Doctor's Guide
Treatment with the phosphodiesterase inhibitor cilostazol proved superior to aspirin therapy in preventing stroke recurrence among patients with noncardioembolic cerebral infarction, researchers said here at the 2010 International Stroke Conference (ISC).
The study was designed to prove that cilostazol was noninferior to aspirin, but, in fact, the researchers said that treatment cilostazol was statistically superior to aspirin.
"We therefore recommend cilostazol as an option for the prevention of stroke reoccurrence in noncardioembolic stroke patients who can tolerate long-term administration of this drug," said Yukito Shinohara, MD, Department of Neurology, Tachikawa Hospital, Tokyo, Japan, during his poster presentation on February 26.
For the study, researchers from 279 institutes enrolled 2,757 individuals between December 2003 and October 2006. Eventually, 2,716 of these patients received the study medication and 2,681 were included in the safety and efficacy analysis.
Patients had suffered cerebral infarction within 26 weeks prior to enrolment and symptoms had remained stable. They were randomised in a double-blinded design to receive either cilostazol 100 mg BID or aspirin 81 mg once daily.
The primary endpoint was occurrence of stroke (a cerebral infarction, cerebral haemorrhage, or subarachnoid haemorrhage).
Stroke occurred in 82 of the 1,337 patients in the cilostazol group during 2,965.9 person-years. Two of those strokes were fatal. Stroke occurred in 119 of the 1,335 patients in the aspirin group during 3,203.6 person-years. Three of those events were fatal.
Dr. Shinohara said the treatment with cilostazol reduced the risk of suffering a stroke by about 26%. "These results establish noninferiority of cilostazol to aspirin for secondary prevention of stroke," he said. "In addition, time from start of administration to occurrence of stroke was significantly longer [P = .0357] in the cilostazol group."
In safety assessment, intracerebral haemorrhage and other brain bleeds occurred more often with cilostazol. Dr. Shinohara said 23 of the 1,337 patients randomised to cilostazol experienced these adverse events compared with 57 of the 1,335 patients randomised to aspirin (P = .0004).
He also said that headache, diarrhoea, palpitations, dizziness, tachycardia, hypertension, and constipation all appeared to occur more frequently in the patients taking cilostazol.
Funding for this study was provided by Otsuka Pharma Ltd.
The study was designed to prove that cilostazol was noninferior to aspirin, but, in fact, the researchers said that treatment cilostazol was statistically superior to aspirin.
"We therefore recommend cilostazol as an option for the prevention of stroke reoccurrence in noncardioembolic stroke patients who can tolerate long-term administration of this drug," said Yukito Shinohara, MD, Department of Neurology, Tachikawa Hospital, Tokyo, Japan, during his poster presentation on February 26.
For the study, researchers from 279 institutes enrolled 2,757 individuals between December 2003 and October 2006. Eventually, 2,716 of these patients received the study medication and 2,681 were included in the safety and efficacy analysis.
Patients had suffered cerebral infarction within 26 weeks prior to enrolment and symptoms had remained stable. They were randomised in a double-blinded design to receive either cilostazol 100 mg BID or aspirin 81 mg once daily.
The primary endpoint was occurrence of stroke (a cerebral infarction, cerebral haemorrhage, or subarachnoid haemorrhage).
Stroke occurred in 82 of the 1,337 patients in the cilostazol group during 2,965.9 person-years. Two of those strokes were fatal. Stroke occurred in 119 of the 1,335 patients in the aspirin group during 3,203.6 person-years. Three of those events were fatal.
Dr. Shinohara said the treatment with cilostazol reduced the risk of suffering a stroke by about 26%. "These results establish noninferiority of cilostazol to aspirin for secondary prevention of stroke," he said. "In addition, time from start of administration to occurrence of stroke was significantly longer [P = .0357] in the cilostazol group."
In safety assessment, intracerebral haemorrhage and other brain bleeds occurred more often with cilostazol. Dr. Shinohara said 23 of the 1,337 patients randomised to cilostazol experienced these adverse events compared with 57 of the 1,335 patients randomised to aspirin (P = .0004).
He also said that headache, diarrhoea, palpitations, dizziness, tachycardia, hypertension, and constipation all appeared to occur more frequently in the patients taking cilostazol.
Funding for this study was provided by Otsuka Pharma Ltd.
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