title: Effect of hormone replacement therapy with the anti-mineralocorticoid progestin Drospirenone compared to tibolone on endothelial function and central haemodynamics in post-menopausal women.
abstract: Drospirenone (DRSP) is an antialdosterone agent with progestogenic and antiandrogenic effects. This compound, has been recently used in combination with 17β-estradiol (E2) as hormonal therapy in postmenopausal women and has been shown to exert a significant antihypertensive effect in hypertensive post-menopausal women. Aim of the present study was to compare the effect of DRSP/E2 with those of Tibolone (T) on endothelial function, arterial stiffness, and lipid profile of early postmenopausal women naïve on post-menopausal hormonal therapy. Twenty-four women met the inclusion criteria and entered the study. Women were randomized to receive either DRSP/E2 or T for 6months. Blood pressure and heart rate were similar in both groups at baseline and at the end of the study. Compared to baseline, endothelial function assessed by Reactive Hyperemia (RH) significantly improved in women receiving E2/DRSP, whereas no significant differences between baseline and follow up were detected in women receiving Tibolone. Women receiving E2/DRSP showed a significant decrease in pulse wave velocity and Augmentation Index compared to baseline while no changes were observed in women receiving Tibolone. The capacity of sera to trigger endothelial cells apoptosis in vitro measured by cell death assay was significantly reduced by E/DRSP but not by T (HFA-E 70±5,6% vs HFD-E 41±4,5%, p<0,001). In conclusion, the present study shows that the association of Estradiol and Drospirenone as hormonal replacement therapy significantly improves vascular parameters and the composition of sera relevant for vascular protection in early post-menopausal normotensive women. These effects are not shared by Tibolone.
authors.affiliation: Department of Medical Sciences, IRCCS San Raffaele, Roma, Italy. Electronic address: cristiana.vitale@sanraffaele.it.
authors.forename: Cristiana
authors.initials: C
authors.lastname: Vitale
authors.affiliation: Department of Medical Sciences, IRCCS San Raffaele, Roma, Italy.
authors.forename: Caterina
authors.initials: C
authors.lastname: Mammi
authors.affiliation: Department of Obstetrics and Gynecology, University of Pisa, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Gambacciani
authors.affiliation: Department of Medical Sciences, IRCCS San Raffaele, Roma, Italy.
authors.forename: Novella
authors.initials: N
authors.lastname: Russo
authors.affiliation: Department of Medical Sciences, IRCCS San Raffaele, Roma, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Spoletini
authors.affiliation: Department of Medical Sciences, IRCCS San Raffaele, Roma, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Fini
authors.affiliation: Department of Medical Sciences, IRCCS San Raffaele, Roma, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Volterrani
authors.affiliation: Department of Medical Sciences, IRCCS San Raffaele, Roma, Italy; Cardiovascular & Cell Sciences Institute, St Georges Hospital Medical School, London, UK.
authors.forename: Giuseppe M C
authors.initials: GMC
authors.lastname: Rosano
mesh_terms: D000736:Androstenes / Q000627:therapeutic use*; D001795:Blood Pressure Determination; D002318:Cardiovascular Diseases / Q000517:prevention & control; D002478:Cells, Cultured; D004311:Double-Blind Method; D004338:Drug Combinations; D042783:Endothelial Cells / Q000187:drug effects / Q000502:physiology; D004730:Endothelium, Vascular / Q000187:drug effects* / Q000502:physiology; D004958:Estradiol / Q000627:therapeutic use; D005260:Female; D006439:Hemodynamics / Q000187:drug effects*; D020249:Hormone Replacement Therapy / Q000379:methods; D006801:Humans; D006973:Hypertension / Q000517:prevention & control; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000627:therapeutic use*; D009652:Norpregnenes / Q000627:therapeutic use*; D017698:Postmenopause / Q000187:drug effects* / Q000502:physiology; D011372:Progestins / Q000627:therapeutic use; D063177:Pulse Wave Analysis; D012016:Reference Values; D016896:Treatment Outcome
chemical_list: D000736:Androstenes; D004338:Drug Combinations; D000451:Mineralocorticoid Receptor Antagonists; D009652:Norpregnenes; D011372:Progestins; D004958:Estradiol; C027385:tibolone; C035144:drospirenone
keywords: Augmentation index; Drospirenone; Endothelial function; Hormone replacement therapy; Prognosis; Pulse wave velocity