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To the Editor: In their meta-analyses^1-2 Dr Eikelboom and colleagues compare thrombolytic therapies for acute myocardial infarction (MI). Since meta-analyses of bolus-vs-infusion trials reveal no differences in efficacy, the choice of agent should be based on safety and cost. With regard to safety, the only statistically significant difference in the meta-analyses was a reduction in intracranial hemorrhages with infusion agents.^1-2

Does this statistically significant difference translate into a clinically relevant difference? Our formulary committee calculated the number needed to treat (NNT) from data for intracranial hemorrhage outcomes in all trials in Figure 3.¹ The NNT with infusion thrombolytic agents is 629 (95% confidence interval [CI], 328-7609) to avoid 1 intracranial hemorrhage that would have occurred with bolus administration. It is unclear whether 629 is a clinically relevant NNT. I would like to see pharmacoeconomic analyses to guide the interpretation of the NNT.

From a societal perspective, a large NNT may . . . [Full Text of this Article]

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RELATED ARTICLE

Safety Outcomes in Meta-analyses of Phase 2 vs Phase 3 Randomized Trials: Intracranial Hemorrhage in Trials of Bolus Thrombolytic Therapy
John W. Eikelboom, Shamir R. Mehta, Janice Pogue, and Salim Yusuf
JAMA. 2001;285(4):444-450.
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