How important clinically is a statistically significant 24% reduction of nonfatal myocardial infarction associated with therapy?
Dr. Gotto: One has to take this secondary end point in the context of the overall trial results. A subgroup analysis showed that the patients who had not had a previous cardiovascular event had a greater reduction in total cardiovascular disease events than those who had. Then this may be a matter of primary versus secondary prevention? Dr. Gotto: Yes—the results, at least in the subgroup analysis, showed benefit in what we would call primary prevention but not in secondary prevention. However, the 11% reduction in the primary end point failed to reach statistical significance. What do you make of that? Dr. Gotto: A major reason why the reduction did not reach statistical significance may have been that there was considerable “drop-in” use of statins during the trial, because of the positive statin trial results that were presented and published during the course of the FIELD trial, and because patients participating in the trial were not prohibited from starting statin therapy if thei
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