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MI&#44; vascular death and death from all causes&#44; and adverse events&#46; Risk ratios &#40;RR&#41; with 95&#37; confidence intervals &#40;CI&#41; were the measure of effect used&#46; The analysis was performed on an intention-to-treat basis&#59; meta-analysis was performed with fixed and random effect models depending on heterogeneity &#40;I<span class="elsevierStyleSup">2</span> cut-off of 50&#37;&#41;&#44; and subgroup analyses were conducted for age&#44; gender and type of fibrate used&#46; Additionally&#44; a sensitivity analysis was performed based on the trials&#8217; risk of bias and concomitant use of statins&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Results</span><p id="par0030" class="elsevierStylePara elsevierViewall">Thirteen trials met the inclusion criteria&#44; with a total of 16<span class="elsevierStyleHsp" style=""></span>112 participants&#46; Six trials included only male participants&#46; 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95&#37; CI 0&#46;80-0&#46;93&#44; I<span class="elsevierStyleSup">2</span> 24&#37;&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41; that remained even after the exclusion of clofibrate trials &#40;RR 0&#46;85&#44; 95&#37; CI 0&#46;76-0&#46;94&#59; I<span class="elsevierStyleSup">2</span> 47&#37;&#41;&#46; Regarding adverse events&#44; two studies reported the risk of myopathy and six studies the risk of gastrointestinal &#40;GI&#41; events&#59; when pooling data regarding these adverse events&#44; there were no statistically significant differences between the fibrate and placebo groups &#40;RR for myopathy 0&#46;86&#44; 95&#37; CI 0&#46;31-2&#46;35&#44; I<span class="elsevierStyleSup">2</span> 0&#37;&#59; RR for GI events 1&#46;02&#44; 95&#37; CI 1&#46;00-1&#46;04&#44; I<span class="elsevierStyleSup">2</span> 42&#37;&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0040" class="elsevierStylePara elsevierViewall">In subgroup analysis&#44; there was no difference in the protective effect of fibrates for the primary outcome based on age &#40;older vs&#46; younger than 65 years&#41; or gender&#46; However&#44; in subgroup analysis for the type of fibrate &#40;clofibrate&#44; bezafibrate and gemfibrozil&#41;&#44; only clofibrate had a significant beneficial effect on the primary outcome &#40;RR 0&#46;86&#44; 95&#37; CI 0&#46;74-1&#46;00&#44; I<span class="elsevierStyleSup">2</span> 51&#37;&#41;&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">In sensitivity analysis&#44; only one study compared the addition of fibrate therapy &#40;fenofibrate&#41; to simvastatin and simvastatin therapy alone&#44; and revealed no difference between arms in the primary composite outcome &#40;RR 0&#46;9&#44; 95&#37; CI 0&#46;74-1&#46;09&#41;&#46; It is noteworthy that sensitivity analysis including only trials classified as &#8216;low risk&#8217; of bias showed evidence of a significant preventive effect of fibrates on the primary outcome &#40;RR 0&#46;85&#44; 95&#37; CI 0&#46;79-0&#46;91&#44; I<span class="elsevierStyleSup">2</span> 47&#37;&#41;&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Conclusion</span><p id="par0050" class="elsevierStylePara elsevierViewall">Fibrates may have a protective effect for the composite outcome of non-fatal stroke&#44; non-fatal MI and vascular death in people with a previous history of CVD&#59; however&#44; this protection is mainly due to the reduction in the risk of non-fatal or fatal MI events&#46; Nonetheless&#44; these results largely rely on studies including clofibrate&#44; a drug withdrawn from the market in 2002&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Comment</span><p id="par0055" class="elsevierStylePara elsevierViewall">Fibrates are a drug class used predominantly in dyslipidemias due to their established effect in lowering triglycerides and increasing HDL cholesterol&#46;<a class="elsevierStyleCrossRefs" href="#bib0030"><span class="elsevierStyleSup">2&#44;3</span></a> However&#44; their effect on cardiovascular risk still generates debate&#44; with several clinical trials reporting inconsistent results&#46; A systematic review and meta-analysis from 2010 found a reduction in the risk of major cardiovascular events&#44; mainly by prevention of coronary events&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">4</span></a> The specific role of fibrates in primary and secondary prevention&#44; however&#44; is still unclear&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">The present systematic review and meta-analysis suggests that fibrates may play a role in the secondary prevention of cardiovascular events&#44; mainly MI&#46; These results&#44; however&#44; must be interpreted with caution&#46; Five of the thirteen included trials employed clofibrate&#44; a drug withdrawn from the market in 2002 due to safety concerns related to increased overall mortality&#46; Of note&#44; excluding these trials from the analysis&#44; the protective effect of fibrates was only maintained for the secondary outcome of MI&#46; Furthermore&#44; the limited number of studies weakens