Is cilostazol safe for long-term prevention of recurrence in patients with stroke?

This study investigated whether the use of cilostazol (Pletal) treatment is safe for long-term use in patients with stroke. Researchers suggested that this treatment is safe and appropriate for long-term treatment.

A stroke occurs when a blood vessel that deliveries blood to the brain is blocked. The abilities controlled by these cells are lost. Some patients have a higher risk of having a second stroke. For these patients, antiplatelet medication is necessary. This treatment prevents the formation of blood clots. Prior studies showed that the effectiveness of this treatment is even better with two antiplatelet agents. This combined treatment with aspirin and clopidogrel decreases the risk of a second stroke. However, long-term treatment is associated with the risk of major bleeding.

Previous studies showed that cilostazol also improves the risk of a second stroke. Moreover, this agent was not associated with an increased risk of major bleeding. It is not clear, whether the use of aspirin or clopidogrel combined with cilostazol is a safe long-term treatment for patients with stroke.

This study included 1879 high-risk patients who had a stroke. Participants were assigned to receive either aspirin or clopidogrel alone (group 1; 947 patients) or a combination with cilostazol with aspirin or clopidogrel (group 2; 932 patients). The rate of recurrence (second stroke) and side effects were measured. The average follow-up period was 1.4 years.

A second stroke occurred in 29 (3%) of patients in group 2 and in 64 patients (7%) of group 1. Patients in group 2 had an improvement of 51% in the odds of a better recurrence rate.

Severe bleeding occurred in 8 patients (0.6% per year) from group 2 and in 13 patients (0.9% per year) from group 1. Group 2 had an improvement of 34% in the odds of having a severe bleeding. The occurrence of any other type of side effects was similar in both groups. Gastrointestinal bleeding was the most common type of bleeding.

This study concluded that the combined treatment with cilostazol and aspirin or clopidogrel was associated with a reduced rate of a second stroke. This treatment had a similar risk of severe bleeding compared with aspirin or clopidogrel alone.

The number of participants in this study was lower than initially expected. This might have influenced the results. This study was funded by Otsuka Pharmaceutical, the manufacturer of cilostazol.