Cilostazol in secondary prevention of stroke: impact of the Cilostazol Stroke Prevention Study

Masayasu Matsumoto1

  • 1Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical Sciences, 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan. mack@hiroshima-u.ac.jp

Insights

Cilostazol significantly reduces the risk of recurrent stroke by 41.7% compared to placebo, particularly in patients with lacunar infarction. This antiplatelet drug shows promise for secondary stroke prevention without increasing hemorrhage risk.

Area of Science:

  • Neurology
  • Cardiovascular Medicine
  • Clinical Trials

Background:

  • Stroke is a leading cause of mortality in Japan, necessitating effective secondary prevention strategies.
  • Current secondary stroke prevention involves managing cardiovascular risk factors and using antiplatelet drugs like aspirin and cilostazol.
  • Aspirin, while effective for ischemic strokes, carries an increased risk of hemorrhagic infarction.

Purpose of the Study:

  • To evaluate the efficacy of cilostazol in preventing secondary strokes compared to placebo.
  • To assess the safety profile of cilostazol regarding intracranial hemorrhage.
  • To investigate potential specific effects of cilostazol in patient subgroups, such as those with lacunar infarction.

Main Methods:

  • A randomized, double-blind, placebo-controlled trial (Cilostazol Stroke Prevention Study) involving over 1000 Japanese patients.
  • Comparison of secondary stroke event rates between patients receiving cilostazol and those receiving placebo.
  • Analysis of specific endpoints, including cerebral infarction, intracranial hemorrhage, myocardial infarction, and vascular death.

Main Results:

  • Cilostazol reduced the risk of secondary stroke by 41.7% compared to placebo (P = 0.015).
  • A significant risk reduction of 43.4% was observed in patients with prior lacunar infarction (P = 0.0373), suggesting efficacy against small-vessel disease.
  • Cilostazol demonstrated significant risk reductions in combined vascular endpoints and showed benefits in intent-to-treat analyses without increasing intracranial hemorrhage.

Conclusions:

  • Cilostazol is effective in reducing the risk of secondary stroke, particularly in patients with a history of lacunar infarction.
  • Cilostazol may act as a vascular neuroprotectant with a favorable safety profile concerning intracranial hemorrhage.
  • Clinical implications are tempered by the study's use of placebo instead of aspirin as the comparator, the current standard of care.

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