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Randomized Trial Evaluation of the Benefits and Risks of Menopausal Hormone Therapy Among Women 50-59 Years of Age.

ABSTRACT: The health benefits and risks of menopausal hormone therapy among women aged 50-59 years are examined in the Women's Health Initiative randomized, placebo-controlled trials using long-term follow-up data and a parsimonious statistical model that leverages data from older participants to increase precision. These trials enrolled 27,347 healthy postmenopausal women aged 50-79 years at 40 US clinical centers during 1993-1998, including 10,739 post-hysterectomy participants in a trial of conjugated equine estrogens and 16,608 participants with a uterus in the trial of these estrogens plus medroxyprogesterone acetate. Over a (median) 18-year follow-up period (1993-2016), risk for a global index (defined as the earliest of coronary heart disease, invasive breast cancer, stroke, pulmonary embolism, colorectal cancer, endometrial cancer, hip fracture, and all-cause mortality) was reduced with conjugated equine estrogens with a hazard ratio of 0.82 (95% confidence interval: 0.71, 0.95), and with nominally significant reductions for coronary heart disease, breast cancer, hip fracture, and all-cause mortality. Corresponding global index hazard ratio estimates of 1.06 (95% confidence interval: 0.95, 1.19) were nonsignificant for combined estrogens plus progestin, but increased breast cancer risk and reduced endometrial cancer risk were observed. These results, among women 50-59 years of age, substantially agree with the worldwide observational literature, with the exception of breast cancer for estrogens alone.

SUBMITTER: Prentice RL

PROVIDER: S-EPMC8086238 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Randomized Trial Evaluation of the Benefits and Risks of Menopausal Hormone Therapy Among Women 50-59 Years of Age.

Prentice Ross L RL Aragaki Aaron K AK Chlebowski Rowan T RT Rossouw Jacques E JE Anderson Garnet L GL Stefanick Marcia L ML Wactawski-Wende Jean J Kuller Lewis H LH Wallace Robert R Johnson Karen C KC Shadyab Aladdin H AH Gass Margery M Manson JoAnn E JE

American journal of epidemiology 20210201 3

The health benefits and risks of menopausal hormone therapy among women aged 50-59 years are examined in the Women's Health Initiative randomized, placebo-controlled trials using long-term follow-up data and a parsimonious statistical model that leverages data from older participants to increase precision. These trials enrolled 27,347 healthy postmenopausal women aged 50-79 years at 40 US clinical centers during 1993-1998, including 10,739 post-hysterectomy participants in a trial of conjugated ...[more]

PMID: 33025002

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Project description:Background and objectivesWomen who breastfeed may experience long-term benefits for their health in addition to the more widely appreciated effects on the breastfed child. Breastfeeding may induce long-term effects on biopsychosocial systems implicated in brain health. Also, due to diminished breastfeeding in the postindustrial era, it is important to understand the lifespan implications of breastfeeding for surmising maternal phenotypes in our species' collective past. Here, we assess how women's breastfeeding history relates to postmenopausal cognitive performance.MethodologyA convenience sample of Southern California women age 50+ was recruited via two clinical trials, completed a comprehensive neuropsychological test battery and answered a questionnaire about reproductive life history. General linear models examined whether cognitive domain scores were associated with breastfeeding in depressed and non-depressed women, controlling for age, education and ethnicity.ResultsWomen who breastfed exhibited superior performance in the domains of Learning, Delayed Recall, Executive Functioning and Processing Speed compared to women who did not breastfeed (P-values 0.0003-0.015). These four domains remained significant in analyses limited to non-depressed and parous subsets of the cohort. Among those depressed, only Executive Functioning and Processing Speed were positively associated with breastfeeding.Conclusions and implicationsWe add to the growing list of lifespan health correlates of breastfeeding for women's health, such as the lower risk of type-2 diabetes, cardiovascular disease and breast cancer. We surmise that women's postmenopausal cognitive competence may have been greater in past environments in which breastfeeding was more prevalent, bolstering the possibility that postmenopausal longevity may have been adaptive across human evolutionary history.Lay summaryBreastfeeding may affect women's cognitive performance. Breastfeeding's biological effects and psychosocial effects, such as improved stress regulation, could exert long-term benefits for the mother's brain. We found that women who breastfed performed better on a series of cognitive tests in later life compared to women who did not breastfeed.

