次级中风预防方面 Cilostazol优于阿斯匹灵


  【24drs.com】March 9, 2010 (圣安东尼奥) — 新研究认为,对于非心脏栓塞脑梗塞病患,在次级中风预防方面,磷酸二酯酶抑制剂cilostazol比阿斯匹灵(ASA)更有效,且严重脑出血的发生率显著较低。
  
  这篇发表于国际中风2010研讨会、最新科学会议中的齐头式试验结果显示,使用cilostazol治疗者发生中风的风险比接受ASA者低25.7%。再者,相较于ASA组,cilostazol组的病患显著较少发生颅内出血(intracerebral hemorrhage,ICH)、蜘蛛膜下出血,或者需要住院的出血。
  
  此外,Shinohara医师表示,cilostazol有更佳的安全资料,中风、暂时性缺血性发作(transient ischemic attack,TIA)、心绞痛、心肌梗塞(myocardial infarction,MI)、心衰竭、需要住院的出血等次级合并终点方面的比率显著较低。
  
  主要研究者、日本东京Tachikawa医院的Yukito Shinohara医师向Medscape Neurology表示,根据这些发现,我们相信,cilostazol应被视为可以耐受长期服用此药之病患的次级中风预防选项之一。
  
  【需要被治疗的病人数目过高、无法接受】
  根据Shinohara医师表示,虽然ASA与其它抗血小板药物如clopidogrel可有效用于次级中风预防,但预防一个事件所需被治疗的病人数目过高,需治疗26-28名病患3年,这令人无法接受,再者,他指出,抗血小板治疗也有明显的出血副作用风险。
  
  Cilostazol的第一篇研究 — 即由Shinohara医师等人10年前在日本进行的「Cilostazol Stroke Prevention Study (CSPS)」研究显示,相较于安慰剂,该药物更有效且出血风险降低。
  
  这促使他们进行目前的CSPS-2研究,将该药和目前用于次级中风预防的照护标准、ASA进行比较。
  
  这项随机、多中心、双盲研究,包括了来自278个中心的2757名非心脏栓塞中风病患,该研究进行期间为2003年12月至2008年12月。
  
  病患被随机分组接受每天两次的cilostazol 100 mg,或者每天一次的ASA 81 mg,治疗期间持续至少1年,至多5年。
  
  【非严重副作用的比率较高】
  该研究的初级终点为发生有症状的中风— 治疗期间脑梗塞、ICH或者蜘蛛膜下出血。
  
  次级终点包括复发有症状的脑梗塞、发生缺血性脑血管事件、任何原因死亡、或发生中风、TIA、心绞痛、MI、心衰竭或者需要住院的出血事件。
  
  Cilostazol组的1,337人,在2965.9人-年中,有82名发生中风,其中2人致命,ASA组的1,335人,在3203.6人-年中,有119人中风,包括3人死亡。
  
  Shinohara医师表示,出血性中风或者需要住院的出血事件,cilostazol组有23名病患发生,ASA组有57人,这是相当大的差异。
  
  虽然cilostazol组的严重副作用比率较低,但是在出血之外的副作用比率比ASA高,例如头痛、腹泻、心悸与晕眩,不过,ASA 组的高血压与便秘比率较高。
  
  【比较便宜,但是不一定比较好】
  Shinohara医师指出,cilostazol比较贵— 费用约是ASA的40倍,他表示,他们目前正进行经济分析与次组分析,希望可以找出最适合这种治疗的对象。
  
  目前,美国核准cilostazol用于治疗间歇性跛行,这是外围动脉疾病患者的主要症状。
  
  阿拉巴马大学附设医院综合中风中心主任Andrei Alexandrov医师受Medscape Neurology之邀对该研究发表评论时表示,cilostazol让医师有另一个可用的治疗选项。
  
  我们需要替代阿斯匹灵主要是因为阿斯匹灵虽可预防中风和心脏病发作,但是它最好吗?答案是否定的,阿斯匹灵虽然便宜,但是便宜不代表更好,阿斯匹灵可预防中风,但有出血风险。
  
  Alexandrov医师表示,我们有clopidogrel和Aggrenox (含有ASA与dipyridamole),但是在一些案例中,你会遇到无法服用这些药物的病患,cilostazol是我们可以用于预防次级中风的另一种武器。
  
  Otsuka Pharmaceutical药厂支持该研究。Shinohara医师报告指出接受Sanofi-Aventis、Mitsubishi Tanabe Pharma、Otsuka Pharmaceutical, Bayer HealthCare、Daiichi-Sankyo与Kyorin Pharmaceutical等药厂的演讲费用与奖金,且担任Otsuka Pharmaceutical药厂咨询委员会的顾问。
  
  国际中风研讨会(ICS)2010:摘要194。发表于2010年2月26日。

Cilostazol Trumps Aspirin in Secondary Stroke Prevention

By Caroline Cassels
Medscape Medical News

March 9, 2010 (San Antonio, Texas) — The phosphodiesterase inhibitor cilostazol is more effective in secondary stroke prevention and has a significantly lower incidence of serious cerebral hemorrhage compared with aspirin (ASA) in patients with noncardioembolic cerebral infarction, new research suggests.

