EFFECTS OF PICOTAMIDE, AN ANTITHROMBOXANE AGENT, ON CAROTID ATHEROSCLEROTIC EVOLUTION - A 2-YEAR, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY IN DIABETIC-PATIENTS

Background and Purpose We assessed the effects of longterm treatment with picotamide, an antiplatelet agent with dual antithromboxane activity, on the evolution of early asymptomatic carotid atherosclerotic lesions in diabetic patients. Methods In a double-blind, placebo-controlled, 2-year study, 50 type II normotensive diabetic patients (35 men; mean age, 66+/-5 years) with asymptomatic mild or moderate nonstenotic (<50%) carotid atherosclerotic lesions and negative history of cerebrovascular ischemic events were enrolled and randomly given picotamide (300 mg TID) or the corresponding placebo. A high-resolution, real-time B-scan echographic assessment of carotid arteries was performed at baseline and after 1, 3, 6, 12, 18, and 24 months of double-blind treatment. Prevalence and evolutionary trends of carotid atherosclerotic lesions (number per patient and mean stenosis expressed as percent) were considered as efficacy primary end points. Results At baseline, mean+/-SD numbers of carotid atherosclerotic lesions per patient were 2.7+/-1.8 and 2.2+/-1.2 in the picotamide and placebo groups, respectively. Mean+/-SD percent stenosis was 25.3+/-7% in the picotamide group and 27.3+/-6% in the placebo group. Forty-nine patients completed the study. At month 24, the placebo group (n=24) showed a significant progression in number of carotid atherosclerotic lesions (3.04+/-1.8; P<.02 versus baseline) and in mean percent stenosis (35+/-17%; 95% confidence interval, 33% to 37%; P<.01 versus baseline). In the picotamide group (n=25), mean number of carotid atherosclerotic lesions (2.7+/-1.6) and per cent stenosis (26+/-9%; 95% confidence interval, 24.8% to 27.2%) remained unchanged. At month 24, compared with randomized placebo, lesion numbers (P<.03) and percent stenosis (P<.01) in the picotamide group were significantly lower. During the study, 12 patients experienced major or minor ischemic vascular events (9 in the placebo group and 3 in the picotamide group; P=.07). Conclusions In diabetic patients compared with patients receiving placebo, long-term treatment with picotamide can slow the evolution of early carotid atherosclerotic lesions, inhibiting progression of plaque number and growth.