Treatment with dabigatran or warfarin in patients with venous thromboembolism and cancer
Summary The efficacy and safety of dabigatran for treatment of venous thromboembolism (VTE) were demonstrated in two trials. It is unclear if the results pertain to patients with cancer and VTE. Data from two randomised trials comparing dabigatran and warfarin for acute VTE were pooled. Primary effi...
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| Veröffentlicht in: | Thrombosis and haemostasis 2015-07, Vol.113 (1), p.150-157 |
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| creator | Schulman, Sam Goldhaber, Samuel Z. Kearon, Clive Kakkar, Ajay K. Schellong, Sebastian Eriksson, Henry Hantel, Stefan Feuring, Martin Kreuzer, Jörg |
| description | Summary
The efficacy and safety of dabigatran for treatment of venous thromboembolism (VTE) were demonstrated in two trials. It is unclear if the results pertain to patients with cancer and VTE. Data from two randomised trials comparing dabigatran and warfarin for acute VTE were pooled. Primary efficacy outcome was symptomatic recurrent VTE and related death from randomisation to the end of the treatment period. Safety outcomes were major, major and clinically relevant non-major, and any bleeding during the oral-only treatment period. Patients with active cancer (=within 5 years) at baseline or diagnosed during the study were analysed. Compared with 4,772 patients without cancer, recurrent VTE occurred more frequently in 335 patients with cancer at any time (hazard ratio [HR] 3.3; 95 % confidence interval [CI], 2.1–5.3) and more often in 114 with cancer diagnosed during the study compared to 221 with cancer at baseline (HR 2.6; 95 % CI, 1.1–6.2). There was no significant difference in efficacy between dabigatran and warfarin for cancer at baseline (HR 0.75; 95 % CI, 0.20–2.8) or diagnosed during the study (HR 0.63; 95 % CI, 0.20–2.0). Major bleeding (HR 4.1; 95 % CI, 2.2–7.5) and any bleeding (HR 1.5; 95 % CI, 1.2–2.0) were more frequent in patients with cancer than without, but with similar incidence in cancer with dabigatran or warfarin. In conclusion, in cancer patients, dabigatran provided similar clinical benefit as warfarin. VTE recurrence or bleeding were similar in patients on dabigatran or warfarin. The efficacy of dabigatran has not been assessed in comparison with low-molecular-weight heparin. |
| doi_str_mv | 10.1160/TH14-11-0977 |
| format | Article |
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The efficacy and safety of dabigatran for treatment of venous thromboembolism (VTE) were demonstrated in two trials. It is unclear if the results pertain to patients with cancer and VTE. Data from two randomised trials comparing dabigatran and warfarin for acute VTE were pooled. Primary efficacy outcome was symptomatic recurrent VTE and related death from randomisation to the end of the treatment period. Safety outcomes were major, major and clinically relevant non-major, and any bleeding during the oral-only treatment period. Patients with active cancer (=within 5 years) at baseline or diagnosed during the study were analysed. Compared with 4,772 patients without cancer, recurrent VTE occurred more frequently in 335 patients with cancer at any time (hazard ratio [HR] 3.3; 95 % confidence interval [CI], 2.1–5.3) and more often in 114 with cancer diagnosed during the study compared to 221 with cancer at baseline (HR 2.6; 95 % CI, 1.1–6.2). There was no significant difference in efficacy between dabigatran and warfarin for cancer at baseline (HR 0.75; 95 % CI, 0.20–2.8) or diagnosed during the study (HR 0.63; 95 % CI, 0.20–2.0). Major bleeding (HR 4.1; 95 % CI, 2.2–7.5) and any bleeding (HR 1.5; 95 % CI, 1.2–2.0) were more frequent in patients with cancer than without, but with similar incidence in cancer with dabigatran or warfarin. In conclusion, in cancer patients, dabigatran provided similar clinical benefit as warfarin. VTE recurrence or bleeding were similar in patients on dabigatran or warfarin. The efficacy of dabigatran has not been assessed in comparison with low-molecular-weight heparin.