the results and validity of some of the analysis performed&#44; particularly the comparison between different fibrates and the assessment of the value of addition of fibrates to statin therapy&#46; Finally&#44; when interpreting the results&#44; it should be noted that moderate heterogeneity was found in the majority of outcomes&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">Nevertheless&#44; certain interesting conclusions can be inferred from this analysis&#44; especially the absence of significant differences in the effect of fibrates between genders and different age groups&#44; and between fibrates and placebo regarding adverse effects&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Clinical implications</span><p id="par0070" class="elsevierStylePara elsevierViewall">This review suggests that fibrates may play a role in the secondary prevention of cardiovascular events&#46; However&#44; rather than changing indications for initiating fibrates&#44; the review constitutes further evidence to be considered when deciding on lipid-modifying therapy in dyslipidemic patients with a history of CVD&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Conflicts of interest</span><p id="par0075" class="elsevierStylePara elsevierViewall">The authors have no conflicts of interest to declare&#46;</p></span></span>"
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    "fechaRecibido" => "2016-04-28"
    "fechaAceptado" => "2016-05-31"
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            1 => "Cardiovascular events"
            2 => "Stroke"
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            4 => "Systematic review"
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          "palabras" => array:5 [
            0 => "Fibratos"
            1 => "Eventos cardiovasculares"
            2 => "Acidente vascular cerebral"
            3 => "Preven&#231;&#227;o secund&#225;ria"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">The influence of fibrates on cardiovascular risk has been the focus of several clinical trials&#46; This Cochrane Collaboration Systematic Review evaluated the efficacy of fibrates for secondary prevention of cardiovascular events and stroke&#44; analyzing 13 randomized controlled trials&#44; in a total of 16<span class="elsevierStyleHsp" style=""></span>112 participants with a history of cardiovascular disease&#46; Fibrates showed a protective effect for the composite outcome of non-fatal stroke&#44; non-fatal myocardial infarction &#40;MI&#41; and vascular death&#44; mainly due to reduction in the risk of non-fatal or fatal MI&#46; Nonetheless&#44; these results largely relied on studies including clofibrate&#44; a drug withdrawn from the market in 2002&#46; No statistically significant differences regarding adverse events were found between fibrates and placebo&#46; Although insufficient to support the routine prescription of fibrates in this setting&#44; this evidence should be taken into account when deciding on lipid-modifying therapy in dyslipidemic patients with a history of cardiovascular disease&#46;</p></span>"
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        "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">A influ&#234;ncia dos fibratos no risco cardiovascular tem sido o foco de v&#225;rios ensaios cl&#237;nicos&#46; Esta revis&#227;o sistem&#225;tica da <span class="elsevierStyleItalic">Cochrane Collaboration</span> avaliou o efeito dos fibratos na preven&#231;&#227;o secund&#225;ria de eventos cardiovasculares e acidente vascular cerebral&#44; incluindo 13 ensaios cl&#237;nicos aleatorizados&#44; num total de 16<span class="elsevierStyleHsp" style=""></span>112 participantes com antecedentes de doen&#231;a cardiovascular&#46; A terap&#234;utica com fibratos demonstrou um efeito protetor no <span class="elsevierStyleItalic">outcome</span> composto acidente vascular isqu&#233;mico n&#227;o fatal&#44; enfarte agudo do mioc&#225;rdio n&#227;o fatal e morte de causa vascular&#44; especialmente devido &#224; redu&#231;&#227;o do risco de enfarte agudo do mioc&#225;rdio fatal e n&#227;o fatal&#46; No entanto&#44; estes resultados baseiam-se em grande parte em estudos que incluem o clofibrato&#44; f&#225;rmaco retirado do mercado em 2002&#46; N&#227;o foram encontradas diferen&#231;as estatisticamente significativas relativamente a efeitos adversos entre fibratos e placebo&#46; Embora insuficientes para sustentar uma prescri&#231;&#227;o rotineira de fibratos neste contexto&#44; estes dados devem ser tidos em conta aquando da decis&#227;o terap&#234;utica em doentes dislipid&#233;micos com antecedentes de doen&#231;a cardiovascular&#46;</p></span>"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0010">Please cite this article as&#58; Pires da Rosa G&#44; Lib&#226;nio D&#44; Azevedo LF&#46; An&#225;lise da Revis&#227;o Cochrane&#58; fibratos na preven&#231;&#227;o secund&#225;ria de doen&#231;a cardiovascular e acidente vascular cerebral&#46; Rev Port Cardiol&#46; 2017&#59;36&#58;55&#8211;58&#46;</p>"
