Journal Club 12/02 Dr Stephen Newell. Current Problems in Pharmacovigilance October 2002 Safety update on long-term HRT. Coronary heart disease “The anticipated benefit of long-term use in preventing CHD, as suggested by observational studies, has not been supported by the RCT data.”.
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Dr Stephen Newell
Safety update on long-term HRT
“The anticipated benefit of long-term use in preventing CHD, as suggested by observational studies, has not been supported by the RCT data.”
a review of the evidence
Low AK, Russell LD, Holman HE, Shepherd JM, Hicks GS, Brown CA.
Am J Med Sci 2002 Oct;324(4):180-4
Major medical organizations particularly in the USA encouraged HRT for CHD risk reduction, along with using HRT for other potential benefits (such as osteoporosis prevention).
A study of HRT in postmenopausal women with ischaemic heart disease: the Papworth HRT atherosclerosis study
Clarke SC, Kelleher J, Lloyd-Jones H, Slack M, Schofield PM.
BJOG 2002 Sep;109(9):1056-62
MAIN OUTCOME MEASURES: Admission to hospital with unstable angina, proven myocardial infarction or cardiac death.
“Overall results from RCTs have shown an increase in the risk of stroke in HRT users.”
“The absolute risk associated with HRT is…higher.”
Harris PF. Curr Womens Health Rep 2002 Oct;2(5):373-81
RCTs reveal an association with cardiovascular events in women with known heart disease, a possibly diminished overall quality of life due to HRT, and worsening of urinary incontinence.
“The known increased risk of breast cancer in HRT users has been confirmed.”
“Results indicate a small increased risk of ovarian cancer in hysterectomised women with long-term use of oestrogen-only HRT.”
The research evidence is based on a large cohort study, which suffers from a small number of potentially significant flaws which may have an impact on the study findings and limit its relevance to women currently taking HRT in countries outside the USA.
Both duration of use and the recency of therapy had an effect on the risk of dying from ovarian cancer.
The randomised world is not without its imperfections: reflections on the Women's Health Initiative Study
McDonough PG. Fertil Steril 2002 Nov;78(5):951-6
The WHI trial presents a challenge for patients, physicians, and epidemiologists, since many observational studies have shown cardiovascular benefits of long-term HRT.
symptoms of the menopause is not being contested.
long-term effects of HRT
Beral V, Banks E, Reeves G. Lancet 2002 Sep 21;360(9337):942-4
Overall, HRT users had a significantly increased incidence of:
a significantly reduced incidence of:
but no significant change in: