ESPRIT study design and outcomes – a critical appraisal

• Published in: Current medical research and opinion Vol. 23; no. 2; pp. 271 - 273
• Main Author: Einhäupl, Karl
• Format: Journal Article
• Language: English
• Published: England Informa UK Ltd 01.02.2007; Taylor & Francis; Informa Healthcare
• Subjects: Aspirin; Aspirin - administration & dosage; Aspirin - adverse effects; Aspirin - therapeutic use; Biomarkers; Brain Ischemia - epidemiology; Brain Ischemia - prevention & control; Dipyridamole; Dipyridamole - administration & dosage; Dipyridamole - adverse effects; Dipyridamole - therapeutic use; Drug Therapy, Combination; Fibrinolytic Agents - administration & dosage; Fibrinolytic Agents - adverse effects; Fibrinolytic Agents - therapeutic use; Hemorrhage - chemically induced; Hemorrhage - epidemiology; Humans; Ischaemic stroke; Methodological issues; Myocardial Infarction - epidemiology; Myocardial Infarction - prevention & control; Outcome study; Patient Dropouts - statistics & numerical data; Prospective Studies; Research Design; Secondary prevention; Stroke - epidemiology; Stroke - prevention & control; Treatment Outcome; Vascular Diseases - mortality
• ISSN: 0300-7995; 1473-4877
• DOI: 10.1185/030079906X167291

ABSTRACT Evidence is needed to guide therapeutic decisions on patients who had ischaemic cerebral events. The recently published European/Australasian Stroke Prevention in Reversible Ischaemia Trial (ESPRIT), an open-label randomised controlled study, compared long-term treatment of patients randomised to aspirin 30–325 mg daily with (n = 1363) or without (n = 1376) dipyridamole 200 mg twice daily. The study found the combination to be superior to aspirin alone (13% vs. 16% events in a composite endpoint of vascular death, non-fatal stroke, non-fatal myocardial infarction, or major bleeding; hazard ratio 0.8; 95% confidence interval 0.66–0.98). In the interpretation of the results, criticism has been raised related to the study design (open-label, change during the study), the study conduct (half of the aspirin patients underdosed, 33% drop-out rate in the combination group, missing information on potential confounders such as protective concomitant medication), and the outcomes (lack of differences in the efficacy outcomes between the intent-to-treat and the on-treatment populations, lack of differences in minor bleedings between treatment groups, borderline statistical significance of primary study endpoint). Further studies are needed to determine the place of aspirin/dipyridamole combinations in the secondary prevention of stroke.