This Article Full Text Full Text (PDF) Submit a related Letter to the Editor Purchase Article View Shopping Cart Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Copyright Permission Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Plotkin, D. Articles by Santoro, N. Search for Related Content PubMed PubMed Citation Articles by Plotkin, D. Articles by Santoro, N.

Lowering Low Density Lipoprotein Cholesterol with Simvastatin, a Hydroxy-3-Methylglutaryl-Coenzyme A Reductase Inhibitor, Does Not Affect Luteal Function in Premenopausal Women

Merck Research Laboratories (D.P., Y.M., J.W., M.L., D.S.), Rahway, New Jersey 07065-0900; Clinical Research Center (S.M.), San Antonio, Texas 78229; Department of Obstetrics and Gynecology, University of Louisville (S.N.), Louisville, Kentucky 40292; Department of Obstetrics and Gynecology, Fallon Clinic (E.P.), Worcester, Massachusetts 01605; Department of Obstetrics and Gynecology, University of Massachusetts Memorial Health Care (E.P.), Worcester, Massachusetts 01605; Department of Obstetrics and Gynecology, Baystate Medical Center (R.B.), Springfield, Massachusetts 01106; Department of Gynecology and Obstetrics, Henry Ford Hospital (D.R.), Detroit, Michigan 48202; and Department of Obstetrics and Gynecology, University of Medicine and Dentistry of New Jersey (N.S.), Newark, New Jersey 07103-2757

Address all correspondence and requests for reprints to: Dr. Diane Plotkin, Department of Clinical Research, Endocrinology and Metabolism, 126 East Lincoln Avenue, P.O. Box 2000, RY34-A236, Rahway, New Jersey 07065-0900. E-mail: . diane_plotkin{at}merck.com

Abstract

In this double-blind, randomized, placebo-controlled study, normally cycling women (n = 86) with elevated low density lipoprotein cholesterol (LDL-C) levels were studied over six menstrual cycles. At the end of the screening phase, participants received placebo for the second menstrual cycle and subsequently were randomized to receive either placebo or simvastatin (40 mg/d) for the next four cycles. The second and sixth menstrual cycles were considered baseline and treatment cycles, respectively. Participants kept a menstrual diary throughout the study and provided daily first-void urine samples during cycles 2 and 6. Urine samples were assayed for LH and pregnanediol glucuronide (PdG). The primary end point was change in luteal phase duration as defined by the day of the urinary LH peak to the day preceding the onset of menstruation. Treatment with simvastatin (40 mg/d) effectively lowered LDL-C by 34.3% (P < 0.001). Simvastatin was generally well tolerated, and no meaningful difference in adverse event profile was observed between treatment groups. Compared with the placebo group, simvastatin did not have clinically relevant effects on luteal phase duration, peak PdG concentration, or integrated luteal phase PdG concentration. The results of this study demonstrate that treatment of healthy premenopausal women for approximately 4 months with simvastatin (40 mg/d) lowers LDL-C without adversely affecting reproductive gonadal function. Simvastatin should not be used during pregnancy or by nursing mothers.

This article has been cited by other articles:

				S. B. Clauss, K. W. Holmes, P. Hopkins, E. Stein, M. Cho, A. Tate, A. O. Johnson-Levonas, and P. O. Kwiterovich Efficacy and Safety of Lovastatin Therapy in Adolescent Girls With Heterozygous Familial Hypercholesterolemia Pediatrics, September 1, 2005; 116(3): 682 - 688. [Abstract] [Full Text] [PDF]

				N. Santoro, B. Lasley, D. McConnell, J. Allsworth, S. Crawford, E. B. Gold, J. S. Finkelstein, G. A. Greendale, J. Kelsey, S. Korenman, et al. Body Size and Ethnicity Are Associated with Menstrual Cycle Alterations in Women in the Early Menopausal Transition: The Study of Women's Health across the Nation (SWAN) Daily Hormone Study J. Clin. Endocrinol. