Nationwide registry-based analysis of cardiovascular risk factors and adverse outcomes in patients treated with strontium ranelate
Summary National registers showed that a large proportion of patients treated with strontium ranelate have conditions that may now contraindicate use. The risk of death in strontium ranelate-treated patients was significantly higher than that seen in users of other osteoporosis drugs even after adju...
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| Veröffentlicht in: | Osteoporosis international 2014-02, Vol.25 (2), p.757-762 |
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| creator | Abrahamsen, B. Grove, E. L. Vestergaard, P. |
| description | Summary
National registers showed that a large proportion of patients treated with strontium ranelate have conditions that may now contraindicate use. The risk of death in strontium ranelate-treated patients was significantly higher than that seen in users of other osteoporosis drugs even after adjusting for cardiovascular risk factor profile.
Introduction
The European Medicines Agency (EMA) recently warned that strontium ranelate should be avoided in patients with ischaemic heart disease (IHD), peripheral vascular disease (PVD) or cerebrovascular disease (CVD), and in patients with uncontrolled hypertension. We investigated to what extent patients beginning strontium ranelate had cardiovascular conditions and determined the rates of MI, stroke and death.
Methods
Using the Danish National Prescription Database, we identified all 3,252 patients aged 50+ who began strontium ranelate in 2005–2007 and 35,606 users of other osteoporosis drugs as controls. Hospital contacts and causes of death were retrieved from national registers.
Results
Patients starting strontium were older than patients treated with other osteoporosis drugs and more likely to suffer from IHD, PVD or CVD (combined prevalence 19.2 % in female users and 29.5 % in male users). The adjusted risk of MI was not significantly increased (women: HR 1.05 [95 % CI 0.79–1.41,
p
= 0.73]; men: 1.28 [0.74–2.20,
p
= 0.38]). For stroke, the adjusted HR was 1.23 (0.98–1.55,
p
= 0.07) in women and 1.64 (0.99–2.70,
p
= 0.05) in men. All-cause mortality was higher in strontium users (women: adjusted HR 1.20 [1.10–1.30,
p
|
| doi_str_mv | 10.1007/s00198-013-2469-4 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_1492445171</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3194707541</sourcerecordid><originalsourceid>FETCH-LOGICAL-c372t-a8d3121fce58d529afcdfd1e64239994a6dae67469d2ea2416a75c3d72fa4d453</originalsourceid><addsrcrecordid>eNp1kMtOHDEQRS2UCIbHB2SDLGXdiV_dHi8jlJeEwiZI7KzCrgaTmfbgcoNmmy_HaCDKhpVl1bm3VIexD1J8kkLYzySEdMtOSN0pM7jO7LGFNLr93NC_YwvhtO2ckVcH7JDoTrSMc3afHSijlTK2X7C_v6CmPD2miLzgTaJatt01EEYOE6y2lIjnkQcoMeUHoDCvoPCS6A8fIdRcqHGNjQ9YCHmea8hrJJ4mvmnNOFXitSDUVviY6i1vC_JU07zmBSZctcExez_CivDk5T1il9--_j770Z1ffP959uW8C9qq2sEyaqnkGLBfxl45GEMco8TBKO2cMzBEwME2D1EhKCMHsH3Q0aoRTDS9PmIfd72bku9npOrv8lzakeSlccqYXlrZKLmjQslEBUe_KWkNZeul8M_W_c66b9b9s3VvWub0pXm-XmP8l3jV3AC1A6iNphss_61-s_UJmw-QrQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1492445171</pqid></control><display><type>article</type><title>Nationwide registry-based analysis of cardiovascular risk factors and adverse outcomes in patients treated with strontium ranelate</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Abrahamsen, B. ; Grove, E. L. ; Vestergaard, P.</creator><creatorcontrib>Abrahamsen, B. ; Grove, E. L. ; Vestergaard, P.</creatorcontrib><description>Summary
National registers showed that a large proportion of patients treated with strontium ranelate have conditions that may now contraindicate use. The risk of death in strontium ranelate-treated patients was significantly higher than that seen in users of other osteoporosis drugs even after adjusting for cardiovascular risk factor profile.
Introduction
The European Medicines Agency (EMA) recently warned that strontium ranelate should be avoided in patients with ischaemic heart disease (IHD), peripheral vascular disease (PVD) or cerebrovascular disease (CVD), and in patients with uncontrolled hypertension. We investigated to what extent patients beginning strontium ranelate had cardiovascular conditions and determined the rates of MI, stroke and death.
