For non-oral HT , decreases in lipoprotein(a ) , cell adhesion molecules , and factor VII generally were significant , resistance to activated protein C ( APCr ) was slightly increased , and other markers including CRP and homocysteine did not change .
Compared with oral HT , changes in CRP and APCr were smaller , changes in cell adhesion molecules and some fibrinolytic parameters tended to be smaller , whereas changes in other factors including lipoprotein(a ) and homocysteine did not differ .
( S ) Potentially unfavorable changes seen with oral HT on two important markers , CRP and APCr , are substantially smaller with non-oral HT .
Non-oral HT has minor effects on the other cardiovascular risk markers studied .
Therefore , compared with oral HT , non-oral HT appears be safer with respect to atherosclerotic and venous thromboembolic disease risk
OBJECTIVE To review the effects of non-oral administration of postmenopausal hormone therapy ( HT ) on risk markers for atherosclerotic and venous thromboembolic disease .
Non-oral postmenopausal HT appears not to increase venous thromboembolic risk , whereas the effect on coronary heart disease risk is less clear .
Clinical equivalence of intranasal and oral 17beta-estradiol for postmenopausal symptoms.
OBJECTIVE The aim of this study was to demonstrate clinical equivalence between a novel intranasal estradiol formulation and a reference oral drug . STUDY DESIGN In this multinational , double-blind , parallel-group study 659 postmenopausal women with moderate to severe postmenopausal symptoms were r and omly assigned to receive either 300 microg/d intranasal 17beta-estradiol ( S21400 ) or 2 mg/d oral micronized estradiol , plus the appropriate placebo , for 24 weeks . All patients also received 10 mg/d dydrogesterone for 14 days per 28-day cycle . Adjustment of intranasal dosage was permitted from week 14 on . The primary efficacy criterion was the Kupperman index at week 14 , with a predefined limit of equivalence of 4 . RESULTS Kupperman index scores improved similarly in the 2 groups , from 28.4 + /- 6.2 to 10.0 + /- 8.6 ( mean + /- SD ) for S21400 and from 28.1 + /- 6.0 to 8.9 + /- 8.0 for oral therapy , with a difference between groups at week 14 of 1.1 + /- 0.6 ( 90 % confidence interval , 0 . 0 to 2.2 ) . This was below the predefined equivalence limit of + 4 for statistical noninferiority ( P < .001 ) . The daily number and intensity of hot flushes decreased similarly in the two treatment groups . Withdrawal bleeding was 20 % less frequent with intranasal therapy ( 90 % confidence interval , 12.5 to 27.6 ) . Severe mastalgia was less frequent in the S21400 group ( 1.0 % ) than in the group with oral therapy ( 5.2 % ; P < .01 ) . Triglyceride and angiotensinogen levels increased significantly with oral therapy but not with S21400 . The same number of patients required dose adaptation in the 2 groups ( approximately 20 % ) . CONCLUSION Intranasal administration of 300 microg/d estradiol was at least as effective as oral administration of 2 mg/d estradiol in alleviating postmenopausal symptoms , with less frequent mastalgia and uterine bleeding and without the metabolic consequences of the first-pass effect
For non-oral HT , decreases in lipoprotein(a ) , cell adhesion molecules , and factor VII generally were significant , resistance to activated protein C ( APCr ) was slightly increased , and other markers including CRP and homocysteine did not change .
Compared with oral HT , changes in CRP and APCr were smaller , changes in cell adhesion molecules and some fibrinolytic parameters tended to be smaller , whereas changes in other factors including lipoprotein(a ) and homocysteine did not differ .
( S ) Potentially unfavorable changes seen with oral HT on two important markers , CRP and APCr , are substantially smaller with non-oral HT .
Non-oral HT has minor effects on the other cardiovascular risk markers studied .
Therefore , compared with oral HT , non-oral HT appears be safer with respect to atherosclerotic and venous thromboembolic disease risk
OBJECTIVE To review the effects of non-oral administration of postmenopausal hormone therapy ( HT ) on risk markers for atherosclerotic and venous thromboembolic disease .
Non-oral postmenopausal HT appears not to increase venous thromboembolic risk , whereas the effect on coronary heart disease risk is less clear .