title: Lipid profiles within the SABRE trial of anastrozole with and without risedronate.
abstract: 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. 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 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). 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 months assessments to suggest that any of these therapies have a negative impact on the lipid profile. 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 months monitoring period.
authors: Department of Internal Medicine, University of Michigan Comprehensive Cancer Center, 1500 East Medical Center Drive, C346 Med Inn Building, Ann Arbor, MI 48109-5848, USA. cvanpoz@umich.edu
authors: Catherine
authors: C
authors: Van Poznak
authors: Andreas
authors: A
authors: Makris
authors: Glen
authors: G
authors: Clack
authors: David H
authors: DH
authors: Barlow
authors: Richard
authors: R
authors: Eastell
mesh_terms: D000328:Adult; D000368:Aged; D000077384:Anastrozole; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism*; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D012968:Etidronic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008055:Lipids / Q000097:blood*; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage; D000068296:Risedronic Acid; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage; D014280:Triglycerides / Q000097:blood
chemical_list: D018931:Antineoplastic Agents, Hormonal; D050071:Bone Density Conservation Agents; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D008055:Lipids; D009570:Nitriles; D014230:Triazoles; D014280:Triglycerides; D000077384:Anastrozole; D000068296:Risedronic Acid; D012968:Etidronic Acid