Presented here at a late-breaking scientific session during the International Stroke Conference 2010, the results of the head-to-head trial show that individuals treated with cilostazol were 25.7% less likely to have a stroke than their counterparts who received ASA.

Furthermore, patients in the cilostazol group were significantly less likely to have an intracerebral hemorrhage (ICH), subarachnoid hemorrhage, or hemorrhage requiring hospitalization compared with those in the ASA group.

In addition, said Dr. Shinohara, cilostazol had a superior safety profile, with significantly lower rates on the secondary composite endpoint of stroke, transient ischemic attack (TIA), angina pectoris, myocardial infarction (MI), heart failure, or hemorrhage requiring hospitalization.

"Based on these findings, we believe cilostazol should be considered as a potential treatment option for secondary stroke prevention in patients who can tolerate long-term administration of this drug, " principal investigator Yukito Shinohara, MD, Tachikawa Hospital in Tokyo, Japan, told Medscape Neurology.

Number Needed to Treat Unacceptably High

Dr. Yukito Shinohara

According to Dr. Shinohara, although ASA and other antiplatelet medications, such as clopidogrel, are effective in secondary stroke prevention, the number needed to treat to prevent a single event is unacceptably high — 26 to 28 patients for 3 years. Furthermore, he added, antiplatelet therapy also carries a significant risk for hemorrhagic adverse effects.

The first study of cilostazol — known as the Cilostazol Stroke Prevention Study (CSPS) — conducted by Dr. Shinohara and colleagues in Japan 10 years ago demonstrated that the drug was more effective compared with placebo, with a reduced risk of bleeding.

This led to the current study, the CSPS-2, which pits the drug against ASA, the current standard of care for secondary stroke prevention.

The randomized, multicenter, double-blind, parallel-group study included 2757 noncardioembolic stroke patients from 278 centers. The study took place between December 2003 and December 2008.

Patients randomized to receive cilostazol received 100 mg twice daily, whereas subjects in the ASA group received 81 mg once daily. The duration of treatment lasted a minimum of 1 year and a maximum of 5 years.

Higher Rate of Nonserious Adverse Effects

The study's primary endpoint was occurrence of symptomatic stroke — cerebral infarction, ICH, or subarachnoid hemorrhage during the treatment period.

Secondary endpoints included recurrence of symptomatic cerebral infarction, occurrence of ischemic cerebrovascular event, death from any cause, or cluster of stroke, TIA, angina pectoris, MI, heart failure, or hemorrhage requiring hospitalization.

Stoke occurred in 82 of the 1337 cilostazol-treated patients, and 2 of these events were fatal during 2965.9 person-years. In the 1335 subjects in the ASA group, there were 119 strokes, including 3 deaths, during 3203.6 person-years.

Hemorrhagic stroke or hemorrhage requiring hospitalization occurred in 23 patients in the cilostazol group and 57 in the ASA group — a difference, said Dr. Shinohara, that was highly significant.

Although the rate of serious adverse events was lower in the cilostazol group, the drug fared worse compared with ASA with respect to adverse events other than bleeding, with higher rates of headache, diarrhea, palpitations, and dizziness. However, those in the ASA group had greater rates of hypertension and constipation.

Cheaper, Not Always Better

Dr. Shinohara pointed out that cilostazol is expensive — with a cost that is about 40 times greater than that of ASA. He said his group is currently conducting an economic analysis and subgroup analyses in the hope of characterizing optimal candidates for this treatment.

Currently, cilostazol is approved for use in the United States for the treatment of intermittent claudication, a common concern among patients with peripheral artery disease.

Asked by Medscape Neurology to comment on the study, Andrei Alexandrov, MD, director, Comprehensive Stroke Center, University of Alabama Hospital in Birmingham, said cilostazol may offer clinicians another potential treatment option.

"We need alternatives to aspirin because the main notion is that aspirin protects against stroke and heart attack but is it optimal? The answer is no. Aspirin is cheap, but cheap doesn't mean better. Aspirin protects against stroke, but it carries a risk of bleeding.

"We have clopidogrel and we have Aggrenox (a combination of ASA and dipyridamole), but in certain cases you run up against patients who can't take these, and cilostazol would give us another drug in our arsenal against secondary stroke," said Dr. Alexandrov.

The study was supported by Otsuka Pharmaceutical. Dr. Shinohara reports that he has received speaking fees and honoraria from Sanofi-Aventis, Mitsubishi Tanabe Pharma, Otsuka Pharmaceutical, Bayer HealthCare, Daiichi-Sankyo, and Kyorin Pharmaceutical and has served as a consultant and on the advisory board of Otsuka Pharmaceutical.

International Stroke Conference (ICS) 2010: Abstract 194. Presented February 26, 2010.

    
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