Triflusal for Preventing Serious Vascular Events in People at High Risk
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 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.
Aspirin Versus Triflusal
Five 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.
Triflusal Versus Placebo
Two 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 Research
No 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.
- Received March 18, 2006.
- Accepted April 12, 2006.
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.