[Clinical efficacy of picotamide].

The effects of picotamide (300 mg b.i.d.) for secondary prevention of cerebral ischemia were compared with the effects of low-dosage aspirin (300 mg/die). Out of the 87 randomized patients, 47 completed a six month period of treatment: 29 patients in the picotamide (group P) with a mean period of 14.5 months, 18 in the aspirin group (group A) with a mean period of 15.2 months. Both showed reduced incidence of further cerebral ischemic episodes in comparison with non treated patients (literature data). Using intention-to-treat analysis, the recurrence of ischemic events (including TIA) was 5.8% in group P and 14.3% in group A. Explanatory analysis yielded similar results: 10.3% of patients in group P and 27.8% in group A had recurrence of cerebral ischemic eposides. Evaluating as endpoints only RIND and stroke, the incidence was 10.3% in group P and 16.7% in group A. In conclusion, picotamide was more effective than aspirin; however the difference was not statistically significant due to the small number of patients. The drug was well tolerated and only two patients dropped out because of side effects. Picotamide did not alter laboratory tests significantly.