Natural menopause is the process by which women stop having periods due to aging and is the result of decline in specific hormones within the body. Menopausal women can experience a variety of symptoms for a number of years that severely impact their daily routine, the most bothersome reported to be hot flashes (termed vasomotor symptoms [VMS]) and sleep disturbances. Effective treatment options include hormone therapy (HT) however, many women cannot use HT due to certain other conditions, such as breast cancer or history of heart attack. Some choose not to take HT because of concerns around the safety of the treatment. Antidepressants and other non-hormonal treatments are often prescribed to menopausal women despite them not being approved for VMS. It is important to understand the use of treatments for symptoms throughout the menopause, including in those unable to use HT, to understand the need for new non-hormonal treatment alternatives to relieve symptoms.
This study will describe the number of women receiving medications and the ordered sequence of such medications prescribed throughout menopause for various groups of menopausal woman, including those unable to use HT, using healthcare databases in the United States and the United Kingdom. The length of time women utilise each medication will also be reported. Additionally, women will be described in terms of age and other diseases they may experience before and after menopause. The number of women who experience different symptoms of menopause including VMS and sleep disturbances will also be reported.
This study aims to understand treatment pathways of prescription medications used to manage symptoms of menopause in a real-world setting.
Primary objectives – to describe treatment pathways and durations of treatments used to manage symptoms of menopausal women; describe demographics and clinical characteristics of menopausal women; to describe the frequency of drug utilization for treatments used to manage symptoms of menopause; to describe the incidence of symptoms of menopause.
‘Menopausal women' refers to the following cohorts: women with natural menopause; women with natural menopause contraindicated for hormonal therapy (HT); women with natural menopause and family history of breast cancer; women with/at high risk of breast cancer receiving endocrine therapy. Due to known limitations of the recording of menopause in healthcare databases, cohorts for exploratory objectives will focus on women of menopausal age with 1) a diagnosis of a menopausal symptom; 2) a prescription of HT.
This is a multi-national retrospective cohort study to be executed against 4 observational healthcare databases, including CPRD, mapped to the Observational Medical Outcomes Partnership Common Data Model in the US and UK.
Treatment utilisation and sequencing post cohort entry will be described and visualized using Sankey diagrams. Median time to treatment discontinuation will be calculated via Kaplan-Meier plots. Incidence rates of symptomatic events of menopause will be calculated. Patient characteristics prior to/post cohort entry will be summarized descriptively.
Women experience a variety of physical and psychological menopausal symptoms that impact quality of life. Treatments offered to manage symptoms include HT and non-hormonal treatments such as antidepressants often prescribed off-label. There is limited evidence on longitudinal treatment utilization patterns for symptoms of menopause across different demographics and geographies. This study will allow for better understanding of the treatments currently prescribed for menopausal symptoms, including in women contraindicated for HT, and the need for novel non-hormonal alternatives.
Treatment pathways/sequencing; frequency of drug utilisation; duration of treatment use; time to discontinuation of treatment; incidence of menopausal symptoms; demographics and clinical characteristics
Victoria Banks - Chief Investigator - Bayer AG
Victoria Banks - Corresponding Applicant - Bayer AG
Carina Dinkel-Keuthage - Collaborator - Bayer AG
Cecile Janssenswillen - Collaborator - Bayer AG
GEORGIOS ARGYRIOU - Collaborator - Bayer AG
Nils Schoof - Collaborator - Bayer AG
Siir Su Saydam - Collaborator - Bayer AG
GEORGIOS ARGYRIOU - Collaborator - Odysseus Data Services Inc
Martin Lavallee - Collaborator - Odysseus Data Services Inc