Effects of Picotamide, an Antithromboxane Agent, on Carotid Atherosclerotic Evolution

Abstract

Background and Purpose We assessed the effects of long-term 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 percent 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.