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Triflusal for Preventing Serious Vascular Events in People at High Risk

2006; Lippincott Williams & Wilkins; Volume: 37; Issue: 8 Linguagem: Inglês

10.1161/01.str.0000231642.59626.74

1524-4628

Graeme J. Hankey, João Costa, José M. Ferro, Jordi A. Matías‐Guiu, José Álvarez‐Sabín, Ferrán Torres,

Stroke Rehabilitation and Recovery

HomeStrokeVol. 37, No. 8Triflusal for Preventing Serious Vascular Events in People at High Risk Free AccessReview ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessReview ArticlePDF/EPUBTriflusal for Preventing Serious Vascular Events in People at High Risk Graeme J. Hankey, MD, FRCP, João Costa, MD, José M. Ferro, MD, PhD, Jordi Matías-Guiu, MD, PhD, José Alvarez-Sabin, MD, PhD and Ferran Torres, PhD Graeme J. HankeyGraeme J. Hankey From the Neurology Department (J.C.), Santa Maria University Hospital, Lisbon, Portugal; the Department of Neurosciences and Mental Health (J.M.F.), Santa Maria University Hospital, Lisbon, Portugal; the Neurology Department (J.M.-G.), Hospital Clínico San Carlos, Madrid, Spain; the Neurovascular Unit (J.A.-S.), Department of Neurology, Universitat Autònoma de Barcelona, Hospital Vall d'Hebron, Barcelona, Spain; and the Laboratorio de Bioestatística y Epidemiología (F.T.), Universitat Autònoma de Barcelona, Spain, and the Pharmacology Unit, Clinical Trials Unit, Hospital Clínic Barcelona, Spain. , João CostaJoão Costa From the Neurology Department (J.C.), Santa Maria University Hospital, Lisbon, Portugal; the Department of Neurosciences and Mental Health (J.M.F.), Santa Maria University Hospital, Lisbon, Portugal; the Neurology Department (J.M.-G.), Hospital Clínico San Carlos, Madrid, Spain; the Neurovascular Unit (J.A.-S.), Department of Neurology, Universitat Autònoma de Barcelona, Hospital Vall d'Hebron, Barcelona, Spain; and the Laboratorio de Bioestatística y Epidemiología (F.T.), Universitat Autònoma de Barcelona, Spain, and the Pharmacology Unit, Clinical Trials Unit, Hospital Clínic Barcelona, Spain. , José M. FerroJosé M. Ferro From the Neurology Department (J.C.), Santa Maria University Hospital, Lisbon, Portugal; the Department of Neurosciences and Mental Health (J.M.F.), Santa Maria University Hospital, Lisbon, Portugal; the Neurology Department (J.M.-G.), Hospital Clínico San Carlos, Madrid, Spain; the Neurovascular Unit (J.A.-S.), Department of Neurology, Universitat Autònoma de Barcelona, Hospital Vall d'Hebron, Barcelona, Spain; and the Laboratorio de Bioestatística y Epidemiología (F.T.), Universitat Autònoma de Barcelona, Spain, and the Pharmacology Unit, Clinical Trials Unit, Hospital Clínic Barcelona, Spain. , Jordi Matías-GuiuJordi Matías-Guiu From the Neurology Department (J.C.), Santa Maria University Hospital, Lisbon, Portugal; the Department of Neurosciences and Mental Health (J.M.F.), Santa Maria University Hospital, Lisbon, Portugal; the Neurology Department (J.M.-G.), Hospital Clínico San Carlos, Madrid, Spain; the Neurovascular Unit (J.A.-S.), Department of Neurology, Universitat Autònoma de Barcelona, Hospital Vall d'Hebron, Barcelona, Spain; and the Laboratorio de Bioestatística y Epidemiología (F.T.), Universitat Autònoma de Barcelona, Spain, and the Pharmacology Unit, Clinical Trials Unit, Hospital Clínic Barcelona, Spain. , José Alvarez-SabinJosé Alvarez-Sabin From the Neurology Department (J.C.), Santa Maria University Hospital, Lisbon, Portugal; the Department of Neurosciences and Mental Health (J.M.F.), Santa Maria University Hospital, Lisbon, Portugal; the Neurology Department (J.M.-G.), Hospital Clínico San Carlos, Madrid, Spain; the Neurovascular Unit (J.A.-S.), Department of Neurology, Universitat Autònoma de Barcelona, Hospital Vall d'Hebron, Barcelona, Spain; and the Laboratorio de Bioestatística y Epidemiología (F.T.), Universitat Autònoma de Barcelona, Spain, and the Pharmacology Unit, Clinical Trials Unit, Hospital Clínic Barcelona, Spain. and Ferran TorresFerran Torres From the Neurology Department (J.C.), Santa Maria University Hospital, Lisbon, Portugal; the Department of Neurosciences and Mental Health (J.M.F.), Santa Maria University Hospital, Lisbon, Portugal; the Neurology Department (J.M.-G.), Hospital Clínico San Carlos, Madrid, Spain; the Neurovascular Unit (J.A.-S.), Department of Neurology, Universitat Autònoma de Barcelona, Hospital Vall d'Hebron, Barcelona, Spain; and the Laboratorio de Bioestatística y Epidemiología (F.T.), Universitat Autònoma de Barcelona, Spain, and the Pharmacology Unit, Clinical Trials Unit, Hospital Clínic Barcelona, Spain. Originally published22 Jun 2006https://doi.org/10.1161/01.STR.0000231642.59626.74Stroke. 