><au>Szymanski, Catherine</au><au>Tribouilloy, Christophe</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Impact of selective serotonin reuptake inhibitor therapy on heart valves in patients exposed to benfluorex: A multicentre study</atitle><jtitle>Archives of cardiovascular diseases</jtitle><addtitle>Arch Cardiovasc Dis</addtitle><date>2013-06-01</date><risdate>2013</risdate><volume>106</volume><issue>6</issue><spage>349</spage><epage>356</epage><pages>349-356</pages><issn>1875-2136</issn><eissn>1875-2128</eissn><abstract>Summary Background Given the association between valvular heart disease and drugs that alter serotonin metabolism, concerns have been raised about the possibility of an association between selective serotonin reuptake inhibitor (SSRI) use and drug-induced valvular disease. In France, SSRI use has been suggested to be an important confounding factor in the development of heart valve lesions in patients exposed to benfluorex in the context of the ‘Médiator scandal’. Aims To address the relationship between SSRI use and valve regurgitation and morphology in a large cohort of patients exposed to benfluorex. Methods Overall, 832 consecutive patients exposed to benfluorex prospectively referred to 10 centres underwent complete echocardiography examinations according to a standardized protocol. Echocardiograms were independently and blindly read off-line by two experts. Results Ninety patients had been exposed to SSRIs for 3 months or more. The proportions of patients with no or trivial, mild, moderate or severe mitral regurgitation (MR) or aortic regurgitation (AR) were not different between SSRI patients and non-SSRI patients ( P = 0.63 and 0.58, respectively). The frequencies of AR ≥ mild (20 [22.2%] vs 145 [19.5%]; P = 0.55) and MR ≥ mild (14 [15.6%] vs 118 [15.9%]; P = 0.93) were similar in SSRI patients and non-SSRI patients. The frequencies of aortic and mitral valve abnormalities suggestive of drug-induced toxicity were also similar in the two patient groups. Multivariable logistic regression analysis confirmed the absence of any identifiable relationship between AR or MR and morphological abnormalities and SSRI use in the present cohort. Conclusion Exposure to SSRIs was not associated with an increased risk of heart valve regurgitation or morphological abnormalities suggestive of drug-induced toxicity in this large cohort of patients exposed to benfluorex.</abstract><cop>Netherlands</cop><pub>Elsevier Masson SAS</pub><pmid>23876809</pmid><doi>10.1016/j.acvd.2013.04.006</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record>
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subjects Adult
Aged
Aortic Valve - drug effects
Aortic Valve Insufficiency - chemically induced
Appetite Depressants - adverse effects
Benfluorex
Cardiovascular
Chi-Square Distribution
Drug-induced valvular disease
Echocardiography
Echocardiography, Doppler, Color
Female
Fenfluramine - adverse effects
Fenfluramine - analogs & derivatives
France
Heart Valve Diseases - chemically induced
Heart Valve Diseases - diagnostic imaging
Heart Valve Diseases - physiopathology
Heart Valves - diagnostic imaging
Heart Valves - drug effects
Heart Valves - physiopathology
Humans
Inhibiteurs spécifiques de la recapture de la sérotonine
Internal Medicine
Logistic Models
Maladies valvulaires induites par les médicaments
Male
Middle Aged
Mitral Valve - drug effects
Mitral Valve Insufficiency - chemically induced
Multivariate Analysis
Observer Variation
Predictive Value of Tests
Prospective Studies
Referral and Consultation
Reproducibility of Results
Risk Assessment
Risk Factors
Selective serotonin reuptake inhibitor therapy
Serotonin Uptake Inhibitors - adverse effects
Time Factors
Tricuspid Valve - drug effects
Tricuspid Valve Insufficiency - chemically induced
Échocardiographie
title Impact of selective serotonin reuptake inhibitor therapy on heart valves in patients exposed to benfluorex: A multicentre study
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