Comparison of Triflusal with Aspirin in the Secondary Prevention of Atherothrombotic Events; Α Randomised Clinical Trial.
Aged
Aspirin
/ adverse effects
Brain Ischemia
/ diagnosis
Coronary Artery Disease
/ diagnosis
Cyclooxygenase Inhibitors
/ adverse effects
Female
Greece
Hemorrhage
/ chemically induced
Humans
Intracranial Embolism
/ diagnosis
Male
Middle Aged
Myocardial Infarction
/ diagnosis
Platelet Aggregation Inhibitors
/ adverse effects
Recurrence
Risk Factors
Salicylates
/ adverse effects
Secondary Prevention
Stroke
/ diagnosis
Time Factors
Treatment Outcome
Aspirin
bleeding
coronary artery disease
myocardial infarction
stroke
triflusal.
Journal
Current vascular pharmacology
ISSN: 1875-6212
Titre abrégé: Curr Vasc Pharmacol
Pays: United Arab Emirates
ID NLM: 101157208
Informations de publication
Date de publication:
2019
2019
Historique:
received:
01
01
2018
revised:
07
04
2018
accepted:
01
06
2018
pubmed:
6
6
2018
medline:
9
6
2020
entrez:
6
6
2018
Statut:
ppublish
Résumé
Triflusal has demonstrated an efficacy similar to aspirin in the prevention of vascular events in patients with acute myocardial infarction (ΜΙ) and ischaemic stroke but with less bleeding events. We performed a randomised, multicentre, phase 4 clinical trial to compare the clinical efficacy and safety of triflusal versus aspirin, administered for 12 months in patients eligible to receive a cyclooxygenase-1 (COX-1) inhibitor. Patients with stable coronary artery disease or with a history of non-cardioembolic ischaemic stroke were randomly assigned to receive either triflusal 300 mg twice or 600 mg once daily or aspirin 100 mg once daily for 12 months. The primary efficacy endpoint was the composite of: (a) ΜΙ, (b) stroke (ischaemic or haemorrhagic), or, (c) death from vascular causes for the entire follow-up period. The primary safety endpoints were the rate of bleeding events as defined by Bleeding Academic Research Consortium (BARC) criteria. At 12-month follow-up, an equivalent result was revealed between the triflusal (n=559) and aspirin (n=560) in primary efficacy endpoint. Specifically, the combined efficacy outcome rate (i.e. MI, stroke or death from vascular causes) difference was equal to -1.3% (95% confidence interval -1.1 to 3.5) and lied within the a-priori defined equivalence interval (p<0.001). Regarding the primary safety endpoints, patients on triflusal treatment were 50% less likely to develop bleeding events according to the BARC criteria, and especially any clinically overt sign of haemorrhage that requires diagnostic studies, hospitalisation or special treatment (BARC type 2). The efficacy of triflusal in the secondary prevention of vascular events is similar to aspirin when administered for 12 months. Importantly, triflusal significantly reduced the incidence of ΜΙ and showed a better safety profile compared with aspirin. (ASpirin versus Triflusal for Event Reduction In Atherothrombosis Secondary prevention, ASTERIAS trial; Clinical Trials.gov Identifier: NCT02616497).
Sections du résumé
BACKGROUND
Triflusal has demonstrated an efficacy similar to aspirin in the prevention of vascular events in patients with acute myocardial infarction (ΜΙ) and ischaemic stroke but with less bleeding events.
OBJECTIVE
We performed a randomised, multicentre, phase 4 clinical trial to compare the clinical efficacy and safety of triflusal versus aspirin, administered for 12 months in patients eligible to receive a cyclooxygenase-1 (COX-1) inhibitor.
METHODS
Patients with stable coronary artery disease or with a history of non-cardioembolic ischaemic stroke were randomly assigned to receive either triflusal 300 mg twice or 600 mg once daily or aspirin 100 mg once daily for 12 months. The primary efficacy endpoint was the composite of: (a) ΜΙ, (b) stroke (ischaemic or haemorrhagic), or, (c) death from vascular causes for the entire follow-up period. The primary safety endpoints were the rate of bleeding events as defined by Bleeding Academic Research Consortium (BARC) criteria.
RESULTS
At 12-month follow-up, an equivalent result was revealed between the triflusal (n=559) and aspirin (n=560) in primary efficacy endpoint. Specifically, the combined efficacy outcome rate (i.e. MI, stroke or death from vascular causes) difference was equal to -1.3% (95% confidence interval -1.1 to 3.5) and lied within the a-priori defined equivalence interval (p<0.001). Regarding the primary safety endpoints, patients on triflusal treatment were 50% less likely to develop bleeding events according to the BARC criteria, and especially any clinically overt sign of haemorrhage that requires diagnostic studies, hospitalisation or special treatment (BARC type 2).
CONCLUSION
The efficacy of triflusal in the secondary prevention of vascular events is similar to aspirin when administered for 12 months. Importantly, triflusal significantly reduced the incidence of ΜΙ and showed a better safety profile compared with aspirin. (ASpirin versus Triflusal for Event Reduction In Atherothrombosis Secondary prevention, ASTERIAS trial; Clinical Trials.gov Identifier: NCT02616497).
Identifiants
pubmed: 29866011
pii: CVP-EPUB-90919
doi: 10.2174/1570161116666180605090520
doi:
Substances chimiques
Cyclooxygenase Inhibitors
0
Platelet Aggregation Inhibitors
0
Salicylates
0
triflusal
1Z0YFI05OO
Aspirin
R16CO5Y76E
Banques de données
ClinicalTrials.gov
['NCT02616497']
Types de publication
Clinical Trial, Phase IV
Comparative Study
Equivalence Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
635-643Informations de copyright
Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.