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Ferran Torres - One of the best experts on this subject based on the ideXlab platform.
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Comparative bioavailability study of Triflusal oral solution vs. Triflusal capsules in healthy subjects. A single, randomized, two-way cross-over, open-label phase I study.
Arzneimittel-Forschung, 2011Co-Authors: Iñaki Izquierdo, Javier Borja, Sandra Rovira, Pilar Pelagio, Ferran Torres, Jesús Cebrecos, Julián García-rafanellAbstract:Triflusal (CAS 322-79-2) is an antiplatelet agent that irreversibly acetylates cyclooxygenase isoform 1 (COX-1) and therefore inhibits thromboxane biosynthesis. The main metabolite of Triflusal, 2-hydroxy-4-trifluoromethyl benzoic acid (HTB), possesses also antiaggregant activity. Recently a new oral 600 mg (10 ml) solution form of Triflusal has been developed. The purpose of this clinical trial was to study the relative bioavailability of the new oral solution of Triflusal versus the capsules formulation, both administered as a single dose. This was a randomized, two-way, cross-over, open-label, single-site phase I clinical trial, in 24 healthy volunteers who received Triflusal as 600 mg oral solution and as two 300 mg capsules in a single administration separated by a washout period of at least 17 days. Blood samples were collected and plasma concentrations of HTB were measured. Pharmacokinetic parameters used for bioequivalence assessment included AUC(0-t), AUC(0-inf) and Cmax. The formulations were considered bioequivalent if the geometric mean ratios of AUC(0-t), AUC(0-inf) and Cmax were within the predetermined equivalence range (80% to 125%). Tolerability was based on the recording of adverse events (AEs), physical examination, electrocardiogram (ECG) and laboratory tests. The parameters for bioequivalence, mean [SD] values were as follows: AUC(0-t) (microg x h/ml): 3574.08 [628.17] for Triflusal oral solution and 3901.78 [698.43] for Triflusal capsules; AUC(0-infinity) (microg x h/ml): 4089.21 [842.54] for Triflusal oral solution and 4471.33 [905.93] for Triflusal capsules; Cmax, (microg/ml): 91.24 [12.88] for Triflusal oral solution and 88.61 [13.46] for Triflusal capsules; Cmax/AUC(0-infinity) (h(-1)): 0.03 (0.00) for Triflusal oral solution and 0.02 (0.00) for Triflusal capsules. The 90% confidence intervals for the ratio experimental/control by analysis of variance after log transformed AUC(0-infinity), AUC(0-t), and Cmax were within 80% to 125%. Similar results were found for the data without log transformation. All adverse events were of mild or moderate intensity and all subjects recovered. Nine and 12 subjects reported at least one adverse event during treatment with Triflusal oral solution and with Triflusal capsules, respectively. The most frequently reported adverse events were headache and dizziness. It was concluded that the 600-mg solution of Triflusal appeared to be bioequivalent to the reference formulation capsules. Both formulations were well tolerated.
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Triflusal for preventing serious vascular events in people at high risk
Stroke, 2006Co-Authors: João Costa, José M. Ferro, Jordi Matiasguiu, Jose Alvarezsabin, Ferran TorresAbstract: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.1 Relevant trials were identified in the trials registers of the Stroke, Heart and Peripheral Vascular Diseases Cochrane Review Groups, and by electronic search of the …
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The Cochrane Library - Triflusal for Preventing Serious Vascular Events in People at High Risk
Stroke, 2006Co-Authors: João Costa, José M. Ferro, Jordi Matias-guiu, José Alvarez-sabín, Ferran TorresAbstract: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.1 Relevant trials were identified in the trials registers of the Stroke, Heart and Peripheral Vascular Diseases Cochrane Review Groups, and by electronic search of the …
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Triflusal for preventing serious vascular events in people at high risk.