</description><identifier>ISSN: 0340-6245</identifier><identifier>EISSN: 2567-689X</identifier><identifier>DOI: 10.1160/TH14-11-0977</identifier><identifier>PMID: 25739680</identifier><language>eng</language><publisher>Germany: Schattauer GmbH</publisher><subject>Adult ; Aged ; Anticoagulants - adverse effects ; Anticoagulants - therapeutic use ; Antithrombins - adverse effects ; Antithrombins - therapeutic use ; Dabigatran - adverse effects ; Dabigatran - therapeutic use ; Hemorrhage - chemically induced ; Humans ; Male ; Middle Aged ; Neoplasms - blood ; Neoplasms - complications ; Neoplasms - mortality ; New Technologies, Diagnostic Tools and Drugs ; Odds Ratio ; Proportional Hazards Models ; Randomized Controlled Trials as Topic ; Recurrence ; Risk Assessment ; Risk Factors ; Time Factors ; Treatment Outcome ; Venous Thromboembolism - blood ; Venous Thromboembolism - diagnosis ; Venous Thromboembolism - drug therapy ; Venous Thromboembolism - etiology ; Venous Thromboembolism - mortality ; Warfarin - adverse effects ; Warfarin - therapeutic use</subject><ispartof>Thrombosis and haemostasis, 2015-07, Vol.113 (1), p.150-157</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c327t-eafb27df691bf9eb57724d039a0f09fbe2acddf4d28fd5a3fd213f086fbe6a223</citedby><cites>FETCH-LOGICAL-c327t-eafb27df691bf9eb57724d039a0f09fbe2acddf4d28fd5a3fd213f086fbe6a223</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.thieme-connect.de/products/ejournals/pdf/10.1160/TH14-11-0977.pdf$$EPDF$$P50$$Gthieme$$H</linktopdf><linktohtml>$$Uhttps://www.thieme-connect.de/products/ejournals/html/10.1160/TH14-11-0977$$EHTML$$P50$$Gthieme$$H</linktohtml><link.rule.ids>314,777,781,3005,27905,27906,54540,54541</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25739680$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Schulman, Sam</creatorcontrib><creatorcontrib>Goldhaber, Samuel Z.</creatorcontrib><creatorcontrib>Kearon, Clive</creatorcontrib><creatorcontrib>Kakkar, Ajay K.</creatorcontrib><creatorcontrib>Schellong, Sebastian</creatorcontrib><creatorcontrib>Eriksson, Henry</creatorcontrib><creatorcontrib>Hantel, Stefan</creatorcontrib><creatorcontrib>Feuring, Martin</creatorcontrib><creatorcontrib>Kreuzer, Jörg</creatorcontrib><title>Treatment with dabigatran or warfarin in patients with venous thromboembolism and cancer</title><title>Thrombosis and haemostasis</title><addtitle>Thromb Haemost</addtitle><description>Summary
The efficacy and safety of dabigatran for treatment of venous thromboembolism (VTE) were demonstrated in two trials. It is unclear if the results pertain to patients with cancer and VTE. Data from two randomised trials comparing dabigatran and warfarin for acute VTE were pooled. Primary efficacy outcome was symptomatic recurrent VTE and related death from randomisation to the end of the treatment period. Safety outcomes were major, major and clinically relevant non-major, and any bleeding during the oral-only treatment period. Patients with active cancer (=within 5 years) at baseline or diagnosed during the study were analysed. Compared with 4,772 patients without cancer, recurrent VTE occurred more frequently in 335 patients with cancer at any time (hazard ratio [HR] 3.3; 95 % confidence interval [CI], 2.1–5.3) and more often in 114 with cancer diagnosed during the study compared to 221 with cancer at baseline (HR 2.6; 95 % CI, 1.1–6.2). There was no significant difference in efficacy between dabigatran and warfarin for cancer at baseline (HR 0.75; 95 % CI, 0.20–2.8) or diagnosed during the study (HR 0.63; 95 % CI, 0.20–2.0). Major bleeding (HR 4.1; 95 % CI, 2.2–7.5) and any bleeding (HR 1.5; 95 % CI, 1.2–2.0) were more frequent in patients with cancer than without, but with similar incidence in cancer with dabigatran or warfarin. In conclusion, in cancer patients, dabigatran provided similar clinical benefit as warfarin. VTE recurrence or bleeding were similar in patients on dabigatran or warfarin. The efficacy of dabigatran has not been assessed in comparison with low-molecular-weight heparin.