Utilisation pattern of hormonal replacement therapy in UK general practice between 2000 and 2016

Study type
Protocol
Date of Approval
Study reference ID
18_034
Lay Summary

The decrease in production of female hormones after menopause (1 year after the last menstrual bleeding) results in more menopausal symptoms such as night sweats, hot flashes, and vaginal dryness in many women. Hormone replacement therapy (HRT) can be prescribed to alleviate these symptoms.
In 2002, the results of the Women's Health Initiative Study (WHI) were published, indicating that users of HRT are at higher risk of developing breast cancer and cardiovascular events such as heart attack and stroke compared to non users. As a consequence, many women stopped their hormone replacement therapy. Meanwhile, the association between use of HRT and cardiovascular events has been questioned.
The most recent information on HRT utilisation in the United Kingdom dates from 2005. We plan to describe the utilisation pattern of HRT in the United Kingdom between 2000 and 2016. We expect that the number of women using HRT has again increased since 2006, as more recent studies have revised the risk for adverse cardiovascular events associated with the therapy.

Technical Summary

We plan to first perform a descriptive study in which we describe utilisation patterns of estrogen replacement therapy with or without progesterone (henceforth to be referred to as HRT) in postmenopausal women between 2000 and 2016. We will estimate the prevalence of HRT use by calendar year in women aged 40-79 years overall and by therapy type, estrogen application route, and estrogen dosage. We will further calculate incidence rates (IR) of new HRT use each calendar year in women aged 40 79 years overall, as well as categorized by age groups and geographical region.
We will then describe prevalence of characteristics in prevalent HRT users and non users in each year by performing a cross-sectional study in each calendar year. We will further describe mean age, ethnicity, lifestyle (smoking, alcohol consumption), body mass index (BMI), socioeconomic status (SES), certain comorbidities, and co-medications of prevalent HRT users and non users in each year.
This study will be the first to describe HRT utilisation patterns in the United Kingdom (UK) after 2005.

Health Outcomes to be Measured

Hormonal replacement therapy use
- Hysterectomy
- Venous thromboembolic events
- Migraine
- Breast cancer
- Myocardial infarction
- Bilateral oophorectomy
- Statin use
- Ischaemic stroke
- Menopausal symptoms
- Psychiatric problems
- Asthma

Collaborators

Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Marlene Rauch - Corresponding Applicant - University of Basel
Christoph Meier - Collaborator - University of Basel
Manon Moser - Collaborator - University of Basel
Theresa Burkard - Collaborator - University of Basel

Former Collaborators

Christoph Meier - Collaborator - University of Basel

Linkages

HES Admitted Patient Care;Patient Level Index of Multiple Deprivation