The Cochrane database of systematic reviews, 2005Co-Authors: João Costa, José M. Ferro, Jordi Matias-guiu, José Alvarez-sabín, Ferran TorresAbstract:BACKGROUND Aspirin is the standard treatment for secondary prevention of stroke and other vascular events. Several studies suggest that Triflusal may have a better safety profile. OBJECTIVES To determine in people at high risk of vascular events whether Triflusal is an effective and safe treatment for primary and secondary prevention of serious vascular events. SEARCH STRATEGY We searched the trials registers of the following Cochrane Review Groups: Stroke Group (last searched October 2004), Heart Group, Peripheral Vascular Diseases Group and Metabolic and Endocrine Disorders Group (last searched May 2003). In addition, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2003), MEDLINE (1977 to 2003) and EMBASE (1980 to 2003). We searched reference lists and contacted researchers in the field, authors of relevant trials and the drug manufacturer. SELECTION CRITERIA Randomised and quasi-randomised studies comparing Triflusal with placebo or aspirin in people at high risk of vascular events. DATA COLLECTION AND ANALYSIS Two authors independently assessed trial quality and extracted data. The primary outcome was a serious vascular event (non-fatal acute myocardial infarction (AMI), non-fatal 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 RESULTS (1) Aspirin versus Triflusal: five studies enrolled patients with stroke or transient ischemic attack (TIA) (4 trials; 2944 patients; followed for 6 to 47 months) or AMI (one 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 one study (217 patients). For the primary outcome of a serious vascular event there was no significant difference between Triflusal and aspirin; the odds ratio (OR) was 1.04 (95% confidence interval (CI) 0.87 to 1.23). Significant differences were found for frequency of hemorrhages, both minor (OR 1.60, 95% CI 1.31 to 1.95) and major (OR 2.34, 95% CI 1.58 to 3.46) and for non-hemorrhagic gastrointestinal adverse events (OR 0.84, 95% CI 0.75 to 0.95). Sensitivity analysis of well versus poorly allocated trials showed no significant differences. (2) Triflusal versus placebo: two trials enrolled patients with unstable angina (281 patients) or peripheral arteriopathy (122 patients), 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 greater than 1 favours Triflusal) and with a higher frequency of adverse events (OR 1.68, 95% CI 1.00 to 2.80). AUTHORS' CONCLUSIONS No significant differences were found between Triflusal and aspirin for secondary prevention of serious vascular events in patients with stroke or TIA and AMI. However, our review cannot exclude moderate differences in efficacy. Triflusal was associated with a lower risk of hemorrhagic complications.
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Comparison of Triflusal and Aspirin for Prevention of Vascular Events in Patients After Cerebral Infarction The TACIP Study: A Randomized, Double-Blind, Multicenter Trial
Stroke, 2003Co-Authors: Jordi Matias-guiu, Ferran Torres, José M. Ferro, José Alvarez-sabín, M. Dolores Jiménez, Aida Lago, Teresa Pinho E MeloAbstract:Background and Purpose— The efficacy of the antiplatelet agent Triflusal for prevention of vascular events after stroke has been reported in a pilot study. However, there is a need to confirm those results in a larger study. Methods— We performed a randomized, double-blind, multicenter study to test the efficacy of Triflusal (600 mg/d) versus aspirin (325 mg/d) for prevention of vascular events in patients with stroke or transient ischemic attack (Triflusal versus Aspirin in Cerebral Infarction Prevention [TACIP]). We assessed a combined end point (incidence of nonfatal ischemic stroke, nonfatal acute myocardial infarction, or vascular death) as well as the incidence of these events separately and the incidence of major hemorrhage. Results— Of 2113 patients, 1058 received Triflusal and 1055 aspirin. The mean follow-up period was 30.1 months. The incidence of combined end point (13.1% for Triflusal, 12.4% for aspirin) as well the survival analysis (hazard ratio [HR] for Triflusal versus aspirin, 1.09; 95% ...
Julián García-rafanell - One of the best experts on this subject based on the ideXlab platform.
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Comparative bioavailability study of Triflusal oral solution vs. Triflusal capsules in healthy subjects. A single, randomized, two-way cross-over, open-label phase I study.
