Feasibility study of substitution hormonal therapy on cardiovascular diseases in post-menopausal women (part II)

In a finished feasibility study concerning the effects of substitution hormonal therapy (SHT) on the cardiovascular status in the post-menopausal women (pmw) we analysed the rate of participation of the Romanian women, the reasons for abandon to participation, etc. in a multicentric international study.

This study had intention to analyse the cardiovascular status of the pmw proposed for STH.

Only 121 women, who accepted all conditions for participation to study, were included. Mean age was 55 +/- 5 years (45-64 years), 93 women were in natural, and 28 in surgical menopause. The study protocol included analysis of: 1) the coronary risk factors (arterial hypertension, diabetes, smoking, serum lipids level, etc.), 2) inflammatory syndrome (serum fibrinogen, C reactive protein), 3) cardiovascular status (clinical data, ECG).

1) Incidence of essential hypertension was 23%; type II diabetes 17%; smoking 15%; serum high cholesterol was presented in 82%; high lipids level in 56%; high serum triglycerides in 35%; HDL was reduced in 56%. 2) Serum high fibrinogen was detected in 20% and CPR presence in 20%; 3) ECG was altered in 30% (HVS, ST-T modifications). Only 20% from pmw with alterations of ECG have not presented coronary risk factors or inflammatory syndrome.

It is a feasibility study in a domain very extended actually by many multicentric clinical trials. The problem of the effects of SHT on cardiovascular system is still in dispute, and our study estimates the preliminary data at the beginning of a trial. These data show a high percent of pmw, which have already alterations of ECG and a concurrency of coronary risk factors and inflammatory indices. The effects of SHT in these women necessitate still a study on long time interval. For Romanian pmw, these data indicate the importance of the precocious investigations and detection of all coronary risk factors concerning the correct indications of SHT and its effects.