</description><subject>Adult</subject><subject>Aged</subject><subject>Anticoagulants - adverse effects</subject><subject>Anticoagulants - therapeutic use</subject><subject>Antithrombins - adverse effects</subject><subject>Antithrombins - therapeutic use</subject><subject>Dabigatran - adverse effects</subject><subject>Dabigatran - therapeutic use</subject><subject>Hemorrhage - chemically induced</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neoplasms - blood</subject><subject>Neoplasms - complications</subject><subject>Neoplasms - mortality</subject><subject>New Technologies, Diagnostic Tools and Drugs</subject><subject>Odds Ratio</subject><subject>Proportional Hazards Models</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Recurrence</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Venous Thromboembolism - blood</subject><subject>Venous Thromboembolism - diagnosis</subject><subject>Venous Thromboembolism - drug therapy</subject><subject>Venous Thromboembolism - etiology</subject><subject>Venous Thromboembolism - mortality</subject><subject>Warfarin - adverse effects</subject><subject>Warfarin - therapeutic use</subject><issn>0340-6245</issn><issn>2567-689X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNptkE1LAzEQhoModq3ePEvuupqP3WRzlKJWKHip0Nsyu0nslm62JKnFf2_KqidhhhmYhxfmQeiakntKBXlYzmmRU5oTJeUJylgpZC4qtTpFGeEFyQUrygm6CGFDCBWFKs_RhJWSK1GRDK2W3kDsjYv40MU11tB0HxA9ODx4fABvwXcOp9pB7BIWRu7TuGEfcFz7oW8Gk3rbhR6D07gF1xp_ic4sbIO5-plT9P78tJzN88Xby-vscZG3nMmYG7ANk9oKRRurTFNKyQpNuAJiibKNYdBqbQvNKqtL4FYzyi2pRDoJYIxP0d2Y2_ohBG9svfNdD_6rpqQ-CqqPgtJWHwUl_GbEd_umN_oP_jWSgNsRiOvO9KbeDHvv0gP_x30DjYRxLQ</recordid><startdate>20150701</startdate><enddate>20150701</enddate><creator>Schulman, Sam</creator><creator>Goldhaber, Samuel Z.</creator><creator>Kearon, Clive</creator><creator>Kakkar, Ajay K.</creator><creator>Schellong, Sebastian</creator><creator>Eriksson, Henry</creator><creator>Hantel, Stefan</creator><creator>Feuring, Martin</creator><creator>Kreuzer, Jörg</creator><general>Schattauer GmbH</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></search><sort><creationdate>20150701</creationdate><title>Treatment with dabigatran or warfarin in patients with venous thromboembolism and cancer</title><author>Schulman, Sam ; Goldhaber, Samuel Z. ; Kearon, Clive ; Kakkar, Ajay K. ; Schellong, Sebastian ; Eriksson, Henry ; Hantel, Stefan ; Feuring, Martin ; Kreuzer, Jörg</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c327t-eafb27df691bf9eb57724d039a0f09fbe2acddf4d28fd5a3fd213f086fbe6a223</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Anticoagulants - adverse effects</topic><topic>Anticoagulants - therapeutic use</topic><topic>Antithrombins - adverse effects</topic><topic>Antithrombins - therapeutic use</topic><topic>Dabigatran - adverse effects</topic><topic>Dabigatran - therapeutic use</topic><topic>Hemorrhage - chemically induced</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Neoplasms - blood</topic><topic>Neoplasms - complications</topic><topic>Neoplasms - mortality</topic><topic>New Technologies, Diagnostic Tools and Drugs</topic><topic>Odds Ratio</topic><topic>Proportional Hazards Models</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Recurrence</topic><topic>Risk Assessment</topic><topic>Risk Factors</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Venous Thromboembolism - blood</topic><topic>Venous Thromboembolism - diagnosis</topic><topic>Venous Thromboembolism - drug therapy</topic><topic>Venous Thromboembolism - etiology</topic><topic>Venous Thromboembolism - mortality</topic><topic>Warfarin - adverse effects</topic><topic>Warfarin - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Schulman, Sam</creatorcontrib><creatorcontrib>Goldhaber, Samuel Z.