During menopause woman’s ovaries stop working normally and the lower levels of the reproductive hormones, particularly oestrogen, stop her periods. This change also cause troublesome side-effects, such as hot flushes, mood changes, joint pains, sleep disturbance, and vaginal dryness. Some women are very badly affected and can find the problems life-changing.
Many women suffering from menopausal side-effects benefit from menopausal hormone therapy (MHT or known in the UK as ‘Hormone Replacement Therapy’ or HRT), which can eliminate or lessen these.
Changes in reproductive hormones can affect the heart and blood vessels, so low levels of these hormones after the menopause may affect the risk of heart attacks and strokes. Previous studies have suggested that the risks may be higher among some women who have used MHT/HRT. It is not yet clear, however, either whether this is true only for certain women, or whether or how risk levels may differ between specific treatments.
This study will reveal whether the risks are different for women currently on HRT/MHT or stopped in the past. This study will produce detailed information whether specific treatments change the risks. It will also investigate differences between different groups of women in relation to HRT/MHT treatments.
Our aim is that the information generated will improve understanding among patients and their doctors about the benefits and risks of using different MHT/HRT treatments, and lead to better prescribing choices.
Aim:
To estimate risks of acute cardiovascular disease (CVD) events (ischaemic stroke and myocardial infarction) associated with current and previous use of the range of menopausal hormone therapy (MHT) used in the UK National Health Service.
Methods:
• The proposed study will use CPRD (both GOLD and AURUM). Where practices contribute to both parts only data from GOLD will be used.
• This will be a nested case-control study. Every woman aged between 40 years and 100 years with a first record of CVD between 1998 and 2024 (case) will be matched by age and practice to up to 5 female controls with no records of CVD at the time of the case diagnosis (index date). Cases will be selected using general practice, ONS mortality and HES data.
• Associations between different uses of MHT (types, applications, different hormones, doses, durations of use, gap after the last use) will be assessed using conditional logistic regression.
• All available relevant potential factors (confounders) including demographics and CVD risk factors will be taken into account, and details of exposure to different types of MHT treatments will be assessed.
• Subgroup analyses for cases with myocardial infarction and ischaemic stroke will also be conducted.
• Risks related to patient characteristics (ethnicity, age and body mass index) will be investigated by subgroup analyses.
Impact:
The study will provide detailed and consistent information on the included CVD risks for different MHT hormonal preparations, describing those with higher or lower risks of developing CVD outcomes. The resulting detailed information on the risk estimates for included CVD events associated with different MHT treatments, taking into account both durations of treatment and intervals since the last use, will provide important additional data to inform decisions about menopause treatments and the need for wider access to such treatments.
First record of: cardiovascular disease event; acute myocardial infarction; ischaemic stroke; transient ischaemic attack.
Yana Vinogradova - Chief Investigator - University of Nottingham
Yana Vinogradova - Corresponding Applicant - University of Nottingham
Joe Kai - Collaborator - University of Nottingham
Ralph Kwame Akyea - Collaborator - University of Nottingham
HES Admitted Patient Care;ONS Death Registration Data;Patient Level Townsend Index;Practice Level Townsend Index