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February 3, 1999

Coronary Events With Lipid-Lowering Therapy: The AFCAPS/TexCAPS Trial—Reply

Author Affiliations

Margaret A.WinkerMD, Deputy EditorIndividualAuthorPhil B.FontanarosaMD, Interim Co-EditorIndividualAuthor

JAMA. 1999;281(5):414-419. doi:10-1001/pubs.JAMA-ISSN-0098-7484-281-5-jbk0203

In Reply: The preceding letters raise 4 issues regarding the interpretation of AFCAPS/TexCAPS: subgroups, the absence of conclusive mortality data, cost-effectiveness, and noncardiovascular events.

Prespecified treatment by subgroup interactions were performed to show consistency between the subgroups and the overall results, not to establish efficacy within the subgroups. It is not statistically appropriate to perform between-treatment comparisons within subgroups (eg, women) when there is no interaction between the subgroup factor and treatment, as was the case for sex and treatment in AFCAPS/TexCAPS (ie, similar treatment effects for men and women). However, if this test is performed, there is also inadequate sample size to find a significant effect in women (n=997, RR=0.54, 95% confidence interval, 0.22-1.35). As AFCAPS/TexCAPS is the first primary prevention study with a statin to include women, we considered it important to report that treatment did not appear to work differently or less effectively in women.

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