Key result
rt-PA approval for acute myocardial infarction was recommended for delay by the FDA Advisory Panel due to inadequate data on clinical benefit, safety, and optimal therapeutic regimen.
Why the study?
Does rt-PA provide superior clinical benefit and safety compared to streptokinase in patients with acute myocardial infarction?
Does rt-PA provide superior clinical benefit and safety compared to streptokinase in patients with acute myocardial infarction?
The editorial highlights the rationale behind the FDA's 1987 decision to delay rt-PA approval, emphasizing the need for robust data on clinical benefit, safety, and optimal dosing compared to streptokinase.
Considerable dissatisfaction has been expressed over the FDA's Cardio-renal Advisory Panel's recommendation on May 29, 1987 that approval of rt-PA as a thrombolytic agent for the treatment of acute myocardial infarction be delayed. Justification for the Advisory Panel's action appears to be based on a lack of adequate data supporting the clinical benefit and safety of a specific therapeutic regimen of rt-PA, i.e., its molecular form, dosage, and duration of therapy. Although not an issue in the Panel's decision, questions can be raised concerning claims that rt-PA, in comparison to streptokinase, is a safer agent as far as bleeding complications are concerned, and is twice as effective in dissolving coronary thrombi during a period of potential clinical benefit. Also to be considered is the association of its use with a higher incidence of rethrombosis and a much greater cost.
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Sol Sherry (1987) conducted an editorial in acute myocardial infarction. rt-PA vs. streptokinase was evaluated. rt-PA approval for acute myocardial infarction was recommended for delay by the FDA Advisory Panel due to inadequate data on clinical benefit, safety, and optimal therapeutic regimen.