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          "leyenda" => "<p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">CI&#58; confidence interval&#59; MI&#58; myocardial infarction&#59; RR&#58; risk ratio&#46;</p><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">GRADE Working Group grades of evidence&#58; High quality&#58; We are very confident that the true effect lies close to that of the estimate of the effect&#59; Moderate quality&#58; We are moderately confident in the effect estimate&#58; the true effect is likely to be close to the estimate of the effect&#44; but there is a possibility that it is substantially different&#59; Low quality&#58; Our confidence in the effect estimate is limited&#58; the true effect may be substantially different from the estimate of the effect&#59; Very low quality&#58; We have very little confidence in the effect estimate&#58; the true effect is likely to be substantially different from the estimate of effect&#46;</p><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Quality of evidence&#58; more than 75&#37; of included studies did not report details of randomization&#44; and four trials withdrawn or lost to follow-up less than 20&#37;&#46;</p>"
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                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td-with-role" title="table-head ; entry_with_role_rowhead " align="left" valign="top" scope="col">Fibrates compared to control for secondary prevention of cardiovascular disease and stroke&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Patient or population&#58; patients with previous cardiovascular disease&#44; transient ischemic attack&#44; or stroke<br>Setting&#58; secondary prevention<br>Intervention&#58; fibrates<br>Comparison&#58; control&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td-with-role" title="table-head ; entry_with_role_rowhead " align="left" valign="top" scope="col">Outcomes&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " colspan="2" align="center" valign="top" scope="col">Anticipated absolute effects<a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">a</span></a> &#40;95&#37; CI&#41;</th><th class="td" title="table-head  " align="left" valign="top" scope="col">Relative effect &#40;95&#37; CI&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col">No&#46; of participants &#40;studies&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col">Quality of evidence &#40;GRADE&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col">I<span class="elsevierStyleSup">2</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr><tr title="table-row"><th class="td" title="table-head  " align="" valign="top" scope="col">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col">Risk with control&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col">Risk with fibrates&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="" valign="top" scope="col">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="" valign="top" scope="col">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="" valign="top" scope="col">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="" valign="top" scope="col">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">Composite outcome of non-fatal stroke&#44; non-fatal MI&#44; and vascular death &#40;primary outcome&#41;</td><td class="td" title="table-entry  " colspan="2" align="left" valign="top">Study population</td><td class="td" title="table-entry  " align="left" valign="top">RR 0&#46;88 &#40;0&#46;83-0&#46;94&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">16<span class="elsevierStyleHsp" style=""></span>064 &#40;12 RCTs&#41;</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">&#8853;&#8853;&#8853;&#9675; Moderate</td><td class="td" title="table-entry  " rowspan="2" align="char" valign="top">45&#37;</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">233 per 1000&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">205 per 1000 &#40;194-219&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="" valign="top">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">Composite outcome of non-fatal stroke&#44; non-fatal stroke&#44; non-fatal myocardial infarction&#44; and vascular death without clofibrate</td><td class="td" title="table-entry  " colspan="2" align="left" valign="top">Study population</td><td class="td" title="table-entry  " align="left" valign="top">RR 0&#46;90 &#40;0&#46;79-1&#46;03&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">10<span class="elsevierStyleHsp" style=""></span>320 &#40;7 RCTs&#41;</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">&#8853;&#8853;&#9675;&#9675; Low</td><td class="td" title="table-entry  " rowspan="2" align="char" valign="top">50&#37;</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">204 per 1000&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">183 per 1000 &#40;161-210&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="" valign="top">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">Myocardial infarction &#40;non-fatal or fatal&#41; during the treatment and scheduled follow-up period</td><td class="td" title="table-entry  " colspan="2" align="left" valign="top">Study