Wednesday, November 10, 2010
aspirin
4.
Cilostazol vs. Aspirin for Recurrent-Stroke Prevention
In a large, long-term trial, cilostazol was as effective as aspirin at preventing recurrent stroke and was associated with fewer hemorrhages.
Antiplatelet drugs have an established role in secondary stroke prevention. Several attempts have been made to boost the clinical effectiveness of these treatments by enhancing antithrombotic effects or lowering hemorrhagic risks. Cilostazol, a drug that primarily acts by inhibiting phosphodiesterase and, thus, platelet aggregation, is more effective than placebo at preventing stroke recurrence but has not been tested against routinely prescribed antiplatelet agents.
The manufacturer-funded second Cilostazol Stroke Prevention Study (CSPS 2) was designed to establish clinical noninferiority of cilostazol versus aspirin for the prevention of recurrent stroke in patients with noncardioembolic stroke. At multiple sites in Japan, the investigators enrolled 2757 people aged 20 to 79 who had experienced a cerebral infarction within the previous 6 months. Participants were randomized to receive cilostazol (100 mg twice daily) or aspirin (81 mg once daily) for 1 to 5 years. The primary endpoint was the first occurrence of any stroke.
About three quarters of the participants were men; mean follow-up was 29 months. The primary endpoint occurred significantly less frequently with cilostazol than with aspirin (hazard ratio, 0.74; 95% confidence interval, 0.56–0.98). Hemorrhagic events (cerebral hemorrhage, subarachnoid hemorrhage, or hemorrhage requiring hospital admission) happened in significantly fewer patients in the cilostazol group than in the aspirin group (0.77% vs. 1.78%), but headache, diarrhea, palpitations, dizziness, and tachycardia were significantly more common with cilostazol.
Comment: The notion that, compared with aspirin, a drug with primarily antiplatelet actions could lower both stroke risk and bleeding events is highly appealing. However, we need evidence establishing cilostazol's superiority over aspirin in a more heterogeneous cohort (specifically with more non-Asians and women). Also, given the drug's cost, twice-daily dosing, and adverse effects, showing just "me-too" efficacy may not be enough; an absolute stroke risk reduction of at least 1% per year compared with aspirin may be necessary to convince skeptical clinicians of its clinical utility and cost-effectiveness. Such a future trial could also allow investigation of whether switching antiplatelet therapy in the oft-encountered patient who has experienced a stroke while on aspirin (i.e., with aspirin failure) is clinically worthwhile.
— Bruce Ovbiagele, MD, MS, FAHA
Published in Journal Watch Neurology October 26, 2010
Cilostazol vs. Aspirin for Recurrent-Stroke Prevention
In a large, long-term trial, cilostazol was as effective as aspirin at preventing recurrent stroke and was associated with fewer hemorrhages.
Antiplatelet drugs have an established role in secondary stroke prevention. Several attempts have been made to boost the clinical effectiveness of these treatments by enhancing antithrombotic effects or lowering hemorrhagic risks. Cilostazol, a drug that primarily acts by inhibiting phosphodiesterase and, thus, platelet aggregation, is more effective than placebo at preventing stroke recurrence but has not been tested against routinely prescribed antiplatelet agents.
The manufacturer-funded second Cilostazol Stroke Prevention Study (CSPS 2) was designed to establish clinical noninferiority of cilostazol versus aspirin for the prevention of recurrent stroke in patients with noncardioembolic stroke. At multiple sites in Japan, the investigators enrolled 2757 people aged 20 to 79 who had experienced a cerebral infarction within the previous 6 months. Participants were randomized to receive cilostazol (100 mg twice daily) or aspirin (81 mg once daily) for 1 to 5 years. The primary endpoint was the first occurrence of any stroke.
About three quarters of the participants were men; mean follow-up was 29 months. The primary endpoint occurred significantly less frequently with cilostazol than with aspirin (hazard ratio, 0.74; 95% confidence interval, 0.56–0.98). Hemorrhagic events (cerebral hemorrhage, subarachnoid hemorrhage, or hemorrhage requiring hospital admission) happened in significantly fewer patients in the cilostazol group than in the aspirin group (0.77% vs. 1.78%), but headache, diarrhea, palpitations, dizziness, and tachycardia were significantly more common with cilostazol.
Comment: The notion that, compared with aspirin, a drug with primarily antiplatelet actions could lower both stroke risk and bleeding events is highly appealing. However, we need evidence establishing cilostazol's superiority over aspirin in a more heterogeneous cohort (specifically with more non-Asians and women). Also, given the drug's cost, twice-daily dosing, and adverse effects, showing just "me-too" efficacy may not be enough; an absolute stroke risk reduction of at least 1% per year compared with aspirin may be necessary to convince skeptical clinicians of its clinical utility and cost-effectiveness. Such a future trial could also allow investigation of whether switching antiplatelet therapy in the oft-encountered patient who has experienced a stroke while on aspirin (i.e., with aspirin failure) is clinically worthwhile.
— Bruce Ovbiagele, MD, MS, FAHA
Published in Journal Watch Neurology October 26, 2010
# posted by roodbont @ 1:32 AM 
