[Clinical efficacy of picotamide]

Area of Science:

• Neurology
• Pharmacology
• Cardiovascular Medicine

Background:

• Cerebral ischemia poses a significant risk for recurrent events.
• Secondary prevention strategies are crucial for managing patients post-ischemic episode.
• Low-dose aspirin is a standard treatment, but alternative options are being explored.

Purpose of the Study:

• To compare the efficacy of picotamide with low-dose aspirin for secondary prevention of cerebral ischemia.
• To evaluate the safety and tolerability of picotamide in this patient population.

Main Methods:

• A randomized trial involving 87 patients, with 47 completing six months of treatment.
• Patients were assigned to receive either picotamide (300 mg b.i.d.) or low-dose aspirin (300 mg/die).
• Recurrence of ischemic events, including transient ischemic attacks (TIA), rapidly progressing neurological deficits (RPND), and stroke, were primary endpoints.

Main Results:

• Picotamide showed a lower recurrence rate of ischemic events (5.8%) compared to aspirin (14.3%) in intention-to-treat analysis.
• Explanatory analysis revealed a 10.3% recurrence with picotamide versus 27.8% with aspirin.
• When considering only rapidly progressing neurological deficits (RPND) and stroke, incidence was 10.3% for picotamide and 16.7% for aspirin.
• Picotamide was well-tolerated, with only two dropouts due to side effects and no significant alterations in laboratory tests.

Conclusions:

• Picotamide appears more effective than aspirin for secondary prevention of cerebral ischemia.
• The observed difference in efficacy was not statistically significant due to the small sample size.
• Picotamide represents a potentially safe and effective alternative for managing cerebral ischemia recurrence.