Menopause is typically experienced by women between the ages of 40 and 65 years. Many women experience hot flushes, night sweats and related symptoms, collectively known as vasomotor symptoms (VMS), which have been reported to persist for a number of years after a womans final menstrual period.
Symptom relief is at the centre of menopause management with the most common VMS treatment in the United Kingdom considered to be hormone replacement therapy (HRT).
Whilst HRT is effective in managing symptoms for many women, for some it has been reported to increase the chances of stroke, breast cancer and coronary heart disease (nonfatal myocardial infarction). Therefore, HRT may not always be the appropriate choice for managing VMS.
Where HRT is not an option for women with VMS, for example if they are already at high risk of cardiovascular disease, or if they are taking other medication that may prohibit HRT use, alternative options may be presented, such as anti-depressive medication, over the counter therapies, herbal remedies, diet and lifestyle changes. There has been little reported success in overall symptom alleviation with alternative therapies.
The aim of this study is to understand the real world treatment landscape of women with VMS. We will describe the proportion of women of menopausal age (40-65 years) who have been diagnosed with VMS in the last ten years, and report treatments prescribed for VMS patients (in their first year after being diagnosed, and also over their course of their patient history in the study). We will also look to understand how often women use resources in primary care and secondary care for VMS related events.
Women of menopausal age, typically 40-65 years, can experience hot flushes, night sweats and related symptoms, collectively known as vasomotor symptoms (VMS). These symptoms have been reported to persist for a median of 4.5years after a womans final menstrual period [Avis et al, 2015]. Whilst hormone replacement therapy (HRT) are commonly prescribed for symptomatic relief, HRT may not always be the appropriate choice, due to contraindications or high-risk of treatment related adverse events such as stroke, breast cancer and coronary heart disease (nonfatal myocardial infarction)].
There has been limited reporting of the real world treatment landscape for women with VMS, which is needed for foundational insight on the management of VMS.
This study aims to describe the incidence, prevalence, treatment patterns and health care resource use of women with VMS. This is a descriptive study using the most recent 10 years of linked electronic medical records from the UK (Gold).
VMS cases will be captured using Read code diagnosis, and will be described in terms of their patient characteristics and a-priori selected comorbidities. The annual incidence rate of VMS among the general population of woman of menopausal age will be estimated, along with annual point prevalence of VMS. For incident cases, the first line treatment received (hormonal, non-hormonal, no treatment) post VMS diagnosis will be reported, as well as subsequent treatment pattern in their patient history. The duration of first line treatment (persistence) will be described, along with a proxy measure for treatment adherence (medication possession ratio).
In addition, in a subset of English patients eligible for linkage with HES data, the health care resource use of VMS cases will be described and will include the number of hospital outpatient visits, number of inpatient admissions, total length of stay in hospital for the inpatient admissions for menopause related symptoms.
VMS cases (for incidence and prevalence calculations); Treatment patterns (hormonal, non-hormonal, or no treatment) for calculating the proportion of patients first line treatment (within12months post VMS diagnosis); Treatment patterns (eight treatment groups) for reporting sequential lines of treatment post VMS diagnosis (over the follow-up period); Medication Possession Ratio as a proxy measure for adherence; Duration of treatment (persistence) for first line of treatment post VMS diagnosis over follow-up period; Healthcare resource utilisation including number of GP visits, hospital outpatient visits, inpatient admissions, diagnostic tests, procedures, and length of stay in hospital.
Please also see Section N for more details.
Matthias Stoelzel - Chief Investigator - Astellas Pharma Europe Ltd. - UK
Matthias Stoelzel - Corresponding Applicant - Astellas Pharma Europe Ltd. - UK
Bas van der Poel - Collaborator - Astellas Pharma Europe Ltd. - UK
Matthias Stoelzel - Collaborator - Astellas Pharma Europe Ltd. - UK
HES Admitted Patient Care;HES Outpatient