Methods
Using the Danish National Prescription Database, we identified all 3,252 patients aged 50+ who began strontium ranelate in 2005–2007 and 35,606 users of other osteoporosis drugs as controls. Hospital contacts and causes of death were retrieved from national registers.
Results
Patients starting strontium were older than patients treated with other osteoporosis drugs and more likely to suffer from IHD, PVD or CVD (combined prevalence 19.2 % in female users and 29.5 % in male users). The adjusted risk of MI was not significantly increased (women: HR 1.05 [95 % CI 0.79–1.41,
p
= 0.73]; men: 1.28 [0.74–2.20,
p
= 0.38]). For stroke, the adjusted HR was 1.23 (0.98–1.55,
p
= 0.07) in women and 1.64 (0.99–2.70,
p
= 0.05) in men. All-cause mortality was higher in strontium users (women: adjusted HR 1.20 [1.10–1.30,
p
< 0.001]; men: adjusted HR 1.22 [1.03–1.45,
p
< 0.05]).
Conclusion
Patients treated with strontium ranelate have an unfavourable cardiovascular risk profile compared with users of other osteoporosis drugs. However, only the risk of death differed significantly from the rates observed in users of other osteoporosis drugs adjusted for risk factor profile. A large proportion of patients currently treated with strontium ranelate have conditions that would now be considered contraindications according to EMA.</description><identifier>ISSN: 0937-941X</identifier><identifier>EISSN: 1433-2965</identifier><identifier>DOI: 10.1007/s00198-013-2469-4</identifier><identifier>PMID: 24322475</identifier><language>eng</language><publisher>London: Springer London</publisher><subject>Aged ; Aged, 80 and over ; Bone Density Conservation Agents - adverse effects ; Bone Density Conservation Agents - therapeutic use ; Cardiovascular disease ; Cardiovascular Diseases - chemically induced ; Cardiovascular Diseases - mortality ; Cause of Death ; Databases, Factual ; Denmark - epidemiology ; Drug therapy ; Drug Utilization - statistics & numerical data ; Endocrinology ; Epidemiology ; Female ; Humans ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Mortality ; Orthopedics ; Osteoporosis ; Osteoporosis - drug therapy ; Osteoporosis - mortality ; Patient safety ; Registries ; Rheumatology ; Risk Factors ; Short Communication ; Thiophenes - adverse effects ; Thiophenes - therapeutic use ; Treatment Outcome</subject><ispartof>Osteoporosis international, 2014-02, Vol.25 (2), p.757-762</ispartof><rights>International Osteoporosis Foundation and National Osteoporosis Foundation 2013</rights><rights>International Osteoporosis Foundation and National Osteoporosis Foundation 2014</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c372t-a8d3121fce58d529afcdfd1e64239994a6dae67469d2ea2416a75c3d72fa4d453</citedby><cites>FETCH-LOGICAL-c372t-a8d3121fce58d529afcdfd1e64239994a6dae67469d2ea2416a75c3d72fa4d453</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00198-013-2469-4$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00198-013-2469-4$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24322475$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Abrahamsen, B.</creatorcontrib><creatorcontrib>Grove, E. L.</creatorcontrib><creatorcontrib>Vestergaard, P.</creatorcontrib><title>Nationwide registry-based analysis of cardiovascular risk factors and adverse outcomes in patients treated with strontium ranelate</title><title>Osteoporosis international</title><addtitle>Osteoporos Int</addtitle><addtitle>Osteoporos Int</addtitle><description>Summary
National registers showed that a large proportion of patients treated with strontium ranelate have conditions that may now contraindicate use. The risk of death in strontium ranelate-treated patients was significantly higher than that seen in users of other osteoporosis drugs even after adjusting for cardiovascular risk factor profile.
Introduction
The European Medicines Agency (EMA) recently warned that strontium ranelate should be avoided in patients with ischaemic heart disease (IHD), peripheral vascular disease (PVD) or cerebrovascular disease (CVD), and in patients with uncontrolled hypertension. We investigated to what extent patients beginning strontium ranelate had cardiovascular conditions and determined the rates of MI, stroke and death.
Methods
Using the Danish National Prescription Database, we identified all 3,252 patients aged 50+ who began strontium ranelate in 2005–2007 and 35,606 users of other osteoporosis drugs as controls. Hospital contacts and causes of death were retrieved from national registers.