population</td><td class="td" title="table-entry  " align="left" valign="top">RR 0&#46;86 &#40;0&#46;80-0&#46;93&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">13<span class="elsevierStyleHsp" style=""></span>942 &#40;10 RCTs&#41;</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">&#8853;&#8853;&#8853;&#9675; Moderate</td><td class="td" title="table-entry  " rowspan="2" align="char" valign="top">24&#37;</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">190 per 1000&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">163 per 1000 &#40;152-177&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="" valign="top">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">Death from any cause during the treatment and scheduled follow-up period</td><td class="td" title="table-entry  " colspan="2" align="left" valign="top">Study population</td><td class="td" title="table-entry  " align="left" valign="top">RR 0&#46;98 &#40;0&#46;91-1&#46;06&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">13<span class="elsevierStyleHsp" style=""></span>653 &#40;10 RCTs&#41;</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">&#8853;&#8853;&#9675;&#9675; Low</td><td class="td" title="table-entry  " rowspan="2" align="char" valign="top">23&#37;</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">185 per 1000&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">182 per 1000 &#40;169-196&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="" valign="top">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">Stroke &#40;ischemic or hemorrhagic&#44; non-fatal or fatal&#41; during the treatment and scheduled follow-up period</td><td class="td" title="table-entry  " colspan="2" align="left" valign="top">Study population</td><td class="td" title="table-entry  " align="left" valign="top">RR 1&#46;03 &#40;0&#46;91-1&#46;16&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">11<span class="elsevierStyleHsp" style=""></span>719 &#40;6 RCTs&#41;</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">&#8853;&#8853;&#9675;&#9675; Low</td><td class="td" title="table-entry  " rowspan="2" align="char" valign="top">11&#37;</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">83 per 1000&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">86 per 1000 &#40;76-96&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="" valign="top">&nbsp;\t\t\t\t\t\t\n
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              "nota" => "<p class="elsevierStyleNotepara" id="npar0005">The risk in the intervention group &#40;and its 95&#37; confidence interval&#41; is based on the assumed risk in the comparison group and the relative effect of the intervention &#40;and its 95&#37; CI&#41;&#46;</p>"
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          "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Summary of findings for the main comparison and most important secondary outcomes&#46;</p>"
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      "titulo" => "References"
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                      "titulo" => "Fibrates for secondary prevention of cardiovascular disease and stroke"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:3 [
                            0 => "D&#46; Wang"
                            1 => "B&#46; Liu"
                            2 => "W&#46; Tao"
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                        ]
                      ]
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Review article
Analysis of the Cochrane Review: Fibrates for secondary prevention of cardiovascular disease and stroke
Análise da Revisão Cochrane: fibratos na prevenção secundária de doença cardiovascular e acidente vascular cerebral
Gilberto Pires da Rosaa, Diogo Libâniob, Luís Filipe Azevedoc,d,e,
Corresponding author
a Serviço de Medicina Interna, Centro Hospitalar de São João, Porto, Portugal
b Serviço de Gastrenterologia, Instituto Português de Oncologia do Porto (IPO-Porto), Porto, Portugal
c Center for Health Technology and Services Research (CINTESIS), Faculdade de Medicina, Universidade do Porto, Porto, Portugal
d Departamento de Ciências da Informação e da Decisão em Saúde (CIDES), Faculdade de Medicina, Universidade do Porto, Porto, Portugal
e Cochrane Portugal – Unidade do Porto, Porto, Portugal
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Clinical question</span><p id="par0005" class="elsevierStylePara elsevierViewall">What is the efficacy of fibrates for secondary prevention of cardiovascular events and stroke&#63;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Objectives</span><p id="par0010" class="elsevierStylePara elsevierViewall">To assess the efficacy of fibrates for the prevention of serious vascular events including myocardial infarction &#40;MI&#41;&#44; stroke&#44; and vascular death in individuals with previous cardiovascular disease &#40;CVD&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">1</span></a></p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Methods</span><p id="par0015" class="elsevierStylePara elsevierViewall">A