A novel intermittent regimen of norgestimate to preserve the beneficial effects of 17beta-estradiol on lipid and lipoprotein profiles.
OBJECTIVE
This study was undertaken to evaluate the effects of 3 dosage levels of intermittent norgestimate plus a constant dose of 17beta-estradiol on blood lipid and lipoprotein concentrations in 236 postmenopausal women.


METHODS
In this multicenter, double-blind, parallel-group trial the subjects were randomly assigned to receive 1 mg estradiol daily or 1 mg estradiol daily plus intermittent (3 days off and 3 days on) doses of 30 microg, 90 microg, or 180 microg norgestimate for 360 days.


RESULTS
The regimens of 1 mg estradiol plus 30 microg norgestimate and 1 mg estradiol plus 90 microg norgestimate increased concentrations of high-density lipoprotein cholesterol, HDL(2) high-density lipoprotein cholesterol, HDL(3) high-density lipoprotein cholesterol (except the regimen of 1 mg estradiol plus 30 microg norgestimate at 7 months), and apolipoprotein apo A-I. They decreased total cholesterol concentration, low-density lipoprotein cholesterol concentration, low-density lipoprotein/high-density lipoprotein ratio, apolipoprotein apo B concentration, and Lp(a) lipoprotein concentration, and they attenuated estradiol-induced increases in triglyceride concentrations. In contrast, the regimen of 1 mg estradiol plus 180 microg norgestimate reduced concentrations of high-density lipoprotein cholesterol, high-density lipoprotein HDL(3) cholesterol, and apolipoprotein apo A-I at 7 months and increased the low-density lipoprotein/high-density lipoprotein ratio at 7 months.


CONCLUSIONS
An intermittent regimen of norgestimate at 30 or 90 microg daily administered for 3 days off followed by 3 days on preserved the beneficial lipid and lipoprotein changes induced by continuous therapy with 1 mg 17beta-estradiol daily; however, 180 microg norgestimate did not do so.
Lobo
R A
RA
Columbia Presbyterian Medical Center, New York, NY 10032, USA.
Zacur
H Z
HZ
Caubel
P
P
Lane
R
R
D000328:Adult; D000368:Aged; D016632:Apolipoprotein A-I / Q000378:metabolism; D001055:Apolipoproteins B / Q000097:blood; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D004311:Double-Blind Method; D004958:Estradiol / Q000008:administration & dosage* / Q000627:therapeutic use; D015914:Estrogen Replacement Therapy; D005260:Female; D006801:Humans; D008055:Lipids / Q000097:blood*; D017270:Lipoprotein(a) / Q000097:blood; D008074:Lipoproteins / Q000097:blood*; D008875:Middle Aged; D009644:Norgestrel / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014280:Triglycerides / Q000097:blood
D016632:Apolipoprotein A-I; D001055:Apolipoproteins B; D008076:Cholesterol, HDL; D008055:Lipids; D017270:Lipoprotein(a); D008074:Lipoproteins; D014280:Triglycerides; D009644:Norgestrel; D004958:Estradiol; D002784:Cholesterol; C017576:norgestimate