Effect of Statins on Venous Thromboembolic Events: A Meta-analysis of Published and Unpublished Evidence from Randomised Controlled Trials
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{"title"=>"Effect of Statins on Venous Thromboembolic Events: A Meta-analysis of Published and Unpublished Evidence from Randomised Controlled Trials", "type"=>"journal", "authors"=>[{"first_name"=>"Kazem", "last_name"=>"Rahimi", "scopus_author_id"=>"57195398531"}, {"first_name"=>"Neeraj", "last_name"=>"Bhala", "scopus_author_id"=>"15759186000"}, {"first_name"=>"Pieter", "last_name"=>"Kamphuisen", "scopus_author_id"=>"56985680100"}, {"first_name"=>"Jonathan", "last_name"=>"Emberson", "scopus_author_id"=>"6701688192"}, {"first_name"=>"Sara", "last_name"=>"Biere-Rafi", "scopus_author_id"=>"36105142500"}, {"first_name"=>"Vera", "last_name"=>"Krane", "scopus_author_id"=>"6602099201"}, {"first_name"=>"Michele", "last_name"=>"Robertson", "scopus_author_id"=>"56701792700"}, {"first_name"=>"John", "last_name"=>"Wikstrand", "scopus_author_id"=>"7005709773"}, {"first_name"=>"John", "last_name"=>"McMurray", "scopus_author_id"=>"7202558724"}], "year"=>2012, "source"=>"PLoS Medicine", "identifiers"=>{"issn"=>"15491277", "scopus"=>"2-s2.0-84866678038", "sgr"=>"84866678038", "pui"=>"365720714", "isbn"=>"1549-1676 (Electronic)\\r1549-1277 (Linking)", "pmid"=>"23028261", "doi"=>"10.1371/journal.pmed.1001310"}, "id"=>"892ab14e-fed7-3895-b50e-ece6c6a971b1", "abstract"=>"BACKGROUND: It has been suggested that statins substantially reduce the risk of venous thromboembolic events. We sought to test this hypothesis by performing a meta-analysis of both published and unpublished results from randomised trials of statins.\\n\\nMETHODS AND FINDINGS: We searched MEDLINE, EMBASE, and Cochrane CENTRAL up to March 2012 for randomised controlled trials comparing statin with no statin, or comparing high dose versus standard dose statin, with 100 or more randomised participants and at least 6 months' follow-up. Investigators were contacted for unpublished information about venous thromboembolic events during follow-up. Twenty-two trials of statin versus control (105,759 participants) and seven trials of an intensive versus a standard dose statin regimen (40,594 participants) were included. In trials of statin versus control, allocation to statin therapy did not significantly reduce the risk of venous thromboembolic events (465 [0.9%] statin versus 521 [1.0%] control, odds ratio [OR] = 0.89, 95% CI 0.78-1.01, p = 0.08) with no evidence of heterogeneity between effects on deep vein thrombosis (266 versus 311, OR 0.85, 95% CI 0.72-1.01) and effects on pulmonary embolism (205 versus 222, OR 0.92, 95% CI 0.76-1.12). Exclusion of the trial result that provided the motivation for our meta-analysis (JUPITER) had little impact on the findings for venous thromboembolic events (431 [0.9%] versus 461 [1.0%], OR = 0.93 [95% CI 0.82-1.07], p = 0.32 among the other 21 trials). There was no evidence that higher dose statin therapy reduced the risk of venous thromboembolic events compared with standard dose statin therapy (198 [1.0%] versus 202 [1.0%], OR = 0.98, 95% CI 0.80-1.20, p = 0.87). Risk of bias overall was small but a certain degree of effect underestimation due to random error cannot be ruled out. Please see later in the article for the Editors' Summary.\\n\\nCONCLUSIONS: The findings from this meta-analysis do not support the previous suggestion of a large protective effect of statins (or higher dose statins) on venous thromboembolic events. However, a more moderate reduction in risk up to about one-fifth cannot be ruled out.", "link"=>"http://www.mendeley.com/research/effect-statins-venous-thromboembolic-events-metaanalysis-published-unpublished-evidence-randomised-c", "reader_count"=>32, "reader_count_by_academic_status"=>{"Professor > Associate Professor"=>2, "Researcher"=>5, "Student > Doctoral Student"=>2, "Student > Ph. D. Student"=>6, "Student > Postgraduate"=>4, "Other"=>5, "Student > Master"=>2, "Student > Bachelor"=>2, "Lecturer"=>1, "Professor"=>3}, "reader_count_by_user_role"=>{"Professor > Associate Professor"=>2, "Researcher"=>5, "Student > Doctoral Student"=>2, "Student > Ph. D. Student"=>6, "Student > Postgraduate"=>4, "Other"=>5, "Student > Master"=>2, "Student > Bachelor"=>2, "Lecturer"=>1, "Professor"=>3}, "reader_count_by_subject_area"=>{"Unspecified"=>2, "Biochemistry, Genetics and Molecular Biology"=>1, "Medicine and Dentistry"=>26, "Agricultural and Biological Sciences"=>2, "Business, Management and Accounting"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>26}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>2}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Unspecified"=>{"Unspecified"=>2}}, "reader_count_by_country"=>{"Canada"=>1, "Netherlands"=>1, "France"=>2, "Germany"=>2}, "group_count"=>1}

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/575087"], "description"=>"<p>Selection bias is based on random sequence generation and allocation concealment; performance bias includes blinding of participants and study investigators for the outcomes of interest; detection bias includes blinding of outcome assessors; attrition bias indicates systematic loss of participants in one arm, which could lead to missing outcome data for that trial arm over the other trial arm; and reporting bias includes the possibility of selective outcome reporting. Selection bias is a feature of the trial design. Performance and detection bias are overall low given that most data were collected without any prior knowledge of the investigators of the tested hypothesis in this study at the time of event collection. All analysis in this report are based on intention-to-treat and we further mitigated the possible effect of any attrition bias and reporting bias at individual trial level by collection of additional unpublished data.</p><p>PE, pulmonary embolism; VTE, venous thromboembolic event.</p>", "links"=>[], "tags"=>["cardiovascular", "Venous thromboembolism", "Clinical research design", "meta-analyses", "venous", "thromboembolic"], "article_id"=>245568, "categories"=>["Medicine"], "users"=>["Kazem Rahimi", "Neeraj Bhala", "Pieter Kamphuisen", "Jonathan Emberson", "Sara Biere-Rafi", "Vera Krane", "Michele Robertson", "John Wikstrand", "John McMurray"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001310.t002", "stats"=>{"downloads"=>1, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Outcome_determination_and_risk_of_bias_for_venous_thromboembolic_events_/245568", "title"=>"Outcome determination and risk of bias for venous thromboembolic events.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-09-18 01:32:48"}
  • {"files"=>["https://ndownloader.figshare.com/files/574642"], "description"=>"<p>Effect of more intensive versus standard statin therapy on venous thromboembolism.</p>", "links"=>[], "tags"=>["cardiovascular", "Venous thromboembolism", "Clinical research design", "meta-analyses", "intensive", "statin", "venous"], "article_id"=>245124, "categories"=>["Medicine"], "users"=>["Kazem Rahimi", "Neeraj Bhala", "Pieter Kamphuisen", "Jonathan Emberson", "Sara Biere-Rafi", "Vera Krane", "Michele Robertson", "John Wikstrand", "John McMurray"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001310.g003", "stats"=>{"downloads"=>2, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Effect_of_more_intensive_versus_standard_statin_therapy_on_venous_thromboembolism_/245124", "title"=>"Effect of more intensive versus standard statin therapy on venous thromboembolism.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-09-18 01:25:24"}