Results
Patients starting strontium were older than patients treated with other osteoporosis drugs and more likely to suffer from IHD, PVD or CVD (combined prevalence 19.2 % in female users and 29.5 % in male users). The adjusted risk of MI was not significantly increased (women: HR 1.05 [95 % CI 0.79–1.41,
p
= 0.73]; men: 1.28 [0.74–2.20,
p
= 0.38]). For stroke, the adjusted HR was 1.23 (0.98–1.55,
p
= 0.07) in women and 1.64 (0.99–2.70,
p
= 0.05) in men. All-cause mortality was higher in strontium users (women: adjusted HR 1.20 [1.10–1.30,
p
< 0.001]; men: adjusted HR 1.22 [1.03–1.45,
p
< 0.05]).
Conclusion
Patients treated with strontium ranelate have an unfavourable cardiovascular risk profile compared with users of other osteoporosis drugs. However, only the risk of death differed significantly from the rates observed in users of other osteoporosis drugs adjusted for risk factor profile. A large proportion of patients currently treated with strontium ranelate have conditions that would now be considered contraindications according to EMA.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Bone Density Conservation Agents - adverse effects</subject><subject>Bone Density Conservation Agents - therapeutic use</subject><subject>Cardiovascular disease</subject><subject>Cardiovascular Diseases - chemically induced</subject><subject>Cardiovascular Diseases - mortality</subject><subject>Cause of Death</subject><subject>Databases, Factual</subject><subject>Denmark - epidemiology</subject><subject>Drug therapy</subject><subject>Drug Utilization - statistics & numerical data</subject><subject>Endocrinology</subject><subject>Epidemiology</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>Orthopedics</subject><subject>Osteoporosis</subject><subject>Osteoporosis - drug therapy</subject><subject>Osteoporosis - mortality</subject><subject>Patient safety</subject><subject>Registries</subject><subject>Rheumatology</subject><subject>Risk Factors</subject><subject>Short Communication</subject><subject>Thiophenes - adverse effects</subject><subject>Thiophenes - therapeutic use</subject><subject>Treatment Outcome</subject><issn>0937-941X</issn><issn>1433-2965</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kMtOHDEQRS2UCIbHB2SDLGXdiV_dHi8jlJeEwiZI7KzCrgaTmfbgcoNmmy_HaCDKhpVl1bm3VIexD1J8kkLYzySEdMtOSN0pM7jO7LGFNLr93NC_YwvhtO2ckVcH7JDoTrSMc3afHSijlTK2X7C_v6CmPD2miLzgTaJatt01EEYOE6y2lIjnkQcoMeUHoDCvoPCS6A8fIdRcqHGNjQ9YCHmea8hrJJ4mvmnNOFXitSDUVviY6i1vC_JU07zmBSZctcExez_CivDk5T1il9--_j770Z1ffP959uW8C9qq2sEyaqnkGLBfxl45GEMco8TBKO2cMzBEwME2D1EhKCMHsH3Q0aoRTDS9PmIfd72bku9npOrv8lzakeSlccqYXlrZKLmjQslEBUe_KWkNZeul8M_W_c66b9b9s3VvWub0pXm-XmP8l3jV3AC1A6iNphss_61-s_UJmw-QrQ</recordid><startdate>20140201</startdate><enddate>20140201</enddate><creator>Abrahamsen, B.</creator><creator>Grove, E. L.</creator><creator>Vestergaard, P.</creator><general>Springer London</general><general>Springer Nature B.V</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>3V.</scope><scope>7QP</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PHGZM</scope><scope>PHGZT</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope></search><sort><creationdate>20140201</creationdate><title>Nationwide registry-based analysis of cardiovascular risk factors and adverse outcomes in patients treated with strontium ranelate</title><author>Abrahamsen, B. ; Grove, E. L. ; Vestergaard, P.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c372t-a8d3121fce58d529afcdfd1e64239994a6dae67469d2ea2416a75c3d72fa4d453</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Bone Density Conservation Agents - adverse effects</topic><topic>Bone Density Conservation Agents - therapeutic use</topic><topic>Cardiovascular disease</topic><topic>Cardiovascular Diseases - chemically induced</topic><topic>Cardiovascular Diseases - mortality</topic><topic>Cause of Death</topic><topic>Databases, Factual</topic><topic>Denmark - epidemiology</topic><topic>Drug therapy</topic><topic>Drug Utilization - statistics & numerical data</topic><topic>Endocrinology</topic><topic>Epidemiology</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Mortality</topic><topic>Orthopedics</topic><topic>Osteoporosis</topic><topic>Osteoporosis - drug therapy</topic><topic>Osteoporosis - mortality</topic><topic>Patient safety</topic><topic>Registries</topic><topic>Rheumatology</topic><topic>Risk Factors</topic><topic>Short Communication</topic><topic>Thiophenes - adverse effects</topic><topic>Thiophenes - therapeutic use</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Abrahamsen, B.</creatorcontrib><creatorcontrib>Grove, E. L.</creatorcontrib><creatorcontrib>Vestergaard, P.