Angeliq versus Activelle in normotensive postmenopausal women: a prospective, randomized pilot study.
OBJECTIVE
The aim of this study was to compare, in normotensive postmenopausal women, the effects of drospirenone/estradiol and norethisterone acetate/estradiol on blood pressure and other surrogate markers of cerebrovascular and cardiovascular risk.


METHODS
Thirty postmenopausal women were submitted to utero-ovarian ultrasonography and to color Doppler evaluation of ophthalmic arteries. Ultrasonographic and Doppler analysis of brachial artery flow-mediated vasodilatation and 24-hour ambulatory blood pressure monitoring were performed. Plasma concentrations of nitrites/nitrates were assayed. The participants were randomly assigned to drospirenone 2 mg/estradiol 1 mg (group 1; n = 15) or norethisterone acetate 0.5 mg/estradiol 1 mg (group 2; n = 15) treatment. The duration of the study was 6 months.


RESULTS
The basal pulsatility index and the back pressure of the ophthalmic artery were similar in groups 1 and 2. After 6 months, no changes were observed. The nitrites/nitrates values were not different between groups 1 and 2 both in basal conditions and after therapy. The brachial artery flow-mediated vasodilatation and the pulsatility index of the brachial artery did not show any difference in groups 1 and 2 both in basal conditions and after the therapy. The 24-hour blood pressure monitoring showed no significant differences in the 24-hour time, daytime, and nighttime values either in basal conditions or after therapy. All participants were found to be dippers normally (nocturnal reduction > or =10% in comparison with diurnal values). The wake-up blood pressure values were similar in the studied participants.


CONCLUSIONS
A 6-month hormone therapy with drospirenone/estradiol or norethisterone acetate/estradiol is equally effective and does not seem to alter the surrogate markers of cardiovascular and cerebrovascular risk.
Battaglia
Cesare
C
Department of Obstetrics and Gynecology, Alma Mater Studiorum, University of Bologna, Bologna, Italy. cesare.battaglia@unibo.it
Cianciosi
Arianna
A
Mancini
Fulvia
F
Persico
Nicola
N
Sisti
Giovanni
G
Facchinetti
Fabio
F
Busacchi
Paolo
P
D000736:Androstenes / Q000008:administration & dosage / Q000009:adverse effects*; D001794:Blood Pressure / Q000187:drug effects; D001916:Brachial Artery / Q000000981:diagnostic imaging; D002318:Cardiovascular Diseases / Q000139:chemically induced; D002319:Cardiovascular System / Q000187:drug effects*; D002560:Cerebrovascular Circulation / Q000187:drug effects; D002561:Cerebrovascular Disorders / Q000139:chemically induced; D004338:Drug Combinations; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077563:Norethindrone Acetate; D009880:Ophthalmic Artery / Q000187:drug effects / Q000502:physiology; D010053:Ovary / Q000000981:diagnostic imaging; D010865:Pilot Projects; D017698:Postmenopause; D011446:Prospective Studies; D011673:Pulsatile Flow / Q000187:drug effects; D012307:Risk Factors; D014463:Ultrasonography; D014599:Uterus / Q000000981:diagnostic imaging; D014664:Vasodilation
D000736:Androstenes; D004338:Drug Combinations; C488382:estradiol-drospirenone combination; D004958:Estradiol; D000077563:Norethindrone Acetate; D009640:Norethindrone