Arzneimittel-Forschung, 2011Co-Authors: Iñaki Izquierdo, Javier Borja, Sandra Rovira, Pilar Pelagio, Ferran Torres, Jesús Cebrecos, Julián García-rafanellAbstract:Triflusal (CAS 322-79-2) is an antiplatelet agent that irreversibly acetylates cyclooxygenase isoform 1 (COX-1) and therefore inhibits thromboxane biosynthesis. The main metabolite of Triflusal, 2-hydroxy-4-trifluoromethyl benzoic acid (HTB), possesses also antiaggregant activity. Recently a new oral 600 mg (10 ml) solution form of Triflusal has been developed. The purpose of this clinical trial was to study the relative bioavailability of the new oral solution of Triflusal versus the capsules formulation, both administered as a single dose. This was a randomized, two-way, cross-over, open-label, single-site phase I clinical trial, in 24 healthy volunteers who received Triflusal as 600 mg oral solution and as two 300 mg capsules in a single administration separated by a washout period of at least 17 days. Blood samples were collected and plasma concentrations of HTB were measured. Pharmacokinetic parameters used for bioequivalence assessment included AUC(0-t), AUC(0-inf) and Cmax. The formulations were considered bioequivalent if the geometric mean ratios of AUC(0-t), AUC(0-inf) and Cmax were within the predetermined equivalence range (80% to 125%). Tolerability was based on the recording of adverse events (AEs), physical examination, electrocardiogram (ECG) and laboratory tests. The parameters for bioequivalence, mean [SD] values were as follows: AUC(0-t) (microg x h/ml): 3574.08 [628.17] for Triflusal oral solution and 3901.78 [698.43] for Triflusal capsules; AUC(0-infinity) (microg x h/ml): 4089.21 [842.54] for Triflusal oral solution and 4471.33 [905.93] for Triflusal capsules; Cmax, (microg/ml): 91.24 [12.88] for Triflusal oral solution and 88.61 [13.46] for Triflusal capsules; Cmax/AUC(0-infinity) (h(-1)): 0.03 (0.00) for Triflusal oral solution and 0.02 (0.00) for Triflusal capsules. The 90% confidence intervals for the ratio experimental/control by analysis of variance after log transformed AUC(0-infinity), AUC(0-t), and Cmax were within 80% to 125%. Similar results were found for the data without log transformation. All adverse events were of mild or moderate intensity and all subjects recovered. Nine and 12 subjects reported at least one adverse event during treatment with Triflusal oral solution and with Triflusal capsules, respectively. The most frequently reported adverse events were headache and dizziness. It was concluded that the 600-mg solution of Triflusal appeared to be bioequivalent to the reference formulation capsules. Both formulations were well tolerated.
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Letter by Borja and García-Rafanell Regarding Article, “Guidelines for the Prevention of Stroke in Patients With Stroke or Transient Ischemic Attack: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Associa
Stroke, 2011Co-Authors: Javier Borja, Julián García-rafanellAbstract:To the Editor: In “Guidelines for the Prevention of Stroke in Patients With Stroke or Transient Ischemic Attack,”1 the authors mention that “Triflusal has been examined only in a pilot trial.” This information is not correct and is misleading for the reader. Neither the Triflusal versus Aspirin in Cerebral Infarction Prevention (TACIP) study,2 nor a meta analysis of 4 clinical trials comparing Triflusal with aspirin in patients with stroke or transient ischemic attack3 were mentioned. The TACIP study, the most important study of Triflusal in this kind of patient, was a randomized, double …
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Triflusal versus Aspirin for the Prevention of Stroke
Progress in Neurotherapeutics and Neuropsychopharmacology, 2007Co-Authors: Antonio Culebras, Javier Borja, Julián García-rafanellAbstract:ABSTRACT Antiplatelet agents represent an important part of the therapeutic armamentarium in the prevention of stroke. Triflusal is an antiplatelet agent structurally related to salicylates but not derived from acetylsalicylic acid. Like aspirin, Triflusal irreversibly acetylates cyclo-oxygenase isoform 1 (COX-1) and therefore inhibits thromboxane biosynthesis. Triflusal is rapidly absorbed after oral administration, with an absorption half life of 0.44 hours. Evidence of the efficacy and safety of Triflusal is derived from clinical trials performed in patients with unstable angina, acute myocardial infarction, stroke, aortocoronary by-pass, atrial fibrillation, valve replacement, and asthmatic patients intolerant to aspirin and/or non-steroidal antiinflamatory drugs (NSAID). The Triflusal versus Aspirin for the Prevention of Infarction: A Randomized Stroke Study (TAPIRSS) study was performed to explore the efficacy and safety of Triflusal versus aspirin in the prevention of vascular complications in patients with a previous TIA or ischemic stroke in a Latin American population. In this pilot study differences between Triflusal and aspirin in the prevention of vascular complications after TIA or ischemic stroke were not observed. Hemorrhagic risk was lower with Triflusal than with aspirin. The TAPIRSS study contributed evidence on the efficacy and safety of Triflusal as a valid alternative to aspirin in the prevention of vascular events in patients with ischemic stroke or TIA.
