The impact of risk status, preexisting morbidity, and polypharmacy on treatment decisions concerning menopausal symptoms

Abstract

Because each menopausal treatment has a unique benefit–risk profile, deciding whether menopausal hormone therapy (HT) or another menopausal treatment is appropriate for an individual requires assessing the risks and benefits of each treatment as well as determining the patient's risk factors, comorbidities, and current medications. Simple summary metrics for assessing net treatment effects on multiple outcomes, such as the Women's Health Initiative's (WHI) global index, are not necessarily generalizable beyond the study population in which they were derived. However, trial evidence can be translated to individual decisions by transforming relative risks into absolute risks. The validity of generalizing relative risks found in clinical trials to groups with differing baseline risks depends on the homogeneity of relative risks across various risk strata. Subgroup analyses from the major clinical studies of HT found its relative risks on cardiovascular disease, hip fracture, breast cancer, colorectal cancer, and ovarian cancer to be relatively uniform across strata defined by age, race/ethnicity, antecedent risk status, or prior disease. The number of significant subgroup findings in these studies tended to match the number expected by chance alone. However, data are limited for many subgroups, especially those with comorbidities. Strata defined by the concurrent use of drugs that could interact with HT would not be expected to be homogeneous, yet data on drug interactions are limited. More data are needed about the effects of menopausal treatments in diverse populations, and more attention is needed to translate this evidence into clinical practice and to develop tools to support informed decision making.