title: Long-term safety and efficacy of picotamide, a dual-action antithromboxane agent, in diabetic patients with carotid atherosclerosis: a 6-year follow-up study.
abstract: In a controlled, randomized, 6-year trial the safety and efficacy of picotamide, a dual-action antithromboxane agent, were assessed in 50 patients with type 2 diabetes mellitus at increased risk of thrombotic vascular events. The patients were randomized to two groups of equal size and received 900 mg picotamide daily or placebo. After phase I (double-blind; years 1 - 2), patients receiving placebo were treated, if necessary, with antiplatelet drugs (aspirin, ticlopidine) while members of the other group continued to receive 600 mg picotamide daily. In the course of the study 21 vascular events occurred: 16 in the group receiving placebo (fatal myocardial infarction, n = 7; non-fatal stroke, n = 3) and five in the group receiving drug (fatal myocardial infarction, n = 2) (P < 0.005; Fisher's exact test). One patient (placebo group) died of malignant disease. During the initial double-blind phase a total of nine vascular events was observed (six and three in the groups receiving placebo and drug, respectively). Picotamide treatment was well tolerated and no major side-effects were observed during the study periods.
authors.affiliation: Department of Internal Medicine, University of Naples, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Coto
authors.forename: U
authors.initials: U
authors.lastname: Oliviero
authors.forename: M
authors.initials: M
authors.lastname: Cocozza
authors.forename: M
authors.initials: M
authors.lastname: Milani
mesh_terms: D000368:Aged; D001161:Arteriosclerosis / Q000150:complications / Q000188:drug therapy*; D048909:Diabetes Complications; D003920:Diabetes Mellitus / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010795:Phthalic Acids / Q000008:administration & dosage* / Q000009:adverse effects; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D013931:Thromboxanes / Q000037:antagonists & inhibitors
chemical_list: D010795:Phthalic Acids; D010975:Platelet Aggregation Inhibitors; D013931:Thromboxanes; C011581:picotamide