Abstract | OBJECTIVE: METHODS: Data were pooled from five randomized, double-blind, placebo- and active-controlled studies in postmenopausal women aged 40 to 75 years with a uterus given CE 0.45 mg/BZA 20 mg (n = 1,607), CE 0.625 mg/BZA 20 mg (n = 1,598), or placebo (n = 1,256) for at least 12 weeks and up to 2 years. Changes from baseline in body weight, BMI (kg/m(2)), and World Health Organization BMI category (underweight <18.5; normal 18.5 to <25; overweight 25 to <30; obese ≥30) during treatment were evaluated. RESULTS: Mean body weight increased less than 0.9 kg and mean BMI increased less than 0.4 kg/m(2) in all treatment groups at all time points. There were no statistically significant between-group differences, except for significantly greater increases in weight (P = 0.015) and BMI (P = 0.014) with placebo versus CE 0.625 mg/BZA 20 mg at month 12. Approximately, 10% of women in the CE/BZA groups and 11% in the placebo group had increases in body weight greater than 7% of baseline. The majority of BMI changes were within ±7%, and there were no statistically significant between-group differences in BMI category distributions during treatment. CONCLUSIONS: Significant increases in body weight or BMI were not observed in postmenopausal women receiving CE 0.45 mg/BZA 20 mg or CE 0.625 mg/BZA 20 mg for up to 2 years in the Selective Estrogens, Menopause, and Response to Therapy trials.
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Authors | Denise Black, Michael Messig, Ching-Ray Yu, Annlouise R Assaf, Barry S Komm, Sebastian Mirkin, Matthieu Boucher |
Journal | Menopause (New York, N.Y.)
(Menopause)
Vol. 23
Issue 4
Pg. 376-82
(Apr 2016)
ISSN: 1530-0374 [Electronic] United States |
PMID | 26694733
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Estrogens, Conjugated (USP)
- Indoles
- Placebos
- Selective Estrogen Receptor Modulators
- bazedoxifene
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Topics |
- Adult
- Aged
- Body Mass Index
- Body Weight
(drug effects)
- Double-Blind Method
- Estrogens, Conjugated (USP)
(adverse effects, therapeutic use)
- Female
- Hot Flashes
(drug therapy)
- Humans
- Indoles
(adverse effects, therapeutic use)
- Middle Aged
- Placebos
- Postmenopause
- Selective Estrogen Receptor Modulators
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