  • {"files"=>["https://ndownloader.figshare.com/files/574904"], "description"=>"<p>Effect of statin therapy on venous thromboembolism in primary cardiovascular prevention trials compared with other trials.</p>", "links"=>[], "tags"=>["cardiovascular", "Venous thromboembolism", "Clinical research design", "meta-analyses", "statin", "venous", "thromboembolism", "trials", "compared"], "article_id"=>245383, "categories"=>["Medicine"], "users"=>["Kazem Rahimi", "Neeraj Bhala", "Pieter Kamphuisen", "Jonathan Emberson", "Sara Biere-Rafi", "Vera Krane", "Michele Robertson", "John Wikstrand", "John McMurray"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001310.g005", "stats"=>{"downloads"=>4, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Effect_of_statin_therapy_on_venous_thromboembolism_in_primary_cardiovascular_prevention_trials_compared_with_other_trials_/245383", "title"=>"Effect of statin therapy on venous thromboembolism in primary cardiovascular prevention trials compared with other trials.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-09-18 01:29:43"}
  • {"files"=>["https://ndownloader.figshare.com/files/302842", "https://ndownloader.figshare.com/files/302858", "https://ndownloader.figshare.com/files/302874", "https://ndownloader.figshare.com/files/302886", "https://ndownloader.figshare.com/files/302902"], "description"=>"<div><h3>Background</h3><p>It has been suggested that statins substantially reduce the risk of venous thromboembolic events. We sought to test this hypothesis by performing a meta-analysis of both published and unpublished results from randomised trials of statins.</p> <h3>Methods and Findings</h3><p>We searched MEDLINE, EMBASE, and Cochrane CENTRAL up to March 2012 for randomised controlled trials comparing statin with no statin, or comparing high dose versus standard dose statin, with 100 or more randomised participants and at least 6 months' follow-up. Investigators were contacted for unpublished information about venous thromboembolic events during follow-up. Twenty-two trials of statin versus control (105,759 participants) and seven trials of an intensive versus a standard dose statin regimen (40,594 participants) were included. In trials of statin versus control, allocation to statin therapy did not significantly reduce the risk of venous thromboembolic events (465 [0.9%] statin versus 521 [1.0%] control, odds ratio [OR] = 0.89, 95% CI 0.78–1.01, <em>p</em> = 0.08) with no evidence of heterogeneity between effects on deep vein thrombosis (266 versus 311, OR 0.85, 95% CI 0.72–1.01) and effects on pulmonary embolism (205 versus 222, OR 0.92, 95% CI 0.76–1.12). Exclusion of the trial result that provided the motivation for our meta-analysis (JUPITER) had little impact on the findings for venous thromboembolic events (431 [0.9%] versus 461 [1.0%], OR = 0.93 [95% CI 0.82–1.07], <em>p</em> = 0.32 among the other 21 trials). There was no evidence that higher dose statin therapy reduced the risk of venous thromboembolic events compared with standard dose statin therapy (198 [1.0%] versus 202 [1.0%], OR = 0.98, 95% CI 0.80–1.20, <em>p</em> = 0.87). Risk of bias overall was small but a certain degree of effect underestimation due to random error cannot be ruled out.</p> <p> <em>Please see later in the article for the Editors' Summary.</em></p> <h3>Conclusions</h3><p>The findings from this meta-analysis do not support the previous suggestion of a large protective effect of statins (or higher dose statins) on venous thromboembolic events. However, a more moderate reduction in risk up to about one-fifth cannot be ruled out.</p> </div>", "links"=>[], "tags"=>["cardiovascular", "Venous thromboembolism", "Clinical research design", "meta-analyses", "statins", "venous", "thromboembolic", "meta-analysis", "published", "unpublished", "randomised", "controlled", "trials"], "article_id"=>119721, "categories"=>["Medicine"], "users"=>["Kazem Rahimi", "Neeraj Bhala", "Pieter Kamphuisen", "Jonathan Emberson", "Sara Biere-Rafi", "Vera Krane", "Michele Robertson", "John Wikstrand", "John McMurray"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001310.s001", "https://dx.doi.org/10.1371/journal.pmed.1001310.s002", "https://dx.doi.org/10.1371/journal.pmed.1001310.s003", "https://dx.doi.org/10.1371/journal.pmed.1001310.s004", "https://dx.doi.org/10.1371/journal.pmed.1001310.s005"], "stats"=>{"downloads"=>10, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Effect_of_Statins_on_Venous_Thromboembolic_Events_A_Meta_analysis_of_Published_and_Unpublished_Evidence_from_Randomised_Controlled_Trials/119721", "title"=>"Effect of Statins on Venous Thromboembolic Events: A Meta-analysis of Published and Unpublished Evidence from Randomised Controlled Trials", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2012-09-18 02:42:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/574461"], "description"=>"<p>Effect of statin therapy on venous thromboembolism.