systematic review and meta-analysis of randomized controlled trials &#40;RCTs&#41; was conducted&#44; in which the incidence of cardiovascular events in patients at high recurrent risk for cardiovascular events and stroke &#40;due to previous history of CVD&#41; was compared in individuals treated with a fibrate&#44; and controls &#40;placebo or no treatment&#41;&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The bibliographic search &#40;last search in October 2014&#41; was performed on six electronic databases including the Cochrane Central Register of Controlled Trials &#40;CENTRAL&#41;&#44; MEDLINE and EMBASE&#44; registries of ongoing trials and databases of conference abstracts&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">The authors included RCTs comparing fibrate therapy with placebo or no treatment&#44; regardless of the duration of treatment and follow-up&#46; The primary outcome was a composite outcome of non-fatal stroke&#44; non-fatal MI and vascular death&#46; Secondary outcomes included the separate outcomes of stroke&#44; MI&#44; vascular death and death from all causes&#44; and adverse events&#46; Risk ratios &#40;RR&#41; with 95&#37; confidence intervals &#40;CI&#41; were the measure of effect used&#46; The analysis was performed on an intention-to-treat basis&#59; meta-analysis was performed with fixed and random effect models depending on heterogeneity &#40;I<span class="elsevierStyleSup">2</span> cut-off of 50&#37;&#41;&#44; and subgroup analyses were conducted for age&#44; gender and type of fibrate used&#46; Additionally&#44; a sensitivity analysis was performed based on the trials&#8217; risk of bias and concomitant use of statins&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Results</span><p id="par0030" class="elsevierStylePara elsevierViewall">Thirteen trials met the inclusion criteria&#44; with a total of 16<span class="elsevierStyleHsp" style=""></span>112 participants&#46; Six trials included only male participants&#46; Two recruited patients with a history of cerebrovascular disease&#44; one recruited patients with cardiovascular disease &#40;coronary heart disease or stroke&#41;&#44; nine recruited patients with coronary heart disease and one recruited patients with lower peripheral arterial disease and controlled angina&#46; Clofibrate was used in five trials&#44; bezafibrate in three&#44; fenofibrate in two and gemfibrozil in three&#46; Two trials used statins in both the intervention and the control group&#46; Only one of the trials included a no-treatment arm&#44; the others using placebo as the comparator&#46; The minimum treatment duration was 12 months and the maximum was eight years&#46; Risk of bias was classified as &#8216;low&#8217; in trials with appropriate sequence generation and blinded outcome assessment classified as low risk&#44; and as &#8216;high&#8217; in trials in which the same parameters were classified as high or unclear risk&#46; Six trials were classified as &#8216;low risk of bias&#8217; and seven as &#8216;high risk&#8217;&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Concerning the primary composite outcome &#40;of non-fatal stroke&#44; non-fatal MI and vascular death&#41;&#44; a protective effect of fibrates was found using a fixed-effect meta-analysis model &#40;risk ratio 0&#46;88&#44; 95&#37; CI 0&#46;83-0&#46;94&#44; I<span class="elsevierStyleSup">2</span> 45&#37;&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46; However&#44; a random-effects model when excluding trials on clofibrate &#40;which was withdrawn from the market in 2002 due to safety concerns&#41; failed to show effectiveness in preventing this composite outcome &#40;RR 0&#46;90&#44; 95&#37; CI 0&#46;79-1&#46;03&#59; I<span class="elsevierStyleSup">2</span> 50&#37;&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46; Nevertheless&#44; when analyzing the outcome of MI separately&#44; the fixed-effect model showed a significant risk reduction &#40;RR 0&#46;86&#44; 95&#37; CI 0&#46;80-0&#46;93&#44; I<span class="elsevierStyleSup">2</span> 24&#37;&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41; that remained even after the exclusion of clofibrate trials &#40;RR 0&#46;85&#44; 95&#37; CI 0&#46;76-0&#46;94&#59; I<span class="elsevierStyleSup">2</span> 47&#37;&#41;&#46; Regarding adverse events&#44; two studies reported the risk of myopathy and six studies the risk of gastrointestinal &#40;GI&#41; events&#59; when pooling data regarding these adverse events&#44; there were no statistically significant differences between the fibrate and placebo groups &#40;RR for myopathy 0&#46;86&#44; 95&#37; CI 0&#46;31-2&#46;35&#44; I<span class="elsevierStyleSup">2</span> 0&#37;&#59; RR for GI events 1&#46;02&#44; 95&#37; CI 1&#46;00-1&#46;04&#44; I<span class="elsevierStyleSup">2</span> 42&#37;&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0040" class="elsevierStylePara elsevierViewall">In subgroup analysis&#44; there was no difference in the protective effect of fibrates for the primary outcome based on age &#40;older vs&#46; younger than 65 years&#41; or gender&#46; However&#44; in