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Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic Attack
Stroke, 2006Co-Authors: Javier Borja, Iñaki Izquierdo, Julián García-rafanellAbstract:To the Editor: In the Guidelines for Prevention of Stroke in Patients with Ischemic Stroke or Transient Ischemic Attack,1 the authors did not include a mention of 3 important clinical trials: the Triflusal versus Aspirin in Cerebral Infarction Prevention (TACIP)2, Triflusal versus Aspirin for Prevention of Infarction: a Randomized Stroke Study (TAPIRSS),3 and the National Study for Prevention of Embolism in Atrial Fibrillation (NASPEAF)4 studies. The TACIP2 and Triflusal versus Aspirin for Prevention of Infarction: a Randomized Stroke Study (TAPIRSS)3 studies, performed in 2107 and 431 patients, …
Javier Borja - One of the best experts on this subject based on the ideXlab platform.
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Antiplatelet therapy: new insights on the secondary prevention of stroke
NATIONAL JOURNAL OF NEUROLOGY, 2019Co-Authors: Julián García Rafanell, Javier BorjaAbstract:Antiplatelet agents represent an important part of the therapeutic armamentarium in the prevention of stroke. Among them, aspirin is the gold standard but its chronic use has been associated with gastric intolerance, gastrointestinal and systemic hemorrhages and drug-resistance. Triflusal is a new antiplatelet agent from the family of salicylates but is not derived from aspirin and has a more selective mechanism of action : inhibition of thromboxane A2 in the platelet with no effect on prostacyclin biosynthesis in the endothelium. In the quest for the search of new antiplatelet agents, Triflusal has shown a similar relative risk reduction than aspirin for the prevention of stroke but with reduced severe hemorrhagic side effects. The efficacy and better safety profile of Triflusal vs aspirin in the secondary prevention of stroke has been demonstrated in major, randomized and double blind clinical trials and confirmed after a long term study with a mean follow up of 17 years, as well as in a Cochrane meta-analysis. Aspirin, but not Triflusal, increased antihypertensive therapy requirements during long term treatment in the secondary prevention of stroke. In patients with atrial fibrillation, the combination of oral anticoagulants with Triflusal has shown increased efficacy versus the standard oral single anticoagulation treatment with no increase of haemorrhagic risk. Studies have shown that the risk of upper gastrointestinal bleeding associated with the use of Triflusal was negligible whereas the hemorrhagic risk associated with the use of aspirin, including low doses aspirin, was evident. Triflusal was well tolerated in asthmatic patients with aspirin-exacerbated –respiratory-diseases. The efficacy of Triflusal in secondary prevention of stroke and its better safety profile when compared to aspirin has been recognized in important International Guidelines including the European Stroke Organization Guidelines.
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Comparative bioavailability study of Triflusal oral solution vs. Triflusal capsules in healthy subjects. A single, randomized, two-way cross-over, open-label phase I study.
