Hormones and Cardiovascular Disease
Director: Pierre-Yves Scarabin

Hormones and Cardiovascular Disease
Director: Pierre-Yves Scarabin

Hormones and Cardiovascular Disease
Director: Pierre-Yves Scarabin

 

Why the PRESSTO study ?

 

Despite a striking decrease in postmenopausal hormone therapy (HT) use, many women remain prescribed this treatment for its efficiency to correct menopausal symptoms. Recent guidelines recommend that women be prescribed the lowest effective dose of HT for the shortest possible duration. In this context, both pulmonary embolism and stroke are the main harmful effects of HT Thus, reducing the vascular risks attributable to HT could improve its benefit/risk ratio. It has been shown that oral estrogens, but not transdermal estrogens  combined with micronised progesterone, increased the risk of venous thromboembolism. In addition, an observational study has recently suggested that transdermal estrogens might be safe with respect to stroke risk. However, data on the stroke risk among trandermal estrogens users remain scarce. In addition, the impact of the different progestogens on stroke risk has not been investigated yet.

 

 

Objectives of th PRESSTO study

 

The PRESSTO study (PRogestogens, EStrogens and STroke) aims to investigate the impact of transdermal estrogens and different pharmacological classes of progestogens on stroke risk among postmenopausal women.

 

 

Study design

 

The PRESSTO study is a case/control study nested in a cohort of French women who participate in the national health care insurance database (Système national d'Information Inter Régimes de l'Assurance Maladie (SNIIRAM). This database covering the 97 % of the French population includes information on reimbursed prescription medicines and is linked by patient to the French national hospital database (Programme de Médicalisation des Systèmes d'Information [PMSI]). Study population consists of women aged 51 to 70 years with no personal history of cancer or cardiovascular disease neither anticoagulant therapy. Stroke cases have to be hospitalized and be identified by PMSI data. Controls are healthy women selected at random from the full cohort and matched to the  cases by age and area of residence (4 controls by case). Using conditional logistic regressions, we will assess the stroke risk for each estroprogestinic combination compared to non-use and we will make inter-treatment comparisons. Assuming that 10 % of women use HT (one third by oral estrogen route and two thirds by transdermal estrogen route) and a distribution of progestogens similar as the one observed in previous studies on French data, we need approximately 20 000 cases and 80 000 controls to detect an odds ratio of stroke of 1.5 between each estroprogestinic combination with an 80% power at 5 % significance level.

 

 

Expected Results

 

These results should provide relevant data regarding the safety of transdermal estrogens as well as the impact of the progestogens on the stroke risk. Reducing the risks attributable to HT could substantially improve the benefit/risk ratio of this treatment, especially for short-term HT use. Considering the number of postmenopausal women using HT and the excess incidence of stroke and pulmonary embolism attributable to Ht use, around 2 000 cases of these adverse events could be avoided for one year in France.

© Esther 2019