subgroup analysis for the type of fibrate &#40;clofibrate&#44; bezafibrate and gemfibrozil&#41;&#44; only clofibrate had a significant beneficial effect on the primary outcome &#40;RR 0&#46;86&#44; 95&#37; CI 0&#46;74-1&#46;00&#44; I<span class="elsevierStyleSup">2</span> 51&#37;&#41;&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">In sensitivity analysis&#44; only one study compared the addition of fibrate therapy &#40;fenofibrate&#41; to simvastatin and simvastatin therapy alone&#44; and revealed no difference between arms in the primary composite outcome &#40;RR 0&#46;9&#44; 95&#37; CI 0&#46;74-1&#46;09&#41;&#46; It is noteworthy that sensitivity analysis including only trials classified as &#8216;low risk&#8217; of bias showed evidence of a significant preventive effect of fibrates on the primary outcome &#40;RR 0&#46;85&#44; 95&#37; CI 0&#46;79-0&#46;91&#44; I<span class="elsevierStyleSup">2</span> 47&#37;&#41;&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Conclusion</span><p id="par0050" class="elsevierStylePara elsevierViewall">Fibrates may have a protective effect for the composite outcome of non-fatal stroke&#44; non-fatal MI and vascular death in people with a previous history of CVD&#59; however&#44; this protection is mainly due to the reduction in the risk of non-fatal or fatal MI events&#46; Nonetheless&#44; these results largely rely on studies including clofibrate&#44; a drug withdrawn from the market in 2002&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Comment</span><p id="par0055" class="elsevierStylePara elsevierViewall">Fibrates are a drug class used predominantly in dyslipidemias due to their established effect in lowering triglycerides and increasing HDL cholesterol&#46;<a class="elsevierStyleCrossRefs" href="#bib0030"><span class="elsevierStyleSup">2&#44;3</span></a> However&#44; their effect on cardiovascular risk still generates debate&#44; with several clinical trials reporting inconsistent results&#46; A systematic review and meta-analysis from 2010 found a reduction in the risk of major cardiovascular events&#44; mainly by prevention of coronary events&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">4</span></a> The specific role of fibrates in primary and secondary prevention&#44; however&#44; is still unclear&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">The present systematic review and meta-analysis suggests that fibrates may play a role in the secondary prevention of cardiovascular events&#44; mainly MI&#46; These results&#44; however&#44; must be interpreted with caution&#46; Five of the thirteen included trials employed clofibrate&#44; a drug withdrawn from the market in 2002 due to safety concerns related to increased overall mortality&#46; Of note&#44; excluding these trials from the analysis&#44; the protective effect of fibrates was only maintained for the secondary outcome of MI&#46; Furthermore&#44; the limited number of studies weakens the results and validity of some of the analysis performed&#44; particularly the comparison between different fibrates and the assessment of the value of addition of fibrates to statin therapy&#46; Finally&#44; when interpreting the results&#44; it should be noted that moderate heterogeneity was found in the majority of outcomes&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">Nevertheless&#44; certain interesting conclusions can be inferred from this analysis&#44; especially the absence of significant differences in the effect of fibrates between genders and different age groups&#44; and between fibrates and placebo regarding adverse effects&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Clinical implications</span><p id="par0070" class="elsevierStylePara elsevierViewall">This review suggests that fibrates may play a role in the secondary prevention of cardiovascular events&#46; However&#44; rather than changing indications for initiating fibrates&#44; the review constitutes further evidence to be considered when deciding on lipid-modifying therapy in dyslipidemic patients with a history of CVD&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Conflicts of interest</span><p id="par0075" class="elsevierStylePara elsevierViewall">The authors have no conflicts of interest to declare&#46;</p></span></span>"
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            2 => "Stroke"
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            0 => "Fibratos"
            1 => "Eventos cardiovasculares"
            2 => "Acidente vascular cerebral"
