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Effect of hormone replacement therapy
on cardiovascular events in recently postmenopausal women: randomised trial

BMJ 2012; 345 (Published 9 October 2012) [Lire]
Louise Lind Schierbeck, registrar1, Lars Rejnmark, associate professor, consultant2, Charlotte Landbo Tofteng, staff specialist 11, Lis Stilgren, consultant3, Pia Eiken, consultant, senior endocrinologist4, Leif Mosekilde, professor, senior consultant2, Lars Køber, professor, consultant5, Jens-Erik Beck Jensen, associate professor, consultant1

Le traitement hormonal de la ménopause réhabilité ?
Ce travail a duré dix ans et les femmes ont été suivies six années de plus. Les résultats sont éloquents : au début de l'étude, il y a eu moitié moins de décès et d'hospitalisations pour insuffisance cardiaque ou infarctus dans le groupe recevant le THS que dans l'autre. De plus, le taux de mortalité était réduit de 43 % sous THS (mais les auteurs estiment que ce chiffre n'est pas significatif), tandis que celui d'insuffisance cardiaque était significativement diminué de 86 % dans le groupe THS. Après 16 ans de suivi, la fréquence des décès et des hospitalisations pour problème cardiaque était réduite de 40 % dans le groupe sous THS. De plus, les spécialistes n'ont pas noté chez ces femmes de risque accru de cancer, de thrombo-embolie veineuse ou d'accident vasculaire cérébral.

Objective
To investigate the long term effect of hormone replacement therapy on cardiovascular outcomes in recently postmenopausal women.

Design
Open label, randomised controlled trial.

Participants
1006 healthy women aged 45-58 who were recently postmenopausal or had perimenopausal symptoms in combination with recorded postmenopausal serum follicle stimulating hormone values. 502 women were randomly allocated to receive hormone replacement therapy and 504 to receive no treatment (control). Women who had undergone hysterectomy were included if they were aged 45-52 and had recorded values for postmenopausal serum follicle stimulating hormone.

Interventions
In the treatment group, women with an intact uterus were treated with triphasic estradiol and norethisterone acetate and women who had undergone hysterectomy received 2 mg estradiol a day. Intervention was stopped after about 11 years owing to adverse reports from other trials, but participants were followed for death, cardiovascular disease, and cancer for up to 16 years. Sensitivity analyses were carried out on women who took more than 80% of the prescribed treatment for five years.

Main outcome measure
The primary endpoint was a composite of death, admission to hospital for heart failure, and myocardial infarction.

Results
At inclusion the women on average were aged 50 and had been postmenopausal for seven months. After 10 years of intervention, 16 women in the treatment group experienced the primary composite endpoint compared with 33 in the control group (hazard ratio 0.48, 95% confidence interval 0.26 to 0.87; P=0.015) and 15 died compared with 26 (0.57, 0.30 to 1.08; P=0.084). The reduction in cardiovascular events was not associated with an increase in any cancer (36 in treated group v 39 in control group, 0.92, 0.58 to 1.45; P=0.71) or in breast cancer (10 in treated group v 17 in control group, 0.58, 0.27 to 1.27; P=0.17). The hazard ratio for deep vein thrombosis (2 in treated group v 1 in control group) was 2.01 (0.18 to 22.16) and for stroke (11 in treated group v 14 in control group) was 0.77 (0.35 to 1.70). After 16 years the reduction in the primary composite outcome was still present and not associated with an increase in any cancer.

Conclusions
After 10 years of randomised treatment, women receiving hormone replacement therapy early after menopause had a significantly reduced risk of mortality, heart failure, or myocardial infarction, without any apparent increase in risk of cancer, venous thromboembolism, or stroke.

Trial registration ClinicalTrials.gov NCT00252408.
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