Evaluation of efficacy and safety of conjugated estrogens/bazedoxifene in a Latin American population

Abstract

Introduction Conjugated estrogens/bazedoxifene (CE/BZA) relieves menopausal symptoms and increases bone mineral density (BMD).

Objective To evaluate CE/BZA in a Latin American subpopulation from randomized, double-blind, phase-3, multinational trials.

Methods Safety data were pooled from three trials from non-hysterectomized postmenopausal Latin American women assigned to CE 0.45 mg/BZA 20 mg (n = 227), CE 0.625 mg/BZA 20 mg (n = 222), or placebo (n = 193). Efficacy outcomes from one study included changes in hot flush frequency at week 12 in women with at least seven moderate/severe hot flushes/day or 50/week at baseline (n = 39), and from baseline to month 12 for BMD (n = 381) and genitourinary syndrome of menopause (GSM) (women with baseline GSM; n = 189).

Results At week 12, women taking CE/BZA had four to five fewer moderate/severe hot flushes/day vs. placebo. At month 12, percentage changes in BMD with CE 0.45 mg/BZA 20 mg, CE 0.625 mg/BZA 20 mg, and placebo were 1.2%, 1.6%, and –1.1% for lumbar spine and 1.1%, 1.2%, and –0.3% for total hip. GSM improved with treatment (percentage superficial cells: 4.5, 7.4, vs. 2.0; percentage parabasal cells: –9.3, –27.8 vs. 2.8). There were no new/unexpected safety trends.

Conclusion CE/BZA improved vasomotor symptoms, GSM, and BMD in Latin American women, with efficacy/safety similar to the global population.

Keywords:

• Latin America
• conjugated estrogens/bazedoxifene
• menopause
• hot flushes
• hot flashes
• osteoporosis
• genitourinary syndrome of menopause
• vulvar vaginal atrophy
• TSEC

Acknowledgements

Medical writing support was provided by Lauren Cerruto and Diane Sloan, PharmD, of Peloton Advantage and was funded by Pfizer.

Conflict of interest

S. Palacios has been a symposium speaker or advisory board member for Servier, Pfizer, GSK, Abbott, Ferrer, Bioiberica, Shionogi and Amgen and has received research grants and/or consulting fees from Pfizer, Servier, Amgen, MSD, Preglem, Leon Farma, and Gynea. L. Arias was an employee of Pfizer at the time of this data analysis. J. Lavenberg, B. S. Komm and K. Pan are employees of Pfizer. S. Mirkin was an employee of Pfizer at the time of this data analysis.

Source of funding

This study was sponsored by Pfizer.