Arzneimittel-Forschung, 2011Co-Authors: Iñaki Izquierdo, Javier Borja, Sandra Rovira, Pilar Pelagio, Ferran Torres, Jesús Cebrecos, Julián García-rafanellAbstract:Triflusal (CAS 322-79-2) is an antiplatelet agent that irreversibly acetylates cyclooxygenase isoform 1 (COX-1) and therefore inhibits thromboxane biosynthesis. The main metabolite of Triflusal, 2-hydroxy-4-trifluoromethyl benzoic acid (HTB), possesses also antiaggregant activity. Recently a new oral 600 mg (10 ml) solution form of Triflusal has been developed. The purpose of this clinical trial was to study the relative bioavailability of the new oral solution of Triflusal versus the capsules formulation, both administered as a single dose. This was a randomized, two-way, cross-over, open-label, single-site phase I clinical trial, in 24 healthy volunteers who received Triflusal as 600 mg oral solution and as two 300 mg capsules in a single administration separated by a washout period of at least 17 days. Blood samples were collected and plasma concentrations of HTB were measured. Pharmacokinetic parameters used for bioequivalence assessment included AUC(0-t), AUC(0-inf) and Cmax. The formulations were considered bioequivalent if the geometric mean ratios of AUC(0-t), AUC(0-inf) and Cmax were within the predetermined equivalence range (80% to 125%). Tolerability was based on the recording of adverse events (AEs), physical examination, electrocardiogram (ECG) and laboratory tests. The parameters for bioequivalence, mean [SD] values were as follows: AUC(0-t) (microg x h/ml): 3574.08 [628.17] for Triflusal oral solution and 3901.78 [698.43] for Triflusal capsules; AUC(0-infinity) (microg x h/ml): 4089.21 [842.54] for Triflusal oral solution and 4471.33 [905.93] for Triflusal capsules; Cmax, (microg/ml): 91.24 [12.88] for Triflusal oral solution and 88.61 [13.46] for Triflusal capsules; Cmax/AUC(0-infinity) (h(-1)): 0.03 (0.00) for Triflusal oral solution and 0.02 (0.00) for Triflusal capsules. The 90% confidence intervals for the ratio experimental/control by analysis of variance after log transformed AUC(0-infinity), AUC(0-t), and Cmax were within 80% to 125%. Similar results were found for the data without log transformation. All adverse events were of mild or moderate intensity and all subjects recovered. Nine and 12 subjects reported at least one adverse event during treatment with Triflusal oral solution and with Triflusal capsules, respectively. The most frequently reported adverse events were headache and dizziness. It was concluded that the 600-mg solution of Triflusal appeared to be bioequivalent to the reference formulation capsules. Both formulations were well tolerated.
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Letter by Borja and García-Rafanell Regarding Article, “Guidelines for the Prevention of Stroke in Patients With Stroke or Transient Ischemic Attack: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Associa
Stroke, 2011Co-Authors: Javier Borja, Julián García-rafanellAbstract:To the Editor: In “Guidelines for the Prevention of Stroke in Patients With Stroke or Transient Ischemic Attack,”1 the authors mention that “Triflusal has been examined only in a pilot trial.” This information is not correct and is misleading for the reader. Neither the Triflusal versus Aspirin in Cerebral Infarction Prevention (TACIP) study,2 nor a meta analysis of 4 clinical trials comparing Triflusal with aspirin in patients with stroke or transient ischemic attack3 were mentioned. The TACIP study, the most important study of Triflusal in this kind of patient, was a randomized, double …
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Gastrointestinal safety of Triflusal solution in healthy volunteers: a proof of concept endoscopic study.
European journal of clinical pharmacology, 2011Co-Authors: Rosa-maría Antonijoan, Analia Azaro, Esther Donado, Iris Blanch, I Izquierdo, S Sainz, J Balanzo, Ignasi Gich, Javier Borja, Manuel-josé BarbanojAbstract:Purpose Triflusal is an antiplatelet agent that irreversibly acetylates cyclooxygenase isoform 1 (COX-1) and therefore inhibits thromboxane biosynthesis. It was initially marketed as capsules containing 300 mg of active substance. In 2006 a new 600 mg (10 ml) oral solution form of Triflusal was authorized in Spain. The primary aim of this study was to compare the gastrointestinal safety of the new Triflusal oral solution with Triflusal capsules in healthy volunteers.
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Triflusal versus Aspirin for the Prevention of Stroke
Progress in Neurotherapeutics and Neuropsychopharmacology, 2007Co-Authors: Antonio Culebras, Javier Borja, Julián García-rafanellAbstract:ABSTRACT Antiplatelet agents represent an important part of the therapeutic armamentarium in the prevention of stroke. Triflusal is an antiplatelet agent structurally related to salicylates but not derived from acetylsalicylic acid. Like aspirin, Triflusal irreversibly acetylates cyclo-oxygenase isoform 1 (COX-1) and therefore inhibits thromboxane biosynthesis. Triflusal is rapidly absorbed after oral administration, with an absorption half life of 0.44 hours. Evidence of the efficacy and safety of Triflusal is derived from clinical trials performed in patients with unstable angina, acute myocardial infarction, stroke, aortocoronary by-pass, atrial fibrillation, valve replacement, and asthmatic patients intolerant to aspirin and/or non-steroidal antiinflamatory drugs (NSAID). The Triflusal versus Aspirin for the Prevention of Infarction: A Randomized Stroke Study (TAPIRSS) study was performed to explore the efficacy and safety of Triflusal versus aspirin in the prevention of vascular complications in patients with a previous TIA or ischemic stroke in a Latin American population. In this pilot study differences between Triflusal and aspirin in the prevention of vascular complications after TIA or ischemic stroke were not observed. Hemorrhagic risk was lower with Triflusal than with aspirin. The TAPIRSS study contributed evidence on the efficacy and safety of Triflusal as a valid alternative to aspirin in the prevention of vascular events in patients with ischemic stroke or TIA.
