Marlow, 28 November 2024 – The British Menopause Society has published the following response to a new study published in The BMJ: Contemporary menopausal hormone therapy and risk of cardiovascular disease: Swedish nationwide register based emulated target trial

Randomised controlled trials are the gold standard – they match participant demographics to ensure that outcomes are genuinely related to the intervention studied, irrespective of confounders, which for menopausal women include age, time since last menstrual period, body mass index, blood pressure, fasting lipid profile, family history and a personal history of diabetes.

Observational studies are inherently flawed, due to an inability to confirm patient compliance with medication and challenges relating to an accurate recording of patient outcomes. This also applies to studies using an emulated target trial design and this study does not build on the existing database associated with a more robust research methodology.

Registry database studies are inevitably influenced by confounders including the demographics of the population included and logistic regression analysis was not applied to this research to adjust for confounders.

The data provided in this study is not new information and should not influence clinical practice in the UK or elsewhere. It is important to acknowledge that the risk of a cardiovascular event increases with age in all women, irrespective of use of HRT. However transdermal estrogen minimises the risk of VTE by avoiding first pass activation of D-dimers in the liver.

This publication refers to a variety of different menopausal hormone therapies, including oral menopausal hormone therapy containing both estrogen with and without a progestogen, oral estrogen with local progestogen, tibolone, a unique oral formulation, which stimulates hormone receptors (gonadomimetic), transdermal therapy containing estrogen, with and without a progestogen, and no HRT.

It is also important to consider biological plausibility. With the wealth of research data that is available for the arterial and metabolic action of HRT, particularly estrogen, any claims that HRT is causing cardiovascular harm would need to demonstrate the biological basis for this.

ENDS

Sally Goodall
Transform Communications
01225 863846
sally@transformcomms.co.uk