ESPRIT (study)
ESPRIT is the acronym of a study published in The Lancet in May 2006 on the effectiveness of the drug dipyridamole in preventing strokes and other embolisms in patients after transient ischemic attacks (TIA) and minor strokes . With regard to the selected primary endpoint , the study found that dipyridamole was superior to its effectiveness when administered in addition to acetylsalicylic acid (ASA).
Inclusion criteria and study design
A total of 2763 patients with a TIA or a minor stroke presumably of arterial origin in the last six months were all given 30–325 mg (median 75 mg) ASA daily and were randomized to receive 200 mg dipyridamole twice daily (n = 1363, "verum group") ) or treated without additional dipyridamole (n = 1376, “control group”). 83% of the dipyridamole patients received a retarded preparation. The treatment was open, the evaluation of the endpoints blinded.
Results
After an average of 3.5 years, significantly more patients in the verum group had stopped the study medication than in the control group (470 versus 184), mainly because of headaches. The primary endpoint of the study ( stroke , myocardial infarction , serious bleeding complication or death from vascular cause) occurred 173 times (13%) with dipyridamole and 216 times (16%) without dipyridamole. The difference with a relative risk reduction of 20% ( hazard ratio 0.80; 95% - confidence interval 0.66–0.98) and an absolute risk reduction of 1% per year was statistically slightly significant .
The secondary endpoint “death from all causes” occurred 93 times in the verum group and 107 times in the control group; this difference ( hazard ratio 0.88; 95% confidence interval 0.67–1.17) was not statistically significant.
34% of the patients in the dipyridamole ASA group and 13% of the patients in the ASA group stopped treatment prematurely. Headache is very common with dipyridamole.
The meaningfulness of the results is controversial in view of the open design, the high discontinuation rate under the combination treatment, the inconsistency of the results and the largely inadequate ASA dosage.
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- ^ ESPRIT Study Group; Halkes PH et al .: Aspirin plus dipyridamole versus aspirin alone after cerebral ischaemia of arterial origin (ESPRIT): randomized controlled trial . Lancet (2006) 367: 1665-1673. PMID 16714187 .
- ↑ at 2006; 37: 55-6