Project description:BackgroundMenopausal hormone therapy (MHT) can elevate venous thromboembolism (VTE) risk, but less is known about formulations and routes of exposures.ObjectiveTo estimate hormone-associated VTE risk by route and formulation in exposed and unexposed women aged 50 to 64 years in the US.MethodsIn a nested case-control study of US commercially insured women aged 50 to 64 years (2007-2019), cases were defined as incident VTE diagnoses and matched to 10 controls by date of VTE and age, excluding prior VTE, inferior vena cava filter placement, or anticoagulants. Filled prescriptions in the prior year defined hormone exposures. International Classification of Diseases and Current Procedural Terminology codes identified risk factors and comorbidities.ResultsOdds ratios (ORs) were estimated with conditional logistic regression controlling for differences between cases (n = 20,359) and controls (n = 203,590) in comorbidities and VTE risk factors. For exposures within 60 days, oral MHT risk was almost twice as high as transdermal MHT (OR = 1.92; 95% CI, 1.43-2.60); transdermal MHT did not elevate risk compared with no exposure (unopposed OR = 0.70; 95% CI, 0.59-0.83; combined OR = 0.73; 95% CI, 0.56-0.96). Risk was highest for MHT combinations with ethinyl estradiol, followed by conjugated equine estrogen (CEE) (ethinyl estradiol-CEE: OR = 1.55; 95% CI, 1.07-2.25), and lowest for estradiol (CEE-estradiol: OR = 1.33; 95% CI, 1.02-1.72). Combined hormonal contraceptives elevated risk 5 times higher than no exposure (OR = 5.22; 95% CI, 4.67-5.84) and 3 times higher than oral MHT (OR = 3.65; 95% CI, 3.09-4.31).ConclusionThe risk of VTE is much lower with MHT than combined hormone contraceptives and varies by hormone formulation and route of exposure. Transdermal MHT did not elevate risk. Oral MHT combinations with estradiol were lower risk than other forms of estrogen. Oral combined hormone contraceptives had much higher risk than oral combined hormonal MHT.

Project description:ImportanceMenopausal hormone therapy (MHT) is the treatment of choice for symptoms of menopause. However, its adoption is hindered by the risk-benefit trade-off in relation to acute and chronic diseases.ObjectiveTo evaluate trends in and correlates of MHT use among postmenopausal women in the US from 1999 to March 2020.Design, setting, and participantsThis serial cross-sectional analysis of MHT use used data from the nationally representative National Health and Nutrition Examination Survey (NHANES). Participants included noninstitutionalized US postmenopausal women from 10 NHANES study cycles (1999-2000 to 2017-March 2020 [pre-COVID-19 pandemic]). Data were analyzed from December 2023 to April 2024.ExposuresNHANES study cycle.Main outcomes and measuresPrevalence of MHT use was extracted from the prescription medication data collected during NHANES household interviews. MHT formulations were determined by hormone type.ResultsData on 13 048 US postmenopausal women (47.1% ≥65 years old) were analyzed. From 1999 to 2020, the prevalence of MHT use decreased among women of all age groups, from 26.9% (95% CI, 22.6%-31.7%) in 1999 to 4.7% (95% CI, 3.4%-6.5%) in 2020. Until 2002, MHT use was highest among women aged 52 to 65 years, but since 2005, MHT use has been highest among women younger than 52 years. MHT use decreased by 23.5% (95% CI, 11.4%-35.6%), 31.4% (95% CI, 23.4%-39.5%), and 10.6% (95% CI, 6.3%-14.8%) for women younger than 52 years, 52 years to younger than 65 years, and 65 years and older, respectively. Prevalence of MHT use decreased from 13.8% (95% CI, 8.5%-21.7%) to 2.6% (95% CI, 1.5%-4.6%) for Hispanic women, 11.9% (95% CI, 8.5%-16.3%) to 0.5% (95% CI, 0.2%-1.1%) for non-Hispanic Black women, and 31.4% (95% CI, 27.1%-36.1%) to 5.8% (95% CI, 4.1%-8.2%) for non-Hispanic White women. Non-Hispanic White women consistently had the highest prevalence of MHT use. Estrogen-only formulation accounted for more than 50% of the MHT for most study periods. The prevalence of MHT use varied by family income-to-poverty ratio, health insurance coverage in all racial and ethnic groups, weight, and smoking status among non-Hispanic White women, as well as by education attainment among non-Hispanic Black and Hispanic women.Conclusions and relevanceResults of this cross-sectional study show that over the past 2 decades, MHT use declined among US postmenopausal women of all age and racial and ethnic groups. Women of racial and ethnic minority groups had lower prevalence of MHT use compared to non-Hispanic White women.

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Randomized Trial Evaluation of the Benefits and Risks of Menopausal Hormone Therapy Among Women 50-59 Years of Age.

Publications

Randomized Trial Evaluation of the Benefits and Risks of Menopausal Hormone Therapy Among Women 50-59 Years of Age.

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