Effects of triflusal on arteriosclerosis progression assessed with high-resolution arterial ultrasound

In order to evaluate the effect of triflusal (2-acetyloxy-4-trifluoromethyl benzoic acid), an orally active antiplatelet agent, on arteriosclerosis pr ogression, a pilot, parallel, double-dummy, double-blind clinical trial vs acetylsalicylic acid (ASA) was carried out in patients with subclinical ath erosclerotic lesions. The trial consisted of a 2-week run-in placebo phase, followed by a 12-month oral treatment with triflusal (600 mg/day) or ASA ( 300 mg/day). The primary variable was identified in the ultrasonic biopsy ( UB) score; the secondary variables were the UB class changes of each arteri al site, the rate of progression (ROP), the intima-media thickness (IMT), a nd the symptoms of arteriosclerosis. Data were evaluated by use of analysis of variance and Chi-square test. Forty-three patients (31 men, 12 women, m ean age 62.8 +/- 8.4 SD) were randomized to triflusal (15 men, 6 women, mea n age 64.3 +/- 6.7) or to ASA (16 men, 6 women, mean age 61.3 +/-9.6). The analysis of variance on the UB score showed no difference between treatment s: the patients' UB scores remained unchanged with no progression, thus ind icating that no patient worsened during treatment. When all arterial sites under evaluation are considered, 86% of the sites in the triflusal group an d 85% in the ASA group remained unchanged. No relevant change was recorded in vital signs and routine laboratory tests. Gastric disturbances were repo rted by two and three patients treated with triflusal and ASA, respectively . In conclusion, triflusal appears as effective as ASA in slowing arteriosc lerosis progression.