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MOSES: superiority or noninferiority?

To the Editor:

The MOSES Investigators conclude that for a similar level of blood pressure control eposartan demonstrates a protective effect relative to nitrendipine in hypertensive patients with a history of stroke.1 What is the basis of this claim? No difference in mortality or disability (either cognitive or physical) was demonstrated. The claim appears to be based on a significant difference in the composite end point using the incidence density rather than a traditional survival analysis (Table 3). A Cox proportional hazards analysis is given in Table 4 but only for the components of the primary end point and not the primary end point itself. There is no evidence from this analysis that cerebrovascular events are different between the groups. Yet, the incidence density approach (Table 3), preferred by the authors, suggests that there is. Which are we to believe? We must surely be cautious in accepting a result if it depends on the type of analysis used to obtain it. It would be interesting to see the result of a traditional survival analysis (excluding recurrent events) on the primary end point.

A further point …