LONG-TERM SAFETY AND EFFICACY OF PICOTAMIDE, A DUAL-ACTION ANTITHROMBOXANE AGENT, IN DIABETIC-PATIENTS WITH CAROTID ATHEROSCLEROSIS - A 6-YEAR FOLLOW-UP-STUDY

In a controlled, randomized, 6-year trial the safety and efficacy of p icotamide, a dual-action antithromboxane agent, were assessed in 50 pa tients with type 2 diabetes mellitus at increased risk of thrombotic v ascular events. The patients were randomized to two groups of equal si ze and received 900 mg picotamide daily or placebo. After phase I (dou ble-blind; years 1 - 2), patients receiving placebo were treated, if n ecessary, with antiplatelet drugs (aspirin, ticlopidine) while members of the other group continued to receive 600 mg picotamide daily. In t he course of the study 21 vascular events occurred: 16 in the group re ceiving placebo (fatal myocardial infarction, n = 7; non-fatal stroke, n = 3) anal five in the group receiving drug (fatal myocardial infarc tion, n = 2) (P < 0.005; Fisher's exact test), One patient (placebo gr oup) died of malignant disease. During the initial double-blind phase a total of nine vascular events was observed (six and three in the gro ups receiving placebo and drug, respectively). Picotamide treatment wa s well tolerated and no major side-effects were observed during the st udy periods.