According to recent epidemiological data in Japan,
stroke affects roughly 5.3 males and 3.9 females per 1000 person-years and is the third leading cause of mortality. At present, management strategies for
secondary prevention of
stroke include aggressive treatment of cardiovascular risk factors (i.e.,
hypertension, smoking cessation, etc.).
Antiplatelet drugs in Japan, namely
aspirin and
cilostazol, are utilized regularly for the prevention of secondary
stroke. While
aspirin is beneficial for a wide range of cardiovascular endpoints, including total and
ischemic strokes, it is also associated with significantly increased risks for hemorrhagic
infarction.
Cilostazol, by contrast, has been shown to significantly reduce the risk of recurrent
strokes without affecting the occurrence of
intracranial hemorrhage. In the
Cilostazol Stroke Prevention Study, a randomized double-blind, placebo-controlled trial involving more than 1000 Japanese patients,
cilostazol was found to reduce the risk of secondary
stroke by 41.7% compared with placebo, a statistically significant reduction (P = 0.015). The greatest risk reduction (43.4% in
cilostazol versus placebo, P = 0.0373) was found in patients who initially had a
lacunar infarction, suggesting that
cilostazol has a specific effect against small-vessel disease. In addition,
cilostazol achieved significant risk reductions on a number of combined endpoints (e.g.,
cerebral infarction,
intracranial hemorrhage,
myocardial infarction, or vascular death), and was associated with benefits in intent-to-treat analyses. These findings indicate that
cilostazol may have a role as a vascular
neuroprotectant, but the clinical implications are limited by the fact that patients were randomized to placebo instead of
aspirin, which is the standard of care.