Intranasal continuous combined 17 beta-estradiol/norethisterone therapy improves the lipid profile in healthy postmenopausal women.
OBJECTIVE
To compare the effects of continuous combined 17beta-estradiol (E2) plus norethisterone (acetate) [NET(A)] therapy by either intranasal or oral administration on the lipid profile in postmenopausal women.


METHODS
Randomized, double-blind, multicenter trial.


METHODS
Gynecologic outpatient department.


METHODS
Two-hundred thirty-three healthy postmenopausal women.


METHODS
Women received continuous combined hormone therapy, either intranasal E2/NET (175 microg/275 microg) as a spray (n = 117) or oral E2/NETA (1 mg/0.5 mg) as a capsule (n = 116), for 1 year.


METHODS
Fasting plasma concentrations of lipids and (apo)lipoproteins; and atherogenic indices at baseline and after 12, 24, and 52 weeks of treatment.


RESULTS
We found a significant (P < .001) decrease from baseline in both treatment groups in total, low-density lipoprotein- (LDL), high-density lipoprotein- (HDL), and HDL2-cholesterol, in triglycerides, apolipoprotein B (apoB), and lipoprotein(a). Levels of HDL3-cholesterol and apolipoprotein A1 (apoA1) were transiently decreased in the intranasal group. In the oral group, compared with the intranasal group, the decrease was larger for ratio total and LDL-cholesterol and lipoprotein(a) and smaller for triglycerides and apoA1. In the oral group, the ratios total/HDL cholesterol and LDL/HDL cholesterol were lowered, and the ratio apoB/LDL was increased, more than in the intranasal group.


CONCLUSIONS
Both intranasal and oral E2/NET(A) therapy improved the lipid profile of healthy postmenopausal women, with some effects being more pronounced after oral administration.
Department of Obstetrics and Gynecology, Project Aging Women, Institute for Cardiovascular Research, VU University Medical Center, Amsterdam, The Netherlands. mj.vandermooren@vumc.nl
Majoie
M
Hemelaar
Peter
P
Kenemans
Lut
L
de Bie
Peter H M
PH
van de Weijer
Marius J
MJ
van der Mooren
D000281:Administration, Intranasal; D000284:Administration, Oral; D000336:Aerosols; D002784:Cholesterol / Q000097:blood; D004311:Double-Blind Method; D004338:Drug Combinations; D004958:Estradiol / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D038622:Internationality; D008055:Lipids / Q000097:blood*; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage*; D017698:Postmenopause / Q000097:blood* / Q000187:drug effects*; D013997:Time Factors
D000336:Aerosols; D004338:Drug Combinations; D008055:Lipids; D004958:Estradiol; D002784:Cholesterol; D009640:Norethindrone