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document
Cardiovascular risk markers during treatment with estradiol and trimegestone or dydrogesterone . OBJECTIVE To study cardiovascular risk markers in women taking estradiol/trimegestone or estradiol/dydrogesterone . DESIGN Multicenter , randomized , prospective , double-blind study of 184 healthy post-menopausal women randomized to 6 cycles of either estradiol ( 2mg ) +trimegestone ( 0.5mg ) ( T-group ) or estradiol ( 2mg ) +dydrogesterone ( 10mg ) ( DYDR group ) . Cardiovascular risk markers were measured before , after cycle 1 , 3 and 6 and at 4 weeks post-treatment . RESULTS Fibrinogen was reduced in both groups but more markedly in the DYDR group . Factor VIIc activity levels decreased in both groups with a greater change in the T-group . Factor VII antigen was increased in both groups with a greater increase in the DYDR group . Factor VIIa was increased in the DYDR group only . Plasminogen levels were also increased in both groups with a greater increase in the T-group . There were no statistically significant changes in lipid variables between the different regimens . Changes in total cholesterol and LDL cholesterol were correlated positively with changes in factor VIIc in the DYDR group and negatively with changes in factor VIIc in the T-group . Trigemestone was associated with a better bleeding pattern . CONCLUSIONS Trimegestone was associated with less procoagulant changes in factor VIIa and factor VIIc activity and larger decrease in PAI-1 activity compared with the dydrogesterone preparation . These results reflect less androgenic properties of the trimegestone preparation . The fibrinogen level and Lp ( a ) were more decreased during dydrogesterone treatment . Further investigation is required to clarify the relative importance of beneficial effects with respect to cardiovascular risk .
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Intervention_Pharmacological
estradiol
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Intervention_Pharmacological
trimegestone
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Intervention_Pharmacological
dydrogesterone
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Intervention_Pharmacological
6 cycles of either estradiol ( 2mg ) +trimegestone ( 0.5mg ) ( T-group )
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Intervention_Pharmacological
estradiol ( 2mg ) +dydrogesterone ( 10mg ) ( DYDR group )
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Intervention_Physical
Cardiovascular risk markers
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Outcome_Other
Cardiovascular risk markers
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Outcome_Physical
cardiovascular risk markers
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Outcome_Other
Cardiovascular risk markers
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Outcome_Other
Factor VII antigen
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Outcome_Other
lipid variables
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Outcome_Physical
total cholesterol and LDL cholesterol
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Outcome_Physical
factor VIIc
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Outcome_Other
factor VIIc
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Participant_Sex
women
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Participant_Condition
taking estradiol/trimegestone or estradiol/dydrogesterone
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Participant_Sample-size
184
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Participant_Condition
healthy post-menopausal
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Participant_Sex
women