[Dipyridamole and aspirin for secondary prevention after stroke or TIA]
Record ID 32011000953
The aim of this research was to assess the benefit of treatment with the combination of the two agents dipyridamole plus ASA as secondary prevention after an ischaemic stroke or TIA. This combination therapy was compared to other drug interventions or placebo on the basis of patient-relevant outcomes.
There is an indication of a benefit of combination therapy with dipyridamole + ASA in respect of prevention of non-fatal strokes and TIAs in long-term (at least 12 months) treatment. There is no proof that combination therapy reduces mortality. This indication of a benefit is accompanied by indications of harm due to major and minor bleeding, study discontinuations due to AEs, and overall AEs.There is no proof that combination therapy with dipyridamole + ASA has an additional benefit versus monotherapy with a thrombocyte aggregation inhibitor (ASA or clopidogrel). In this context there is no evidence that this conclusion differs if ASA or clopidogrel alone are assessed as comparator therapy. The lack of an additional benefit is accompanied by proof of greater harm with combination therapy. This greater harm is particularly due to the more frequent occurrence of major bleeding in long-term therapy. This is the result of a primarily medically founded summarizing assessment of dipyridamole + ASA versus the (pooled) controls ASA and clopidogrel. In both cases, a separate comparison with each control produced statistically non-significant results to the (numerical) disadvantage of combination therapy, which, however, became statistically significant in the pooling of the (non-heterogeneous) data.In addition, patients under 65 years of age experienced more intracranial bleeding events (versus clopidogrel). The data do not provide proof that other SAEs occur more often with dipyridamole + ASA than with ASA or clopidogrel. In addition, the data provide an indication (in short-term therapy) and proof (in long-term therapy) that study discontinuations due to AEs are more common with combination therapy.
English language abstract:
An English language summary is available
- Ischemic Attack, Transient
- Secondary Prevention
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Institut fuer Qualitaet und Wirtschaftlichkeit im Gesundheitswesen (IQWiG)