</creatorcontrib><creatorcontrib>Kearon, Clive</creatorcontrib><creatorcontrib>Kakkar, Ajay K.</creatorcontrib><creatorcontrib>Schellong, Sebastian</creatorcontrib><creatorcontrib>Eriksson, Henry</creatorcontrib><creatorcontrib>Hantel, Stefan</creatorcontrib><creatorcontrib>Feuring, Martin</creatorcontrib><creatorcontrib>Kreuzer, Jörg</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Thrombosis and haemostasis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Schulman, Sam</au><au>Goldhaber, Samuel Z.</au><au>Kearon, Clive</au><au>Kakkar, Ajay K.</au><au>Schellong, Sebastian</au><au>Eriksson, Henry</au><au>Hantel, Stefan</au><au>Feuring, Martin</au><au>Kreuzer, Jörg</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Treatment with dabigatran or warfarin in patients with venous thromboembolism and cancer</atitle><jtitle>Thrombosis and haemostasis</jtitle><addtitle>Thromb Haemost</addtitle><date>2015-07-01</date><risdate>2015</risdate><volume>113</volume><issue>1</issue><spage>150</spage><epage>157</epage><pages>150-157</pages><issn>0340-6245</issn><eissn>2567-689X</eissn><abstract>Summary
The efficacy and safety of dabigatran for treatment of venous thromboembolism (VTE) were demonstrated in two trials. It is unclear if the results pertain to patients with cancer and VTE. Data from two randomised trials comparing dabigatran and warfarin for acute VTE were pooled. Primary efficacy outcome was symptomatic recurrent VTE and related death from randomisation to the end of the treatment period. Safety outcomes were major, major and clinically relevant non-major, and any bleeding during the oral-only treatment period. Patients with active cancer (=within 5 years) at baseline or diagnosed during the study were analysed. Compared with 4,772 patients without cancer, recurrent VTE occurred more frequently in 335 patients with cancer at any time (hazard ratio [HR] 3.3; 95 % confidence interval [CI], 2.1–5.3) and more often in 114 with cancer diagnosed during the study compared to 221 with cancer at baseline (HR 2.6; 95 % CI, 1.1–6.2). There was no significant difference in efficacy between dabigatran and warfarin for cancer at baseline (HR 0.75; 95 % CI, 0.20–2.8) or diagnosed during the study (HR 0.63; 95 % CI, 0.20–2.0). Major bleeding (HR 4.1; 95 % CI, 2.2–7.5) and any bleeding (HR 1.5; 95 % CI, 1.2–2.0) were more frequent in patients with cancer than without, but with similar incidence in cancer with dabigatran or warfarin. In conclusion, in cancer patients, dabigatran provided similar clinical benefit as warfarin. VTE recurrence or bleeding were similar in patients on dabigatran or warfarin. The efficacy of dabigatran has not been assessed in comparison with low-molecular-weight heparin.</abstract><cop>Germany</cop><pub>Schattauer GmbH</pub><pmid>25739680</pmid><doi>10.1160/TH14-11-0977</doi><tpages>8</tpages></addata></record> |
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| ispartof | Thrombosis and haemostasis, 2015-07, Vol.113 (1), p.150-157 |
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| source | MEDLINE; Thieme Connect Journals |
| subjects | Adult Aged Anticoagulants - adverse effects Anticoagulants - therapeutic use Antithrombins - adverse effects Antithrombins - therapeutic use Dabigatran - adverse effects Dabigatran - therapeutic use Hemorrhage - chemically induced Humans Male Middle Aged Neoplasms - blood Neoplasms - complications Neoplasms - mortality New Technologies, Diagnostic Tools and Drugs Odds Ratio Proportional Hazards Models Randomized Controlled Trials as Topic Recurrence Risk Assessment Risk Factors Time Factors Treatment Outcome Venous Thromboembolism - blood Venous Thromboembolism - diagnosis Venous Thromboembolism - drug therapy Venous Thromboembolism - etiology Venous Thromboembolism - mortality Warfarin - adverse effects Warfarin - therapeutic use |
| title | Treatment with dabigatran or warfarin in patients with venous thromboembolism and cancer |
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