Journal
STROKE
Volume 52, Issue 10, Pages E635-E645Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1161/STROKEAHA.121.035002
Keywords
aspirin; brain ischemia; follow-up studies; headache; humans
Categories
Funding
- National Institutes of Health (NIH)-National Institute of Neurological Disorders and Stroke (NINDS) [K23NS105924]
- NIH-NCATS [UL1TR003015, KL2TR00316]
- NIH-NINDS [U01 NS086872, U01NS106513, R01NS11072, R01NR018335, R03NS112859, U24NS107215, U24NS107136]
- American Heart Association [17CSA33550004]
- Japan Agency for Medical Research and Development [20lk0201094h0002, 20lk0201109h0001]
- UK Dementia Research Institute by UK Medical Research Council
- UK Dementia Research Institute by Alzheimer's Research UK
- UK Dementia Research Institute by Alzheimer's Society
- Fondation Leducq [16 CVD 05]
- National Center for Advancing Translational Sciences of the National Institutes of Health [UL1TR002538]
- MRC [UKDRI-4002] Funding Source: UKRI
Ask authors/readers for more resources
Cilostazol is a safe drug approved for the treatment of claudication in peripheral arterial disease patients and secondary stroke prevention in Asian countries. While it reduces the risk of stroke recurrence in noncardioembolic stroke patients, it may cause adverse effects such as headache, gastrointestinal symptoms, and palpitations.
Cilostazol is a PDE3 (phosphodiesterase III) inhibitor with a long track record of safety that is Food and Drug Administration and European Medicines Agency approved for the treatment of claudication in patients with peripheral arterial disease. In addition, cilostazol has been approved for secondary stroke prevention in several Asian countries based on trials that have demonstrated a reduction in stroke recurrence among patients with noncardioembolic stroke. The onset of benefit appears after 60 to 90 days of treatment, which is consistent with cilostazol's pleiotropic effects on platelet aggregation, vascular remodeling, blood flow, and plasma lipids. Cilostazol appears safe and does not increase the risk of major bleeding when given alone or in combination with aspirin or clopidogrel. Adverse effects such as headache, gastrointestinal symptoms, and palpitations, however, contributed to a 6% increase in drug discontinuation among patients randomized to cilostazol in a large secondary stroke prevention trial ([Cilostazol Stroke Prevention Study for Antiplatelet Combination]). Due to limitations of prior trials, such as open-label design, premature trial termination, large loss to follow-up, lack of functional or cognitive outcome data, and exclusive enrollment in Asia, the existing trials have not led to a change in clinical practice or guidelines in Western countries. These limitations could be addressed by a double-blind placebo-controlled randomized trial conducted in a broader population. If positive, it would increase the evidence in support of long-term treatment with cilostazol for secondary prevention in the millions of patients worldwide who have experienced a noncardioembolic ischemic stroke.
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