José M. Ferro - One of the best experts on this subject based on the ideXlab platform.
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A randomized, double-blind, placebo controlled-trial of Triflusal in mild cognitive impairment: the TRIMCI study.
Alzheimer disease and associated disorders, 2008Co-Authors: Teresa Gomez-isla, José M. Ferro, Rafael Blesa, Mercè Boada, Jordi Clarimón, Teodoro Del Ser, Gemma Domenech, Beatriz Gómez-ansón, Jose M. Manubens, J.m. Martinez-lageAbstract:Background Amnestic mild cognitive impairment represents, in many cases, the earliest clinical phases of Alzheimer disease. Anti-inflammatory agents have epidemiologic support as drugs potentially beneficial in Alzheimer disease. In vivo studies have shown that Triflusal and its active metabolite 2-hydroxy-4-trifluoromethyl-benzoic acid have potent anti-inflammatory actions in the central nervous system. Methods We conducted a randomized, double-blind, placebo-controlled trial of Triflusal in patients with amnestic mild cognitive impairment. Subjects were randomly assigned to receive 900 mg of Triflusal or placebo for 18 months. The primary outcome was a change in Cognitive subscale of the Alzheimer Disease Assessment Scale; conversion to dementia was a secondary outcome. Results A slow rate of recruitment forced a premature cessation of the study. Two hundred and fifty-seven subjects were enrolled and followed-up for an average of 13 months. The significance level was not reached for the primary outcome even though a trend in favor of Triflusal was observed. However, there was a significant difference in the probability of progression to dementia of Alzheimer's type with a lower risk in the Triflusal compared with the placebo group (hazard ratio, 2.10; 95% confidence interval, 1.10-4.01; P=0.024). Conclusions In this study, Triflusal therapy was associated with a significant lower rate of conversion to dementia that is likely to be clinically relevant. Because the trial was prematurely halted, these results should be interpreted with caution and require further confirmation.
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Triflusal for preventing serious vascular events in people at high risk
Stroke, 2006Co-Authors: João Costa, José M. Ferro, Jordi Matiasguiu, Jose Alvarezsabin, Ferran TorresAbstract: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.1 Relevant trials were identified in the trials registers of the Stroke, Heart and Peripheral Vascular Diseases Cochrane Review Groups, and by electronic search of the …
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The Cochrane Library - Triflusal for Preventing Serious Vascular Events in People at High Risk
Stroke, 2006Co-Authors: João Costa, José M. Ferro, Jordi Matias-guiu, José Alvarez-sabín, Ferran TorresAbstract: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.1 Relevant trials were identified in the trials registers of the Stroke, Heart and Peripheral Vascular Diseases Cochrane Review Groups, and by electronic search of the …
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Triflusal for preventing serious vascular events in people at high risk.
