Highlight
• Only about one-fifth of women diagnosed with menopause initiated systemic hormone therapy (HT) within one year.
• Younger age, prior hysterectomy, and local hormone use increase likelihood of HT initiation.
• Black racial and Hispanic ethnic identities predict lower initiation rates and faster HT discontinuation.
• Median duration of first HT episode is 6.6 months, with less than 40% continuation at 12 months, highlighting persistence challenges.
Study Background
Menopause affects nearly all women, often accompanied by symptomatic vasomotor, urogenital, and psychological disturbances that can significantly impair quality of life. Systemic hormone therapy (HT) remains the most effective treatment for alleviating menopausal symptoms, yet real-world patterns of its initiation and persistence remain incompletely understood. Prior clinical trials have established the efficacy of HT but have also raised concerns regarding potential risks, leading to cautious and variable treatment utilization. Moreover, sociodemographic factors such as race and comorbidities may influence access to and continuation of HT. Understanding real-world utilization patterns, including disparities and adherence, is essential to identifying gaps and informing equitable clinical care strategies for menopausal women.
Study Design
This observational cohort study utilized the Merative™ MarketScan® Research Databases covering 2009-2022. Women aged 45 to 60 years with claims indicative of menopause were included, requiring at least 12 months of continuous enrollment to ensure adequate data capture. Exclusion criteria encompassed bilateral oophorectomy, breast or gynecologic malignancies, and contraindications to hormone therapy to focus on typical menopausal management. Multivariable regression models were employed to assess factors associated with the initiation of systemic HT, the choice of formulation (estrogen alone, progestogen alone, or combined), and the duration and discontinuation risk of the therapy. Demographic, clinical, and treatment variables were adjusted for confounding.
Key Findings
HT Initiation Rate and Predictors: Among 318,621 eligible women, 21.7% initiated systemic HT within one year following menopause diagnosis. Initiation was notably higher in younger women (aOR 2.17, 95% CI 2.12–2.23 for younger vs older age), those with a prior hysterectomy (aOR 1.98, 95% CI 1.77–2.21), and women using local hormone therapies (aOR 3.25, 95% CI 3.05–3.47), suggesting that clinicians may tailor systemic HT based on individual patient history and symptomatology.
Conversely, initiation was significantly lower among women with obesity (aOR 0.78, 95% CI 0.75–0.81) and diabetes (aOR 0.69, 95% CI 0.66–0.72), likely reflecting caution owing to potentially increased cardiovascular and metabolic risks. Importantly, Black women had a decreased likelihood of initiating systemic HT (aOR 0.78, 95% CI 0.68–0.89), highlighting important ethnic disparities in treatment access or acceptance.
Formulation Patterns: Initial systemic HT formulations were predominantly estrogen plus progestogen (52.5%), followed by estrogen alone (32.4%) and progestogen alone (15.1%). The use of estrogen alone is typically reserved for women without a uterus to mitigate endometrial hyperplasia risk. The significant proportion of combined therapy suggests many recipients retain their uterus or require progestogen for other clinical considerations.
Duration and Persistence: Median duration of the first HT episode was 6.6 months, with only 38.8% of women remaining on therapy at one year. Discontinuation occurred more rapidly among Black (aHR 1.52; 95% CI 1.34–1.73) and Hispanic women (aHR 1.43; 95% CI 1.14–1.80), indicating again racial and ethnic disparities not only in initiation but also in treatment persistence. Prior hysterectomy (aHR 0.75, 95% CI 0.68–0.83) and concurrent local hormone use (aHR 0.84, 95% CI 0.80–0.89) were protective against early discontinuation, suggesting a possible relationship between symptom overlap or combined treatment reinforcing adherence.
These findings emphasize the substantial drop-off in systemic HT use shortly after initiation despite its established symptomatic benefits, raising concerns about suboptimal management of menopausal symptoms in routine care settings.
Expert Commentary
The study sheds crucial light on the real-world application of systemic hormone therapy in menopausal women, confirming prior clinical observations that treatment adherence and persistence are generally low, even among those who start HT. The marked racial and ethnic disparities underscore systemic barriers, including possible mistrust, differential counseling, socioeconomic challenges, and variations in clinician prescribing patterns. Previous literature and guidelines, such as those from the North American Menopause Society, emphasize individualized patient counseling and risk-benefit discussions; however, this study suggests that implementation remains uneven across populations.
Additionally, comorbid conditions like obesity and diabetes may lead to more conservative prescribing, but these groups may also suffer disproportionately from untreated menopausal symptoms, necessitating careful risk stratification and possibly alternative therapeutic approaches. The shorter median duration of use and rapid discontinuation commonly observed could reflect adverse effects, insufficient symptom relief, or patient concerns about HT safety raised by historical debates following the Women’s Health Initiative findings.
Future research should focus on qualitative studies to explore patient and provider perspectives driving these patterns, and intervention studies aimed at reducing disparities and improving medication adherence are warranted. Moreover, the recognition that real-world HT use is likely undercoded suggests even greater gaps in care than observed.
Conclusion
This expansive population-based analysis demonstrates that while approximately one in five menopausal women initiate systemic hormone therapy, persistence remains a significant challenge, with less than 40% maintaining therapy at one year. Compounding this are evident racial and ethnic disparities that disadvantage Black and Hispanic women regarding HT initiation and continuation. Given the burden of menopausal symptoms and HT’s efficacy, these findings highlight critical unmet needs for equitable, patient-centered strategies to optimize menopausal care. Clinicians should be aware of these disparities and barriers and strive for tailored, culturally competent counseling and support to enhance treatment adherence and symptom management. Policies and clinical programs must address underlying social determinants and systemic biases to improve health outcomes in this large and diverse patient population.
Funding and ClinicalTrials.gov
The study used de-identified claims data from the Merative™ MarketScan® Research Databases and did not report specific funding sources or clinical trial registry entries.
References
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