Dataset Information

Effects of combined 17?-estradiol and progesterone on weight and blood pressure in postmenopausal women of the REPLENISH trial.

ABSTRACT:

Objective

To examine the impact of a single-capsule 17?-estradiol (E2)/progesterone (P4) on weight and blood pressure (BP) when treating moderate to severe vasomotor symptoms in postmenopausal women with a uterus.

Methods

Healthy postmenopausal women with a uterus (aged 40-65, body mass index ?34?kg/m2, BP ?140/90 mm Hg) were randomized to daily E2/P4?(mg/mg; 1/100, 0.5/100, 0.5/50, 0.25/50) or placebo in the phase 3 REPLENISH trial (NCT01942668). Changes in weight and BP from baseline to month 12 were evaluated. Potentially clinically important changes were defined as increases or decreases from baseline in weight by ?15% and ?11.3?kg, systolic BP by ?20 mm Hg (absolute value ?160 or ?90 mm Hg), and diastolic BP by ?15 mm Hg (absolute value ?90 or ?60 mm Hg).

Results

Overall mean changes in weight and BP from baseline to month 12 with E2/P4 were modest and generally not statistically or clinically significant versus placebo. Incidence of potentially clinically important changes was low for weight (E2/P4 vs placebo: 1.1-2.6% vs 2.2%), systolic BP (0.3-1.1% vs 1.1%), and diastolic BP (1.4-4.2% vs 3.2%). A small number of women had treatment-related, treatment-emergent adverse events of weight gain (1.4-2.6% vs 1.3%) or hypertension (0.2-1.2% vs 0%). Few women who discontinued E2/P4 had weight gain (1.6%) or hypertension (0.6%) as a primary reason. Efficacy profile on VMS was consistent with previous findings and not modified by body mass index.

Conclusions

Twelve-month use of E2/P4 had no clinically meaningful impact on weight or BP in postmenopausal women of the REPLENISH study.

SUBMITTER: Black DR

PROVIDER: S-EPMC7769186 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Effects of combined 17β-estradiol and progesterone on weight and blood pressure in postmenopausal women of the REPLENISH trial.

Black Denise R DR Minkin Mary Jane MJ Graham Shelli S Bernick Brian B Mirkin Sebastian S

Menopause (New York, N.Y.) 20200914 1

<h4>Objective</h4>To examine the impact of a single-capsule 17β-estradiol (E2)/progesterone (P4) on weight and blood pressure (BP) when treating moderate to severe vasomotor symptoms in postmenopausal women with a uterus.<h4>Methods</h4>Healthy postmenopausal women with a uterus (aged 40-65, body mass index ≤34 kg/m2, BP ≤140/90 mm Hg) were randomized to daily E2/P4 (mg/mg; 1/100, 0.5/100, 0.5/50, 0.25/50) or placebo in the phase 3 REPLENISH trial (NCT01942668). Changes in weight and BP from bas ...[more]

PMID: 32932401

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