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• If the difference observed in BIG 1-98 is the consequence of a protective
effect of tamoxifen, the same should be seen in trials with other AIs.
1-4
• Within the limitations of trial methodology and across trial comparisons, an
increased rate of CV events seems to be seen in all three trials that
compared an AI with tamoxifen,
1-4
but not in the only trial, MA.17, to
compare an AI (letrozole) with placebo.
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• We must be cautious about intertrial comparisons:
• In IES, ischemic cardiovascular disease may include many cardiac
AEs of limited clinical importance.
4
• AE data were collected only during treatment + 30 days in certain
trials (eg, in ATAC).
3