2006;37:2193–2195Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: June 22, 2006: Previous Version 1 Aspirin is still considered the standard treatment for secondary prevention of stroke and other vascular events. Because several studies suggested that triflusal (an antiplatelet agent structurally related to aspirin) may have a better safety profile, and the uncertainty of its efficacy when compared with aspirin, we performed a Cochrane systematic review to determine whether triflusal is an effective and safe treatment for primary and secondary prevention of serious vascular events among people at high risk.1MethodologyRelevant trials were identified in the trials registers of the Stroke, Heart and Peripheral Vascular Diseases Cochrane Review Groups, and by electronic search of the Cochrane Library, MEDLINE, and EMBASE (until October 2004). In addition, we contacted the drug manufacturer which provided the individual patient data from all trials. We considered for analysis randomized and quasi-randomized studies comparing triflusal with placebo or aspirin in people at high risk of vascular events. Two authors (J.C., J.M.F.) independently assessed trial quality and extracted data. The primary outcome was a serious vascular event (nonfatal acute myocardial infarction (AMI), nonfatal ischemic or hemorrhagic stroke, or vascular death). Other efficacy and safety measures collected were frequency of different vascular events, adverse events, minor and major hemorrhages.Main ResultsAspirin Versus TriflusalFive studies enrolled patients with stroke or transient ischemic attack (4 trials; 2944 patients; followed for 6 to 47 months) or AMI (1 trial; 2275 patients; followed for 35 days). Entry criteria were similar within each subgroup of patients. Patient groups were appropriately selected and well matched. The primary outcome in all trials was a composite outcome of vascular events. Trials had no important bias except in 1 study (217 patients). For the primary outcome there was no difference between triflusal and aspirin. Triflusal was associated with a lower frequency of hemorrhages (both minor and major), including hemorrhagic stroke, and aspirin with a lower frequency of nonhemorrhagic gastrointestinal adverse events (mainly dyspepsia). The Figure shows the Peto odds ratio (OR) and 95% CI for these comparisons. The Table shows the numbers needed to harm and the benefit for 1000 patients treated for the comparisons of safety and tolerability where differences were found. Download figureDownload PowerPointSummary of the results of the meta-analysis.Objective Outcomes of Safety and Tolerability Where Differences Existed Between Aspirin and TriflusalNo. of Patients (pts)NNH (95% CI)Benefit for 1000 ptsNNH indicates numbers needed to harm.*Favors triflusal;#favors aspirin.Serious adverse events related to medication*75 (45, 522)13Any hemorrhagic adverse event*20 (16, 28)50Any major hemorrhage (intracranial/systemic)*60 (48, 97)17Any minor hemorrhage*26 (20, 42)38Gastrointestinal hemorrhage*53 (40, 93)19Nonhemorrhagic gastrointestinal adverse events#24 (15, 81)42Triflusal Versus PlaceboTwo trials enrolled patients with unstable angina (n=281) or peripheral arteriopathy (n=122), who were followed for 6 months. Triflusal was associated with a reduction in serious vascular events (OR 2.29; 95% CI, 1.01 to 5.19; OR >1 favors triflusal) and with a higher frequency of adverse events (OR 1.68; 95% CI, 1.00 to 2.80).Conclusions and Implications for Practice and ResearchNo significant differences were found between triflusal and aspirin for secondary prevention of serious vascular events in patients with stroke or transient ischemic attack and AMI. However, our review cannot exclude moderate differences in efficacy. Triflusal was associated with a lower risk of hemorrhagic complications. Future trials should explore its efficacy and safety in other groups of patients who are at high vascular risk and the possible additional benefit of combined antiplatelet therapy for secondary prevention of serious vascular events.FootnotesCorrespondence to João Costa, MD, Serviço de Neurologia, Hospital de Santa Maria, 1649-035 Lisboa, Portugal. E-mail [email protected] References 1 Costa J, Ferro JM, Matias-Guiu J, Alvarez-Sabin J, Torres F. Triusal for preventing serious vascular events in people at high risk. The Cochrane Database of Systematic Reviews. 2005;3: Art. No.: CD004296.pub2. DOI: 10.1002/14651858.CD004296.pub2.Google Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Popova L Modern principles of antiplatelet antithrombotic therapy, Clinical Medicine (Russian Journal), 10.18821/0023-2149-2017-95-7-586-593, 95:7, (586-593) Bousser M (2012) Stroke prevention: an update, Frontiers of Medicine, 10.1007/s11684-012-0178-6, 6:1, (22-34), Online publication date: 1-Mar-2012. Castellanos M, Weksler B and Benavente O (2011) Antiplatelet Therapy for Secondary Prevention of Stroke Stroke, 10.1016/B978-1-4160-5478-8.10058-2, (1147-1172), . Field T and Benavente O (2010) Current Status of Antiplatelet Agents to Prevent Stroke, Current Neurology and Neuroscience Reports, 10.1007/s11910-010-0162-y, 11:1, (6-14), Online publication date: 1-Feb-2011. Montero Domínguez M, González B and Zimmer J (2009) Neuroprotective effects of the anti-inflammatory compound triflusal on ischemia-like neurodegeneration in mouse hippocampal slice cultures occur independent of microglia, Experimental Neurology, 10.1016/j.expneurol.2009.03.023, 218:1, (11-23), Online publication date: 1-Jul-2009. August 2006Vol 37, Issue 8 Advertisement Article InformationMetrics https://doi.org/10.1161/01.STR.0000231642.59626.74 Manuscript receivedMarch 18, 2006Manuscript acceptedApril 12, 2006Originally publishedJune 22, 2006 Keywordscerebrovascular disordersplatelet aggregation inhibitorsmeta-analysisPDF download Advertisement