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.
Hemelaar
Majoie
M
Department of Obstetrics and Gynecology, Project Aging Women, Institute for Cardiovascular Research, VU University Medical Center, Amsterdam, The Netherlands. mj.vandermooren@vumc.nl
Kenemans
Peter
P
de Bie
Lut
L
van de Weijer
Peter H M
PH
van der Mooren
Marius J
MJ
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