The Cochrane database of systematic reviews, 2005Co-Authors: João Costa, José M. Ferro, Jordi Matias-guiu, José Alvarez-sabín, Ferran TorresAbstract:BACKGROUND Aspirin is the standard treatment for secondary prevention of stroke and other vascular events. Several studies suggest that Triflusal may have a better safety profile. OBJECTIVES To determine in people at high risk of vascular events whether Triflusal is an effective and safe treatment for primary and secondary prevention of serious vascular events. SEARCH STRATEGY We searched the trials registers of the following Cochrane Review Groups: Stroke Group (last searched October 2004), Heart Group, Peripheral Vascular Diseases Group and Metabolic and Endocrine Disorders Group (last searched May 2003). In addition, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2003), MEDLINE (1977 to 2003) and EMBASE (1980 to 2003). We searched reference lists and contacted researchers in the field, authors of relevant trials and the drug manufacturer. SELECTION CRITERIA Randomised and quasi-randomised studies comparing Triflusal with placebo or aspirin in people at high risk of vascular events. DATA COLLECTION AND ANALYSIS Two authors independently assessed trial quality and extracted data. The primary outcome was a serious vascular event (non-fatal acute myocardial infarction (AMI), non-fatal 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 RESULTS (1) Aspirin versus Triflusal: five studies enrolled patients with stroke or transient ischemic attack (TIA) (4 trials; 2944 patients; followed for 6 to 47 months) or AMI (one 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 one study (217 patients). For the primary outcome of a serious vascular event there was no significant difference between Triflusal and aspirin; the odds ratio (OR) was 1.04 (95% confidence interval (CI) 0.87 to 1.23). Significant differences were found for frequency of hemorrhages, both minor (OR 1.60, 95% CI 1.31 to 1.95) and major (OR 2.34, 95% CI 1.58 to 3.46) and for non-hemorrhagic gastrointestinal adverse events (OR 0.84, 95% CI 0.75 to 0.95). Sensitivity analysis of well versus poorly allocated trials showed no significant differences. (2) Triflusal versus placebo: two trials enrolled patients with unstable angina (281 patients) or peripheral arteriopathy (122 patients), 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 greater than 1 favours Triflusal) and with a higher frequency of adverse events (OR 1.68, 95% CI 1.00 to 2.80). AUTHORS' CONCLUSIONS No significant differences were found between Triflusal and aspirin for secondary prevention of serious vascular events in patients with stroke or TIA and AMI. However, our review cannot exclude moderate differences in efficacy. Triflusal was associated with a lower risk of hemorrhagic complications.
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Comparison of Triflusal and Aspirin for Prevention of Vascular Events in Patients After Cerebral Infarction The TACIP Study: A Randomized, Double-Blind, Multicenter Trial
Stroke, 2003Co-Authors: Jordi Matias-guiu, Ferran Torres, José M. Ferro, José Alvarez-sabín, M. Dolores Jiménez, Aida Lago, Teresa Pinho E MeloAbstract:Background and Purpose— The efficacy of the antiplatelet agent Triflusal for prevention of vascular events after stroke has been reported in a pilot study. However, there is a need to confirm those results in a larger study. Methods— We performed a randomized, double-blind, multicenter study to test the efficacy of Triflusal (600 mg/d) versus aspirin (325 mg/d) for prevention of vascular events in patients with stroke or transient ischemic attack (Triflusal versus Aspirin in Cerebral Infarction Prevention [TACIP]). We assessed a combined end point (incidence of nonfatal ischemic stroke, nonfatal acute myocardial infarction, or vascular death) as well as the incidence of these events separately and the incidence of major hemorrhage. Results— Of 2113 patients, 1058 received Triflusal and 1055 aspirin. The mean follow-up period was 30.1 months. The incidence of combined end point (13.1% for Triflusal, 12.4% for aspirin) as well the survival analysis (hazard ratio [HR] for Triflusal versus aspirin, 1.09; 95% ...
Jordi Matias-guiu - One of the best experts on this subject based on the ideXlab platform.
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The Cochrane Library - Triflusal for Preventing Serious Vascular Events in People at High Risk
Stroke, 2006Co-Authors: João Costa, José M. Ferro, Jordi Matias-guiu, José Alvarez-sabín, Ferran TorresAbstract: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.1 Relevant trials were identified in the trials registers of the Stroke, Heart and Peripheral Vascular Diseases Cochrane Review Groups, and by electronic search of the …
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Triflusal for preventing serious vascular events in people at high risk.
