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ESC: Terutroban Not Superior for Preventing Strokes

Last Updated: May 25, 2011.

Terutroban is neither superior to nor safer than aspirin in preventing cerebral and cardiovascular events in patients with a recent ischemic stroke or transient ischemic attack, according to a study published online May 25 in The Lancet to coincide with a presentation at the European Stroke Conference, held from May 24 to 27 in Hamburg, Germany.

WEDNESDAY, May 25 (HealthDay News) -- Terutroban is neither superior to nor safer than aspirin in preventing cerebral and cardiovascular events in patients with a recent ischemic stroke or transient ischemic attack (TIA), according to a study published online May 25 in The Lancet to coincide with a presentation at the European Stroke Conference, held from May 24 to 27 in Hamburg, Germany.

Marie-Germaine Bousser, M.D., from Paris-Diderot University, and colleagues compared the effectiveness of terutroban to aspirin in the prevention of cerebral and cardiovascular ischemic events in patients presenting within three months of an ischemic stroke or eight days of a TIA. A total of 9,562 patients were randomized to receive 30 mg per day of terutroban (9,556 were analyzed), and 9,558 received 100 mg per day of aspirin (9,544 were analyzed). During an average follow-up of 28.3 months, the composite of fatal or non-fatal ischemic strokes and myocardial infarctions, or other vascular deaths (excluding hemorrhagic death) were the main outcomes studied. A non-inferiority analysis (margin 1.05) was performed, followed by a superiority analysis. The study was stopped prematurely due to ineffectiveness of the treatment.

The investigators identified the primary end point in 1,091 patients receiving terutroban, and in 1,062 receiving aspirin (hazard ratio [HR], 1.02; 95 percent confidence interval 0.94 to 1.12). No difference was identified between terutroban and aspirin in the secondary or tertiary end points. Participants on terutroban showed some increase in minor bleedings compared to those on aspirin (HR, 1.11), with no significant differences for other safety end points.

"The trial did not meet the predefined criteria for non-inferiority, but showed similar rates of the primary end point with terutroban and aspirin, without safety advantages for terutroban," the authors write.

Several authors disclosed financial relationships with pharmaceutical companies, including Servier, which funded the study.

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