Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital, Tachikawa, Tokyo, Japan.
Lancet Neurol. 2010 Oct;9(10):959-68. doi: 10.1016/S1474-4422(10)70198-8. Epub 2010 Sep 15.
The antiplatelet drug cilostazol is efficacious for prevention of stroke recurrence compared with placebo. We designed the second Cilostazol Stroke Prevention Study (CSPS 2) to establish non-inferiority of cilostazol versus aspirin for prevention of stroke, and to compare the efficacy and safety of cilostazol and aspirin in patients with non-cardioembolic ischaemic stroke.
Patients aged 20-79 years who had had a cerebral infarction within the previous 26 weeks were enrolled at 278 sites in Japan and allocated to receive 100 mg cilostazol twice daily or 81 mg aspirin once daily for 1-5 years. Patients were allocated according to a computer-generated randomisation sequence by means of a dynamic balancing method using patient information obtained at registration. All patients, study personnel, investigators, and the sponsor were masked to treatment allocation. The primary endpoint was the first occurrence of stroke (cerebral infarction, cerebral haemorrhage, or subarachnoid haemorrhage). The predefined margin of non-inferiority was an upper 95% CI limit for the hazard ratio of 1·33. Analyses were by full-analysis set. This trial is registered with ClinicalTrials.gov, number NCT00234065.
Between December, 2003, and October, 2006, 2757 patients were enrolled and randomly allocated to receive cilostazol (n=1379) or aspirin (n=1378), of whom 1337 on cilostazol and 1335 on aspirin were included in analyses; mean follow-up was 29 months (SD 16). The primary endpoint occurred at yearly rates of 2·76% (n=82) in the cilostazol group and 3·71% (n=119) in the aspirin group (hazard ratio 0·743, 95% CI 0·564-0·981; p=0·0357). Haemorrhagic events (cerebral haemorrhage, subarachnoid haemorrhage, or haemorrhage requiring hospital admission) occurred in fewer patients on cilostazol (0·77%, n=23) than on aspirin (1·78%, n=57; 0·458, 0·296-0·711; p=0·0004), but headache, diarrhoea, palpitation, dizziness, and tachycardia were more frequent in the cilostazol group than in the aspirin group.
Cilostazol seems to be non-inferior, and might be superior, to aspirin for prevention of stroke after an ischaemic stroke, and was associated with fewer haemorrhagic events. Therefore, cilostazol could be used for prevention of stroke in patients with non-cardioembolic stroke.
Otsuka Pharmaceutical.
与安慰剂相比，抗血小板药物西洛他唑在预防中风复发方面更有效。我们设计了第二个西洛他唑预防中风研究（CSPS 2），以确定西洛他唑与阿司匹林预防中风的非劣效性，并比较西洛他唑和阿司匹林在非心源性缺血性中风患者中的疗效和安全性。
在日本的 278 个地点招募了年龄在 20-79 岁之间、在过去 26 周内发生过脑梗死的患者，并将其分配接受每天两次 100mg 西洛他唑或每天一次 81mg 阿司匹林治疗 1-5 年。患者根据计算机生成的随机化序列，通过在注册时获得的患者信息使用动态平衡方法进行分组。所有患者、研究人员、研究者和赞助商均对治疗分配情况进行了屏蔽。主要终点是首次发生中风（脑梗死、脑出血或蛛网膜下腔出血）。非劣效性的预设上限 95%CI 限制为危险比的 1.33。分析采用全分析集。该试验在 ClinicalTrials.gov 注册，编号为 NCT00234065。
2003 年 12 月至 2006 年 10 月，共纳入 2757 例患者并随机分配接受西洛他唑（n=1379）或阿司匹林（n=1378）治疗，其中 1337 例接受西洛他唑治疗，1335 例接受阿司匹林治疗；中位随访时间为 29 个月（SD 16）。西洛他唑组的主要终点年发生率为 2.76%（n=82），阿司匹林组为 3.71%（n=119）（危险比 0.743，95%CI 0.564-0.981；p=0.0357）。西洛他唑组（0.77%，n=23）出血事件（脑出血、蛛网膜下腔出血或需要住院治疗的出血）少于阿司匹林组（1.78%，n=57）（0.458，0.296-0.711；p=0.0004），但西洛他唑组头痛、腹泻、心悸、头晕和心动过速的发生率高于阿司匹林组。
西洛他唑似乎在预防缺血性中风后的中风方面不劣于阿司匹林，而且可能优于阿司匹林，并且与较少的出血事件相关。因此，西洛他唑可用于预防非心源性中风患者的中风。
大冢制药。
