Effects of aromatase inhibitor therapy on adiposity and cardiometabolic health in postmenopausal women: a controlled cohort extension study.

Abstract

We previously demonstrated that 12-months of aromatase inhibitor (AI) treatment was not associated with a difference in body composition or other markers of cardiometabolic health when compared to controls. Here we report on the pre-planned extension of the study. The pre-specified primary hypothesis was that AI therapy for 24-months would lead to increased visceral adipose tissue (VAT) area when compared to controls. We completed a 12-month extension to our prospective 12-month cohort study of 52 women commencing AI treatment (median age 64.5 years) and 52 women with breast pathology not requiring endocrine therapy (63.5 years). Our primary outcome of interest was VAT area. Secondary and exploratory outcomes included other measures of body composition, hepatic steatosis, measures of atherosclerosis and vascular reactivity. Using mixed models and the addition of a fourth-timepoint, we increased the number of study observations by 79, and were able to rigorously determine the treatment-effect. Among study completers (AI=39, controls=40), VAT area was comparable between groups over 24-months, mean-adjusted difference (-1.54cm2 [95% CI: -14.9; 11.9], p=0.79). Both groups demonstrated parallel and continuous increases in VAT area over the observation period, that did not diverge or change between groups. No statistically significant difference in our secondary and exploratory outcomes were observed between groups. While these findings provide reassurance that short-to-medium-term exposure to AI therapy is not associated with metabolically adverse changes when compared to controls, risk evolution should be less focused on the AI-associated-effect, and more on the general development of cardiovascular risk over time.