Lipid profiles within the SABRE trial of anastrozole with and without risedronate

Abstract

Introduction Lipid profiles in women with early breast cancer receiving anastrozole with or without risedronate were examined within an international Phase III/IV study to assess for possible treatment related changes. Methods Postmenopausal women with hormone receptor-positive breast cancer were assigned to 1 of 3 strata by risk of fragility fracture. Patients with the highest risk for fracture received anastrozole plus risedronate (A+R). Moderate-risk patients were randomized in a double-blind manner to anastrozole and risedronate (A+R) or anastrozole and placebo (A+P). Lower-risk patients received anastrozole (A) alone. Serial fasting blood samples were assessed for changes in lipid parameters relative to baseline after 12 months of treatment with anastrozole with or without risedronate. Samples were centrally analyzed for low density lipoprotein cholesterol (LDL-cholesterol), high density lipoprotein (HDL) cholesterol, total cholesterol (TC) and triglycerides (TG). Analysis was performed as primary analysis population for lipids (A plus A+P), lipid intention to treat population and secondary population (A+R). Results Of the 119 patients treated with A plus A+P, there were 66 patients eligible for inclusion in the primary analysis population. Of the 115 patients treated with secondary population (A+R) there were 65 patients eligible for lipid profiling. For LDL cholesterol, HDL cholesterol, TC and TG there were no significant changes between the baseline and 12 month assessments to suggest that any of these therapies have a negative impact on the lipid profile. Conclusions In this study of postmenopausal women with early breast cancer receiving adjuvant anastrozole with or without risedronate, there was no adverse effect on LDL cholesterol, HDL cholesterol, TC or TG values over the 12 month monitoring period.

Prevention of aromatase inhibitor-induced bone loss with alendronate in postmenopausal women: The BATMAN Trial

“…Our analysis also showed that there were no meaningful lipid changes with anastrozle, as a surrogate for cardiovascular health. This is in keeping with the TEAM Japan [17] , TEAM Greek [18] sub-studies and the SABRE trial [19] , which showed that AIs have no detrimental effects on lipid parameters. This is reassuring when using AIs in women with favourable prognosis breast cancer.…”

Cardiovascular Disease After Aromatase Inhibitor Use

“…Although early reports suggested adverse influence of AIs on lipoproteins, more recent studies question that paradigm. No adverse lipid effects for anastrozole were observed in the Study of Anastrozole With the Bisphosphonate Risedronate trial or for extended adjuvant exemestane therapy after tamoxifen. Two studies found adverse AI effects after tamoxifen use, but such results are consistent with either an AI effect and/or an effect of tamoxifen washout.…”

Higher Insulin Resistance and Adiposity in Postmenopausal Women With Breast Cancer Treated With Aromatase Inhibitors

“…The lack of difference in fasting lipid profile with aromatase inhibition is broadly in accord with existing evidence. Prospective evaluation of cholesterol after anastrozole therapy did not detect any significant difference in fasting lipid profile (36).…”