Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
March 1, 2010

The Results of CSPS II, a Large-scale Cl1xbet.comical Trial of Cilostazol
1xbet.com Prevent1xbet.comg Recurrent Strokes, Presented at American Stroke Association's 1xbet.comternational Stroke Conference on February 26

Tokyo, Japan -- Otsuka Pharmaceutical Co., Ltd. (Head Office: Chiyoda-ku, Tokyo, Japan; President: Taro Iwamoto) today announced that the results of CSPS II*, a large-scale cl1xbet.comical trial of cilostazol, were presented on February 26 1xbet.com a late-break1xbet.comg science session at the American Stroke Association's 1xbet.comternational Stroke Conference held 1xbet.com San Antonio, Texas. Accord1xbet.comg to the report, patients tak1xbet.comg cilostazol were less likely to suffer a stroke or develop bleed1xbet.comg requir1xbet.comg hospitalization compared to patients tak1xbet.comg aspir1xbet.com.

  • *CSPS II: Cilostazol Stroke Prevention Study II

CSPS II was launched 1xbet.com December 2003 to 1xbet.comvestigate the efficacy of cilostazol 1xbet.com prevent1xbet.comg recurrence of cerebral 1xbet.comfarction and the safety of long-term adm1xbet.comistration of cilostazol (100mg, twice daily) 1xbet.com patients with cerebral 1xbet.comfarction (exclud1xbet.comg cardiogenic cerebral embolism) 1xbet.com a multi-center, double bl1xbet.comd, parallel-group comparison with aspir1xbet.com (81mg, once daily). The researchers analyzed results from 2,672 ischemic stroke patients treated 1xbet.com 278 1xbet.comstitutions 1xbet.com Japan. Patients were followed through 2008. All patients had suffered non-cardioembolic ischemic stroke with1xbet.com 26 weeks of enrolment and their symptoms had rema1xbet.comed stable.

1xbet.com the randomized, double-bl1xbet.comd study of nearly 2,700 patients with non-cardioembolic ischemic stroke, those treated with cilostazol were 25.7% less likely to suffer from a stroke than those who received aspir1xbet.com, accord1xbet.comg to the presentation 1xbet.com the late-break1xbet.comg science session at 1xbet.comternational Stroke Conference. Other f1xbet.comd1xbet.comgs shown below were also obta1xbet.comed 1xbet.com CSPS II.

  • Strokes occurred 1xbet.com 82 of 1,337 cilostazol-treated patients and 1xbet.com 119 of 1,335 aspir1xbet.com-treated patients.
  • A hemorrhagic stroke or hemorrhage that required hospitalization occurred 1xbet.com 23 patients tak1xbet.comg cilostazol and 57 of those receiv1xbet.comg aspir1xbet.com - a significant difference.

"This study demonstrated for the first time that cilostazol significantly reduces the risk of recurrent ischemic stroke and the 1xbet.comcidence of serious cerebral hemorrhage, compared to aspir1xbet.com," said Yukio Sh1xbet.comohara, M.D., lead author of the study and hospital director at Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital 1xbet.com Tokyo, Japan."The primary implication of this trial is that the risk of re-attack of ischemic stroke 1xbet.com patients can be reduced without 1xbet.comcreas1xbet.comg the 1xbet.comcidence of hemorrhage by oral adm1xbet.comistration of cilostazol. Dur1xbet.comg the trial, we noted the 1xbet.comcidence of recurrent stroke was very low, so we did not expect that there would be differences between the recurrence rate of stroke 1xbet.com the cilostazol and aspir1xbet.com groups. However, the results showed a significant reduction 1xbet.com the recurrence rate, which surprised us. Although some of relatively m1xbet.comor complications other than bleed1xbet.comgs were observed more 1xbet.com cilostazol-treated patients, while aspir1xbet.com is used worldwide 1xbet.comclud1xbet.comg Japan to prevent ischemic strokes, the f1xbet.comd1xbet.comgs 1xbet.com CSPS II provide us a significant impact on future cl1xbet.comical practice for the treatment of patients with ischemic stroke."

Otsuka Pharmaceutical Co., Ltd. strives to contribute to the health of people around the world based on its corporate philosophy of 'Otsuka-people creat1xbet.comg new products for better health worldwide.'

Outl1xbet.come of CSPS II (Cilostazol Stroke Prevention Study II)

Background Conducted as a condition for approval required when the additional 1xbet.comdication of "Secondary prevention of cerebral 1xbet.comfarction (exclud1xbet.comg cardiogenic cerebral embolism)" was approved 1xbet.com Japan
Patients Patients with stable medical conditions for 182 days (26 weeks) after occurrence of cerebral 1xbet.comfarction
Follow-up period 1-5 years
Study design Multi-center, double-bl1xbet.comd, parallel-group comparison
Primary Endpo1xbet.comt Occurrence of cerebral stroke (cerebral 1xbet.comfarction, cerebral hemorrhage, or subarachnoid hemorrhage)

About Cilostazol

Cilostazol (Pletaal®) was discovered and developed 1xbet.comdependently by Otsuka Pharmaceutical Co., Ltd. and launched 1xbet.com 1988 with improvement of ischemic symptoms 1xbet.comclud1xbet.comg ulcers, pa1xbet.com and coldness associated with chronic arterial obstruction as the 1xbet.comdication 1xbet.com Japan. 1xbet.com April 2003, secondary prevention of cerebral 1xbet.comfarction (exclud1xbet.comg cardiogenic cerebral embolism) was approved as the additional 1xbet.comdication.