Natural menopause is the process by which women stop having periods due to aging and is the result of a decline in specific hormones within the body. As women remain very active after menopause, it is crucial that they can maintain ability to do regular activities. However, menopausal women can experience a variety of symptoms that impact on their daily routine, the most bothersome reported to be hot flashes (often termed vasomotor symptoms [VMS]) and sleep disturbances. Treatment options for these symptoms include hormone therapy (HT), the most effective treatment currently approved for hot flashes. However, many women cannot use hormone therapy due to them having certain other conditions, such as breast cancer or history of heart attack. Additionally, some women choose not to take HT because of concerns around the safety of the treatment. It is important to quantify the number of patients with menopausal symptoms who might benefit from treatments that don’t contain hormones in order to manage their symptoms and maintain regular activities.
This study will assess the number of natural menopausal woman who experienced VMS or sleep disturbances between 2010 and 2019 in healthcare databases across 5 different countries including the UK, and describe these patients in terms of their age, use of medications and other diseases they may experience before and after the menopause. The number of women experiencing VMS or sleep disturbances will also be assessed in those patients not able to use HT and their characteristics also described.
This study aims to assess the epidemiology of vasomotor symptoms (VMS) and sleep disturbances in menopausal women and menopausal women ineligible for hormone therapy (HT) due to contraindications.
The primary objective is to assess the incidence and prevalence of VMS and sleep disturbances in natural menopausal women. The secondary objectives are to assess the incidence and prevalence of VMS and sleep disturbances in natural menopausal women ineligible for HT and those treated with endocrine-adjuvant therapy. The study will also characterize demographic and clinical characteristics of these patient groups.
This is a multi-national retrospective cohort study. Seven target cohort definitions have been designed to address the study objectives. Prevalence and incidence rates of VMS and sleep disturbances between 2010-2019 in each cohort will be calculated: persons within the cohort who had VMS/sleep disturbances divided by cumulative total person time in years that patients were at risk of the outcome. Baseline characteristics (age, BMI) will be assessed along with comorbidities and medication use characterized within multiple time periods relative to cohort entry. Kaplan-Meier analyses will assess time from cohort entry to time to VMS and sleep disturbances.
Women can experience a variety of physical and psychological menopausal symptoms that impact quality of life, work productivity and daily routine. VMS, along with sleep disturbances and mood changes, are the most frequent and bothersome symptoms reported. Prevalence rates vary widely in the literature, partly because of methodological and demographic differences. It is important to understand the epidemiology to understand the patients unmet medical need for effective treatments. This study will be executed on several observational healthcare databases including CPRD, mapped to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) standardizing the representation of healthcare data enabling systematic analysis on disparate observational databases across five countries (UK, US, Japan, France, Germany).
Prevalence of vasomotor symptoms; Prevalence of sleep disturbances; Incidence of vasomotor symptoms; Incidence of sleep disturbances; Patient characteristics: age; body mass index; comorbidities; medication use
Victoria Banks - Chief Investigator - Bayer AG
Victoria Banks - Corresponding Applicant - Bayer AG
Cecile Janssenswillen - Collaborator - Bayer AG
Renate Schulze-Rath - Collaborator - Bayer AG
Ronald Herrera - Collaborator - Bayer AG
Siir Su Saydam - Collaborator - Bayer AG