Q J Med 2003; 96: 155-160
© 2003 Association of Physicians
Commentary |
Superiority and equivalence in thrombolytic drugs: an interpretation
From the Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK
| The first 150 words of the full text of this article appear below. |
| Introduction |
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Streptokinase and alteplase both reduce mortality from acute myocardial infarction. Newer thrombolytic drugs (reteplase and tenecteplase) have putative advantages, such as ease of delivery and better fibrin specificity, although they are more expensive. A systematic review and meta-analysis identified the clinical efficacy and adverse effects of these drugs.1 But this can only compare drugs where there are direct trial comparisons. Inevitably, we need to make indirect comparisons also, as well as to interpret the results of the direct comparisons. We present an interpretation and consider its strengths and weaknesses.
| Equivalence and superiority in clinical trials |
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Broadly, superiority studies, where one drug is thought likely to be better than another, assume a null hypothesis that there is no difference, which may then be disproved. Such studies are usually analysed by intention to treat (ITT, i.e. to analyse all patients according to their initial randomized allocation, and not whether they ever received the therapy or changed at some
| Analysing equivalence trials |
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| Direct comparisons between drugs |
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Alteplase and streptokinase
Alteplase and reteplase
Reteplase and streptokinase
Alteplase and tenecteplase
| Indirect comparisons |
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Streptokinase vs. tenecteplase
Reteplase vs. tenecteplase
| Bleeding and adverse events |
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| Discussion |
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