Aspirin/Dipyridamole Has Similar Effects on Acute Mild Stroke Versus Clopidogrel: Presented at ISC
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Aspirin/Dipyridamole Has Similar Effects on Acute Mild Stroke Versus Clopidogrel: Presented at ISC

By Ed Susman

SAN ANTONIO, Tex -- February 26, 2010 -- Patients with acute mild ischaemic stroke did not achieve better outcome if they were treated with aspirin/dipyridamole or clopidogrel, researchers said here at the 2010 International Stroke Conference (ISC).

The researchers reviewed data from the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) study, looking for evidence of a difference between the treatments in functional outcome or the prevention of second strokes. PRoFESS failed to meet its primary endpoint of showing that the combination product was noninferior to clopidogrel.

“Treatment with combined aspirin/dipyridamole versus clopidogrel in 1,360 patients with acute mild ischaemic stroke did not differ in effects on functional outcome, death, bleeding, or serious adverse events,” said Philip Bath, MD, University of Nottingham, Nottingham, United Kingdom, during his poster presentation on February 24.

In the study, researchers enrolled 20,332 patients to assess antiplatelet and blood pressure-lowering strategies for secondary prevention of stroke. Of that group, 672 patients were randomised within 72 hours of ischaemic stroke symptoms to the combination of aspirin 25 mg twice a day and extended-release dipyridamole 200 mg twice a day. Another 688 patients were assigned to receive clopidogrel 75 mg/day.

In the subgroup analysis, the primary outcome was functional outcome at 30 days; secondary outcomes included recurrence and death at up to 90 days. Analyses were adjusted for baseline prognostic variables and blood pressure treatment assignment, Dr. Bath said. The average age of the patients in the substudy was 67 years, and the average National Institutes of Health Stroke Scale score was 3, indicating mild residual symptoms from the cerebrovascular event.

When the researchers scrutinised outcomes, the risk of dying or becoming dependent upon others to complete the activities of daily living did not differ between the 2 groups (P = .75). Patients taking aspirin and dipyridamole had a 44% reduction in recurrence and a 29% decrease in recurrence of vascular events, but neither of the differences achieved statistical significance, Dr. Bath said.

“Administration of both treatments was practical and well tolerated,” he said.

Funding for this study was provided by Boehringer Ingelheim.

[Presentation Title: Effect of Combined Aspirin and Extended-Release Dipyridamole Versus Clopidogrel on Functional Outcome and Recurrence in Patients With Acute Ischaemic Stroke: A PRoFESS Subgroup Analysis. Abstract P30]

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