The Cochrane database of systematic reviews, 2005Co-Authors: João Costa, José M. Ferro, Jordi Matias-guiu, José Alvarez-sabín, Ferran TorresAbstract:BACKGROUND Aspirin is the standard treatment for secondary prevention of stroke and other vascular events. Several studies suggest that Triflusal may have a better safety profile. OBJECTIVES To determine in people at high risk of vascular events whether Triflusal is an effective and safe treatment for primary and secondary prevention of serious vascular events. SEARCH STRATEGY We searched the trials registers of the following Cochrane Review Groups: Stroke Group (last searched October 2004), Heart Group, Peripheral Vascular Diseases Group and Metabolic and Endocrine Disorders Group (last searched May 2003). In addition, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2003), MEDLINE (1977 to 2003) and EMBASE (1980 to 2003). We searched reference lists and contacted researchers in the field, authors of relevant trials and the drug manufacturer. SELECTION CRITERIA Randomised and quasi-randomised studies comparing Triflusal with placebo or aspirin in people at high risk of vascular events. DATA COLLECTION AND ANALYSIS Two authors independently assessed trial quality and extracted data. The primary outcome was a serious vascular event (non-fatal acute myocardial infarction (AMI), non-fatal 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 RESULTS (1) Aspirin versus Triflusal: five studies enrolled patients with stroke or transient ischemic attack (TIA) (4 trials; 2944 patients; followed for 6 to 47 months) or AMI (one 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 one study (217 patients). For the primary outcome of a serious vascular event there was no significant difference between Triflusal and aspirin; the odds ratio (OR) was 1.04 (95% confidence interval (CI) 0.87 to 1.23). Significant differences were found for frequency of hemorrhages, both minor (OR 1.60, 95% CI 1.31 to 1.95) and major (OR 2.34, 95% CI 1.58 to 3.46) and for non-hemorrhagic gastrointestinal adverse events (OR 0.84, 95% CI 0.75 to 0.95). Sensitivity analysis of well versus poorly allocated trials showed no significant differences. (2) Triflusal versus placebo: two trials enrolled patients with unstable angina (281 patients) or peripheral arteriopathy (122 patients), 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 greater than 1 favours Triflusal) and with a higher frequency of adverse events (OR 1.68, 95% CI 1.00 to 2.80). AUTHORS' CONCLUSIONS No significant differences were found between Triflusal and aspirin for secondary prevention of serious vascular events in patients with stroke or TIA and AMI. However, our review cannot exclude moderate differences in efficacy. Triflusal was associated with a lower risk of hemorrhagic complications.
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Comparison of Triflusal and Aspirin for Prevention of Vascular Events in Patients After Cerebral Infarction The TACIP Study: A Randomized, Double-Blind, Multicenter Trial
Stroke, 2003Co-Authors: Jordi Matias-guiu, Ferran Torres, José M. Ferro, José Alvarez-sabín, M. Dolores Jiménez, Aida Lago, Teresa Pinho E MeloAbstract:Background and Purpose— The efficacy of the antiplatelet agent Triflusal for prevention of vascular events after stroke has been reported in a pilot study. However, there is a need to confirm those results in a larger study. Methods— We performed a randomized, double-blind, multicenter study to test the efficacy of Triflusal (600 mg/d) versus aspirin (325 mg/d) for prevention of vascular events in patients with stroke or transient ischemic attack (Triflusal versus Aspirin in Cerebral Infarction Prevention [TACIP]). We assessed a combined end point (incidence of nonfatal ischemic stroke, nonfatal acute myocardial infarction, or vascular death) as well as the incidence of these events separately and the incidence of major hemorrhage. Results— Of 2113 patients, 1058 received Triflusal and 1055 aspirin. The mean follow-up period was 30.1 months. The incidence of combined end point (13.1% for Triflusal, 12.4% for aspirin) as well the survival analysis (hazard ratio [HR] for Triflusal versus aspirin, 1.09; 95% ...
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Triflusal VERSUS ASPIRIN IN SECONDARY STROKE PREVENTION:RESULTS OF TACIP STUDY
Stroke, 2001Co-Authors: Jordi Matias-guiu, José M. Ferro, José Alvarez-sabín, Ferran TorresAbstract:73 TACIP was a multicentre, double-blind, randomised, parallel trial comparing the efficacy and safety of Triflusal (600 mg/od) and ASA (325 mg/od) in patients who had a recent TIA or non disabling stroke. The primary end-point was the combined occurrence of non-fatal stroke, non-fatal AMI or cardiovascular death. Any of them separately was a secondary end-point, as well as total mortality, major systemic or cerebral hemorrhage and systemic thromboembolism. Forty-three centres in Spain and Portugal participated in the trial. A total of 2108 patients were evaluated with a mean follow-up of 31 months. There were no significant differences between both groups regarding to baseline characteristics. Main results were: The incidence of major and minor hemorrhages were higher in ASA than in Triflusal group (24.5% vs 16.4%; p Conclusion: Triflusal and low-dose ASA have a similar efficacy in secondary stroke prevention. Major and minor hemorrhages were significantly reduced by Triflusal. Triflusal is a safer alternative to aspirin in the secondary prevention of stroke.