</p>", "links"=>[], "tags"=>["cardiovascular", "Venous thromboembolism", "Clinical research design", "meta-analyses", "statin", "venous"], "article_id"=>244939, "categories"=>["Medicine"], "users"=>["Kazem Rahimi", "Neeraj Bhala", "Pieter Kamphuisen", "Jonathan Emberson", "Sara Biere-Rafi", "Vera Krane", "Michele Robertson", "John Wikstrand", "John McMurray"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001310.g002", "stats"=>{"downloads"=>1, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Effect_of_statin_therapy_on_venous_thromboembolism_/244939", "title"=>"Effect of statin therapy on venous thromboembolism.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-09-18 01:22:19"}
  • {"files"=>["https://ndownloader.figshare.com/files/574297"], "description"=>"<p>Flow-diagram of search retrieval process.</p>", "links"=>[], "tags"=>["cardiovascular", "Venous thromboembolism", "Clinical research design", "meta-analyses", "retrieval"], "article_id"=>244782, "categories"=>["Medicine"], "users"=>["Kazem Rahimi", "Neeraj Bhala", "Pieter Kamphuisen", "Jonathan Emberson", "Sara Biere-Rafi", "Vera Krane", "Michele Robertson", "John Wikstrand", "John McMurray"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001310.g001", "stats"=>{"downloads"=>1, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Flow_diagram_of_search_retrieval_process_/244782", "title"=>"Flow-diagram of search retrieval process.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-09-18 01:19:42"}
  • {"files"=>["https://ndownloader.figshare.com/files/575039"], "description"=>"a<p>LDL-cholesterol differences are based on average differences between the two groups at 1 y (or the closest time to 1 y if 1 y data unavailable).</p><p>A, atorvastatin; CABG, coronary artery bypass graft surgery; CHD, coronary heart disease; CHF, chronic heart failure; L, lovastatin; MI, myocardial infarction; P, pravastatin; R, rosuvastatin; S, simvastatin; TIA, transient ischaemic attack.</p>", "links"=>[], "tags"=>["cardiovascular", "Venous thromboembolism", "Clinical research design", "meta-analyses", "trials"], "article_id"=>245527, "categories"=>["Medicine"], "users"=>["Kazem Rahimi", "Neeraj Bhala", "Pieter Kamphuisen", "Jonathan Emberson", "Sara Biere-Rafi", "Vera Krane", "Michele Robertson", "John Wikstrand", "John McMurray"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001310.t001", "stats"=>{"downloads"=>1, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Summary_of_trials_characteristics_/245527", "title"=>"Summary of trials characteristics.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-09-18 01:32:07"}
  • {"files"=>["https://ndownloader.figshare.com/files/574763"], "description"=>"<p>Effect of statin therapy on separate components of venous thromboembolism.</p>", "links"=>[], "tags"=>["cardiovascular", "Venous thromboembolism", "Clinical research design", "meta-analyses", "statin", "components", "venous"], "article_id"=>245247, "categories"=>["Medicine"], "users"=>["Kazem Rahimi", "Neeraj Bhala", "Pieter Kamphuisen", "Jonathan Emberson", "Sara Biere-Rafi", "Vera Krane", "Michele Robertson", "John Wikstrand", "John McMurray"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001310.g004", "stats"=>{"downloads"=>0, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Effect_of_statin_therapy_on_separate_components_of_venous_thromboembolism_/245247", "title"=>"Effect of statin therapy on separate components of venous thromboembolism.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-09-18 01:27:27"}

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Relative Metric

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