A Pooled Analysis of the Effects of Conjugated Estrogens/Bazedoxifene on Lipid Parameters in Postmenopausal Women From the Selective Estrogens, Menopause, and Response to Therapy (SMART) Trials.

Abstract

CONTEXT Menopausal lipid profile changes may increase cardiovascular risk. The effects of conjugated estrogens (CE)/bazedoxifene (BZA), an approved menopausal therapy, on lipids have not been fully characterized. OBJECTIVE The purpose of this study was to determine the effects of CE/BZA on lipids in the Selective estrogens, Menopause, And Response to Therapy (SMART) trials for ≥ 1 year. DESIGN This was a pooled analysis of 3 randomized, double-blind, placebo (PBO)-controlled phase 3 trials (SMART-1, -4, and -5). SETTING The study was conducted in North America, Europe, Asia-Pacific Region, and Latin America. PARTICIPANTS Participants were nonhysterectomized postmenopausal women aged 40 to 75 years, not taking lipid-lowering medications (N = 2796). INTERVENTIONS Treatments were CE 0.45 mg/BZA 20 mg, CE 0.625 mg/BZA 20 mg, and PBO. MAIN OUTCOME MEASURES The adjusted mean percentage changes from baseline in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides, and the LDL-C/HDL-C ratio at 12 and 24 months were measured. RESULTS At 12 months, CE 0.45 mg/BZA 20 mg and CE 0.625 mg/BZA 20 mg produced significant (P < .001) improvements vs PBO in TC (-4.20% and -4.37% vs -0.88%), LDL-C (-9.33% and -10.78% vs -1.08%), HDL-C (4.59% and 6.21% vs 1.30%), and the LDL-C/HDL-C ratio (-11.59% and -14.00% vs -0.84%). Triglycerides were significantly (P < .001) increased from baseline with both doses vs PBO (15.13% and 15.74% vs 4.43%). Similar trends (all P < .001) were seen at 24 months when SMART-1 and SMART-4 were pooled (TC: -3.25% and -3.13% vs 0.95%; LDL-C: -7.47% and -8.08% vs 2.95%; HDL-C: 5.91% and 7.19% vs 1.72%; triglycerides: 18.87% and 18.82% vs 6.49%; and the LDL-C/HDL-C ratio: -10.05% and -12.82% vs 2.56%). CONCLUSIONS CE/BZA was associated with mostly favorable changes in lipid parameters for up to 2 years in nonhysterectomized postmenopausal women.

DOI: 10.1210/jc.2014-2649

Cite this paper

@article{Stevenson2015APA, title={A Pooled Analysis of the Effects of Conjugated Estrogens/Bazedoxifene on Lipid Parameters in Postmenopausal Women From the Selective Estrogens, Menopause, and Response to Therapy (SMART) Trials.}, author={John C. Stevenson and Arkadi A. Chines and Kaijie Pan and Kelly A Ryan and Sebasti{\'a}n Mirkin}, journal={The Journal of clinical endocrinology and metabolism}, year={2015}, volume={100 6}, pages={2329-38} }