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| ESPRIT results confirm first-line status of ER-Dipyridamole (ER-DP) + Aspirin (ASA) |
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19 May 2006
Impressive positive results from ESPRIT (European/Australasian Stroke Prevention in Reversible Ischaemia Trial) provide further compelling evidence that, for secondary prevention of stroke, the combination of dipyridamole and aspirin is superior to aspirin alone. ESPS-2 showed that the combination of extended-release dipyridamole and aspirin prevents more major vascular events than does aspirin alone (relative risk reduction 22% for the endpoint of all major vascular events). ESPRIT has shown a 20% relative risk reduction in the comparison of dipyridamole and aspirin with aspirin alone for the composite endpoint (see below). The majority of patients (83%) used extended-release dipyridamole. These new results provide solid confirmation of the ESPS-2 findings.
ESPRIT compared the combination of aspirin and dipyridamole with aspirin for the prevention of vascular events; its other aim was to compare anticoagulation with a low INR (2.0–3.0) with aspirin for secondary prevention but this part of the study is not yet complete. The study was entirely independent of pharmaceutical companies, being funded by governmental and charitable organisations.
Patients with a TIA or minor ischaemic stroke (Rankin grade =3) were randomised between the combination of dipyridamole (400 mg daily) plus aspirin (any dose within 30–325 mg/day) and aspirin alone (30–325 mg/day). Treatment was open but outcome assessment was blinded. The primary outcome was the composite event death from all vascular causes, non-fatal stroke, non-fatal myocardial infarction or major bleeding complication, whichever occurs first.
More than 1,300 patients were randomised to each treatment arm and mean follow-up was 3.5 years. The median aspirin dose was 75 mg in both groups.
Primary outcome events (combined endpoint) occurred in 173 (13%) of patients allocated to the combination and in 216 (16%) of those on aspirin; the resulting hazard ratio was 0.80 (95% CI 0.66–0.98). Thus the relative risk reduction with the combination for this event was 20%.
Adding the ESPRIT data to the meta-analysis of previous trials (ESPS-2 and four earlier studies) gave an overall risk ratio for the composite endpoint of vascular death, stroke or myocardial infarction of 0.82 (95%CI 0.74–0.91). The investigators concluded that the results provided sufficient evidence to prefer the combination of dipyridamole and aspirin as antithrombotic therapy after cerebral ischaemia of arterial origin.
Patients on combination treatment discontinued trial medication more often that those on aspirin (34% (470) vs. 13% (184)) mainly because of adverse events, most commonly headaches.
Reference:
ESPRIT Study Group. Lancet 2006; 367 (9523): 1665-1673.
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