            3 => "Preven&#231;&#227;o secund&#225;ria"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">The influence of fibrates on cardiovascular risk has been the focus of several clinical trials&#46; This Cochrane Collaboration Systematic Review evaluated the efficacy of fibrates for secondary prevention of cardiovascular events and stroke&#44; analyzing 13 randomized controlled trials&#44; in a total of 16<span class="elsevierStyleHsp" style=""></span>112 participants with a history of cardiovascular disease&#46; Fibrates showed a protective effect for the composite outcome of non-fatal stroke&#44; non-fatal myocardial infarction &#40;MI&#41; and vascular death&#44; mainly due to reduction in the risk of non-fatal or fatal MI&#46; Nonetheless&#44; these results largely relied on studies including clofibrate&#44; a drug withdrawn from the market in 2002&#46; No statistically significant differences regarding adverse events were found between fibrates and placebo&#46; Although insufficient to support the routine prescription of fibrates in this setting&#44; this evidence should be taken into account when deciding on lipid-modifying therapy in dyslipidemic patients with a history of cardiovascular disease&#46;</p></span>"
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        "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">A influ&#234;ncia dos fibratos no risco cardiovascular tem sido o foco de v&#225;rios ensaios cl&#237;nicos&#46; Esta revis&#227;o sistem&#225;tica da <span class="elsevierStyleItalic">Cochrane Collaboration</span> avaliou o efeito dos fibratos na preven&#231;&#227;o secund&#225;ria de eventos cardiovasculares e acidente vascular cerebral&#44; incluindo 13 ensaios cl&#237;nicos aleatorizados&#44; num total de 16<span class="elsevierStyleHsp" style=""></span>112 participantes com antecedentes de doen&#231;a cardiovascular&#46; A terap&#234;utica com fibratos demonstrou um efeito protetor no <span class="elsevierStyleItalic">outcome</span> composto acidente vascular isqu&#233;mico n&#227;o fatal&#44; enfarte agudo do mioc&#225;rdio n&#227;o fatal e morte de causa vascular&#44; especialmente devido &#224; redu&#231;&#227;o do risco de enfarte agudo do mioc&#225;rdio fatal e n&#227;o fatal&#46; No entanto&#44; estes resultados baseiam-se em grande parte em estudos que incluem o clofibrato&#44; f&#225;rmaco retirado do mercado em 2002&#46; N&#227;o foram encontradas diferen&#231;as estatisticamente significativas relativamente a efeitos adversos entre fibratos e placebo&#46; Embora insuficientes para sustentar uma prescri&#231;&#227;o rotineira de fibratos neste contexto&#44; estes dados devem ser tidos em conta aquando da decis&#227;o terap&#234;utica em doentes dislipid&#233;micos com antecedentes de doen&#231;a cardiovascular&#46;</p></span>"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0010">Please cite this article as&#58; Pires da Rosa G&#44; Lib&#226;nio D&#44; Azevedo LF&#46; An&#225;lise da Revis&#227;o Cochrane&#58; fibratos na preven&#231;&#227;o secund&#225;ria de doen&#231;a cardiovascular e acidente vascular cerebral&#46; Rev Port Cardiol&#46; 2017&#59;36&#58;55&#8211;58&#46;</p>"
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          "leyenda" => "<p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">CI&#58; confidence interval&#59; MI&#58; myocardial infarction&#59; RR&#58; risk ratio&#46;</p><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">GRADE Working Group grades of evidence&#58; High quality&#58; We are very confident that the true effect lies close to that of the estimate of the effect&#59; Moderate quality&#58; We are moderately confident in the effect estimate&#58; the true effect is likely to be close to the estimate of the effect&#44; but there is a possibility that it is substantially different&#59; Low quality&#58; Our confidence in the effect estimate is limited&#58; the true effect may be substantially different from the estimate of the effect&#59; Very low quality&#58; We have very little confidence in the effect estimate&#58; the true effect is likely to be substantially different from the estimate of effect&#46;</p><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Quality of evidence&#58; more than 75&#37; of included studies did not report details of randomization&#44; and four trials withdrawn or lost to follow-up less than 20&#37;&#46;</p>"
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                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Patient or population&#58; patients with previous cardiovascular disease&#44; transient ischemic attack&#44; or stroke<br>Setting&#58; secondary prevention<br>Intervention&#58; fibrates<br>Comparison&#58; control&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td-with-role" title="table-head ; entry_with_role_rowhead " align="left" valign="top" scope="col">Outcomes&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " colspan="2" align="center" valign="top" scope="col">Anticipated absolute effects<a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">a</span></a> &#40;95&#37; CI&#41;</th><th class="td" title="table-head  " align="left" valign="top" scope="col">Relative effect &#40;95&#37; CI&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col">No&#46; of participants &#40;studies&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col">Quality of evidence &#40;GRADE&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col">I<span class="elsevierStyleSup">2</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr><tr title="table-row"><th class="td" title="table-head  " align="" valign="top" scope="col">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col">Risk with