TY - JOUR
T1 - A novel intermittent regimen of norgestimate to preserve the beneficial effects of 17β-estradiol on lipid and lipoprotein profiles
AU - Lobo, R. A.
AU - Zacur, H. Z.
AU - Caubel, P.
AU - Lane, R.
N1 - Funding Information:
Principal investigators and their institutional affiliations were as follows: Kenneth Burry, MD, Oregon Health Sciences University, Portland, Ore; Bruce R. Carr, MD, University of Texas Southwestern Medical Center, Dallas; George E. Dailey, MD, Scripps Clinic & Research Foundation, La Jolla, Calif; Edward C. Ditkoff, MD, Columbia Presbyterian Medical Center, New York; Charles L. Goldsmith, MD, South Florida Bioavailability Clinic, Miami; M. Wayne Heine, MD, University of Arizona, Arizona Health Sciences Center, Tucson; Andrew M. Kaunitz, MD, University of Florida Health Science Center–Jacksonville, Jacksonville, Fla; Anthony A. Luciano, MD, New Britain General Hospital, New Britain, Conn; Ken Muse, MD, University of Kentucky, Department of Obstetrics and Gynecology, Lexington; Morris Notelovitz, MD, Women’s Medical & Diagnostic Center, Gainesville, Fla; John Nulsen, MD, John Dempsey Hospital, University of Connecticut Health Center, Farmington, Conn; Sherwyn L. Schwartz, MD, Diabetes & Glandular Disease Clinic, PA, San Antonio, Texas; Marquerite K. Shepard, MD, Indiana University Medical Center, Indianapolis; Ian H. Thorneycroft, PhD, MD, University of South Alabama Obstetrics and Gynecology, Mobile; Brian W. Walsh, MD, Brigham & Women’s Ambulatory Care Center, Chestnut Hill, Mass; Mary Yankakas, MD, Clinical Physiology Associates, Clinical Study Center, Fort Myers, Fla; and Michael J. Zinaman, MD, Loyola University Medical Center, Department of Obstetrics and Gynecology, Maywood, Ill.
PY - 2000
Y1 - 2000
N2 - OBJECTIVE: This study was undertaken to evaluate the effects of 3 dosage levels of intermittent norgestimate plus a constant dose of 17β-estradiol on blood lipid and lipoprotein concentrations in 236 postmenopausal women. STUDY DESIGN: 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 μg, 90 μag, or 180 μag norgestimate for 360 days. RESULTS: The regimens of 1 mg estradiol plus 30 μg norgestimate and 1 mg estradiol plus 90 μg norgestimate increased concentrations of high-density lipoprotein cholesterol, HDL2 high-density lipoprotein cholesterol, HDL3 high-density lipoprotein cholesterol (except the regimen of 1 mg estradiol plus 30 μg 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 μg norgestimate reduced concentrations of high-density lipoprotein cholesterol, high-density lipoprotein HDL3 cholesterol, and apolipoprorein 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 μg 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 17β-estradiol daily; however, 180 μg norgestimate did not do so.
AB - OBJECTIVE: This study was undertaken to evaluate the effects of 3 dosage levels of intermittent norgestimate plus a constant dose of 17β-estradiol on blood lipid and lipoprotein concentrations in 236 postmenopausal women. STUDY DESIGN: 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 μg, 90 μag, or 180 μag norgestimate for 360 days. RESULTS: The regimens of 1 mg estradiol plus 30 μg norgestimate and 1 mg estradiol plus 90 μg norgestimate increased concentrations of high-density lipoprotein cholesterol, HDL2 high-density lipoprotein cholesterol, HDL3 high-density lipoprotein cholesterol (except the regimen of 1 mg estradiol plus 30 μg 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 μg norgestimate reduced concentrations of high-density lipoprotein cholesterol, high-density lipoprotein HDL3 cholesterol, and apolipoprorein 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 μg 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 17β-estradiol daily; however, 180 μg norgestimate did not do so.
KW - 17β-Estradiol
KW - Hormone replacement therapy
KW - Lipids
KW - Lipoproteins
KW - Norgestimate
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U2 - 10.1016/S0002-9378(00)70489-3
DO - 10.1016/S0002-9378(00)70489-3
M3 - Article
C2 - 10649155
AN - SCOPUS:0033977845
SN - 0002-9378
VL - 182
SP - 41
EP - 49
JO - American journal of obstetrics and gynecology
JF - American journal of obstetrics and gynecology
IS - 1 I
ER -