</creatorcontrib><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>Calcium & Calcified Tissue Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Physical Education Index</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>Public Health 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 UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest Central (New)</collection><collection>ProQuest One Academic (New)</collection><collection>ProQuest Health & Medical Research Collection</collection><collection>ProQuest One Academic Middle East (New)</collection><collection>ProQuest One Health & Nursing</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><jtitle>Osteoporosis international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Abrahamsen, B.</au><au>Grove, E. L.</au><au>Vestergaard, P.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Nationwide registry-based analysis of cardiovascular risk factors and adverse outcomes in patients treated with strontium ranelate</atitle><jtitle>Osteoporosis international</jtitle><stitle>Osteoporos Int</stitle><addtitle>Osteoporos Int</addtitle><date>2014-02-01</date><risdate>2014</risdate><volume>25</volume><issue>2</issue><spage>757</spage><epage>762</epage><pages>757-762</pages><issn>0937-941X</issn><eissn>1433-2965</eissn><abstract>Summary
National registers showed that a large proportion of patients treated with strontium ranelate have conditions that may now contraindicate use. The risk of death in strontium ranelate-treated patients was significantly higher than that seen in users of other osteoporosis drugs even after adjusting for cardiovascular risk factor profile.
Introduction
The European Medicines Agency (EMA) recently warned that strontium ranelate should be avoided in patients with ischaemic heart disease (IHD), peripheral vascular disease (PVD) or cerebrovascular disease (CVD), and in patients with uncontrolled hypertension. We investigated to what extent patients beginning strontium ranelate had cardiovascular conditions and determined the rates of MI, stroke and death.
Methods
Using the Danish National Prescription Database, we identified all 3,252 patients aged 50+ who began strontium ranelate in 2005–2007 and 35,606 users of other osteoporosis drugs as controls. Hospital contacts and causes of death were retrieved from national registers.
Results
Patients starting strontium were older than patients treated with other osteoporosis drugs and more likely to suffer from IHD, PVD or CVD (combined prevalence 19.2 % in female users and 29.5 % in male users). The adjusted risk of MI was not significantly increased (women: HR 1.05 [95 % CI 0.79–1.41,
p
= 0.73]; men: 1.28 [0.74–2.20,
p
= 0.38]). For stroke, the adjusted HR was 1.23 (0.98–1.55,
p
= 0.07) in women and 1.64 (0.99–2.70,
p
= 0.05) in men. All-cause mortality was higher in strontium users (women: adjusted HR 1.20 [1.10–1.30,
p
< 0.001]; men: adjusted HR 1.22 [1.03–1.45,
p
< 0.05]).
Conclusion
Patients treated with strontium ranelate have an unfavourable cardiovascular risk profile compared with users of other osteoporosis drugs. However, only the risk of death differed significantly from the rates observed in users of other osteoporosis drugs adjusted for risk factor profile. A large proportion of patients currently treated with strontium ranelate have conditions that would now be considered contraindications according to EMA.</abstract><cop>London</cop><pub>Springer London</pub><pmid>24322475</pmid><doi>10.1007/s00198-013-2469-4</doi><tpages>6</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0937-941X |
| ispartof | Osteoporosis international, 2014-02, Vol.25 (2), p.757-762 |
| issn | 0937-941X 1433-2965 |
| language | eng |
| recordid | cdi_proquest_journals_1492445171 |
| source | MEDLINE; SpringerLink Journals - AutoHoldings |
| subjects | Aged Aged, 80 and over Bone Density Conservation Agents - adverse effects Bone Density Conservation Agents - therapeutic use Cardiovascular disease Cardiovascular Diseases - chemically induced Cardiovascular Diseases - mortality Cause of Death Databases, Factual Denmark - epidemiology Drug therapy Drug Utilization - statistics & numerical data Endocrinology Epidemiology Female Humans Male Medicine Medicine & Public Health Middle Aged Mortality Orthopedics Osteoporosis Osteoporosis - drug therapy Osteoporosis - mortality Patient safety Registries Rheumatology Risk Factors Short Communication Thiophenes - adverse effects Thiophenes - therapeutic use Treatment Outcome |
| title | Nationwide registry-based analysis of cardiovascular risk factors and adverse outcomes in patients treated with strontium ranelate |
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