control&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col">Risk with fibrates&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="" valign="top" scope="col">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="" valign="top" scope="col">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="" valign="top" scope="col">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="" valign="top" scope="col">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">Composite outcome of non-fatal stroke&#44; non-fatal MI&#44; and vascular death &#40;primary outcome&#41;</td><td class="td" title="table-entry  " colspan="2" align="left" valign="top">Study population</td><td class="td" title="table-entry  " align="left" valign="top">RR 0&#46;88 &#40;0&#46;83-0&#46;94&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">16<span class="elsevierStyleHsp" style=""></span>064 &#40;12 RCTs&#41;</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">&#8853;&#8853;&#8853;&#9675; Moderate</td><td class="td" title="table-entry  " rowspan="2" align="char" valign="top">45&#37;</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">233 per 1000&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">205 per 1000 &#40;194-219&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="" valign="top">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">Composite outcome of non-fatal stroke&#44; non-fatal stroke&#44; non-fatal myocardial infarction&#44; and vascular death without clofibrate</td><td class="td" title="table-entry  " colspan="2" align="left" valign="top">Study population</td><td class="td" title="table-entry  " align="left" valign="top">RR 0&#46;90 &#40;0&#46;79-1&#46;03&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">10<span class="elsevierStyleHsp" style=""></span>320 &#40;7 RCTs&#41;</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">&#8853;&#8853;&#9675;&#9675; Low</td><td class="td" title="table-entry  " rowspan="2" align="char" valign="top">50&#37;</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">204 per 1000&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">183 per 1000 &#40;161-210&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="" valign="top">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">Myocardial infarction &#40;non-fatal or fatal&#41; during the treatment and scheduled follow-up period</td><td class="td" title="table-entry  " colspan="2" align="left" valign="top">Study population</td><td class="td" title="table-entry  " align="left" valign="top">RR 0&#46;86 &#40;0&#46;80-0&#46;93&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">13<span class="elsevierStyleHsp" style=""></span>942 &#40;10 RCTs&#41;</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">&#8853;&#8853;&#8853;&#9675; Moderate</td><td class="td" title="table-entry  " rowspan="2" align="char" valign="top">24&#37;</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">190 per 1000&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">163 per 1000 &#40;152-177&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="" valign="top">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">Death from any cause during the treatment and scheduled follow-up period</td><td class="td" title="table-entry  " colspan="2" align="left" valign="top">Study population</td><td class="td" title="table-entry  " align="left" valign="top">RR 0&#46;98 &#40;0&#46;91-1&#46;06&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">13<span class="elsevierStyleHsp" style=""></span>653 &#40;10 RCTs&#41;</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">&#8853;&#8853;&#9675;&#9675; Low</td><td class="td" title="table-entry  " rowspan="2" align="char" valign="top">23&#37;</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">185 per 1000&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">182 per 1000 &#40;169-196&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="" valign="top">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">Stroke &#40;ischemic or hemorrhagic&#44; non-fatal or fatal&#41; during the treatment and scheduled follow-up period</td><td class="td" title="table-entry  " colspan="2" align="left" valign="top">Study population</td><td class="td" title="table-entry  " align="left" valign="top">RR 1&#46;03 &#40;0&#46;91-1&#46;16&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">11<span class="elsevierStyleHsp" style=""></span>719 &#40;6 RCTs&#41;</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">&#8853;&#8853;&#9675;&#9675; Low</td><td class="td" title="table-entry  " rowspan="2" align="char" valign="top">11&#37;</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">83 per 1000&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">86 per 1000 &#40;76-96&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="" valign="top">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
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Article information
ISSN: 21742049
Original language: English
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Revista Portuguesa de Cardiologia (English edition)
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