topeeng.gif (8416 bytes)

[ Scientific Activity - Actividad Científica ] [ Brief Communications - Temas Libres ]

Feasibility study of substitution hormonal therapy on cardiovascular diseases in post-menopausal women. A multicentric international collaboration (part I).

Ioan Axente Gutiu; Ligia Dolis; Dan Peretianu.

Spitalul Clinic "Sfanta Maria"
Bvd Ion Mihalache 37-39; sector 1
Bucharest, Romania
in collaboration with MRC Wolfson Institute-London, UK.

Abstract
Introduction
Objectives
Methods
Results
Conclusions

Abstract
Introduction:
This is a multicentric international study which propose to follow the substitution hormonal therapy (SHT) on cardiovascular diseases in post-menopausal women (PMW).
Objectives: Feasibility study of SHT on Romanian PMW (from Bucharest), based on English working protocol of the coordinator and on the good practice rules. We proposed to include in trial 100-150 PM women. We solicited 450 women for study participation, age between 50-64 years, which have lesser 1 year after the stop of menstruation and which accepted all conditions to include in study (absence of mammary, uterine or other cancers, deep venous phlebitis etc). All conditions was accepted by 150 women, but effectively was registered only 120 women. Mean age was 55+/-5 years.
Methods: All PMW was randomized in many groups of study. Was administrated either active SHT (estrogens as Progynova or estrogens and progesterone as Climen, both from Schering) or Placebo (Pl) in women grouped: 1. nonhysterectomized (84) randomized for Climen (42) or Pl (42) and hysterctomized (36) randomized for Climen (12), Progynova (12), Pl (12). The effectuated investigations was: clinical history; laboratory data for blood lipids, coagulation, inflammation, cytovaginal control; mammography; osteodensitometry DEXA. Cardiology investigations was: ECG, exercise ECG, echocardiography and Holter registrations, in selected case. Control examinations was made at 3 months mean period, excepting mammogarphy and DEXA.
Results: After 3 months 50 PMW (41%) retired from the study for: altered first mammography 18 (15%), for side drug reactions (only for Progynova) 8(6%), for other reasons 24 (20%).
Conclusions: This feasibility study show that, in Romania, a clinical trial on cardiovascular and general effects of SHT in PMW is possible. But, for realization of the proposed aim of the study to followi a minimum 600 women in 10 year, we estimate the need of recruitment of approximately 1000 women, which conform to protocol conditions.

Top

Introduction
This is our collaboration in a multicentric international study begun in England at MRC Wolfson Institute from London coordinated by Prof. TW Meade and Dr Madge Vickers (acronym of study is WISDOM).
This clinical trial propose to follow-up the effects of the substitution hormonal therapy (SHT) on cardiovascular diseases in post-menopausal women for a 10 years follow-up period.
In Romania this is the first study in the field of PM women cardiovascular diseases.

Objectives
Our target was to test the possibility to make a follow-up study of the substitution hormonal therapy in a Romanian post-menopausal women and the effects of this therapy on the incidence and the evolution of the cardiovascular diseases in this population.
The feasibility study of SHT on Romanian post-menopausal women (from Bucharest), based on English MRC working protocol of the coordinator and on the good practice rules.
We proposed to include in trial 100-150 post-menopausal women. We solicited 450 women for study participation, age between 50-64 years, which have lesser 1 year after the stop of menstruation and which accepted all conditions to include in study (absence of mammary, uterine or other cancers, deep venous phlebitis etc). All conditions was accepted by 120 women. Mean age was 55+/-5 years.

Table 1. Recruitment of the post-menopausal women

 

Methods
All post-menopausal women was randomized in many groups of study following the MRC protocol. We administrated either active SHT (estrogens as Progynova or estrogens and progesterone as Climen, both from Schering) or Placebo (Pl) in women grouped: nonhysterectomized (84) randomized for Climen (42) or Pl (42) and hysterctomized (36) randomized for Climen (12), Progynova (12), Pl (12).

The effectuated investigations was: clinical history; laboratory data for blood lipids, coagulation, inflammation (fibrinogen, C-reactive protein), cytovaginal control, mammography; osteodensitometry DEXA (only in 10% of subjects). Cardiology investigations was: ECG, exercise ECG, echocardiography and Holter registrations (in selected cases). Control examinations was made at 3 months mean period, excepting mammography and DEXA.

Results
The results are presented in Table 2.
After 3 months 50 post-menopausal women (41%) retired from the study for: altered first mammography 18 (15%), for side drug reactions (only for Progynova) 8(6%), for other reasons 24 (20%).

Table 2. The group of the post-menopausal women in feasibility study

Abbreviations: U+ or U- (with or without uterus);
PORT (Progesteron and Oestrogen Therapy);
ORT (Oestrogen Therapy); PL (Placebo)

After 6 months remained in the study only 56 women (47%). The reasons of the exclusions was the same with the reasons at 3 months following interval.
These all reasons are presented in the Table 3.

Table 3. The reasons for exclusions

Conclusions
This feasibility study show that, in Romania, a clinical trial on cardiovascular and general effects of SHT in post-menopausal women is possible. But, for realization of the proposed aim of the study to follow-up a minimum 600 women in 10 year, we estimate the need of recruitment of approximately 1500 women or more, which conform to protocol conditions.

 

Questions, contributions and commentaries to the Authors: send an e-mail message (up to 15 lines, without attachments) to epi-pcvc@pcvc.sminter.com.ar , written either in English, Spanish, or Portuguese.

Top


© CETIFAC
Bioengineering
UNER

Update
Nov/02/1999


This company contributed to the Congress:

klchlogo4.gif (6328 bytes)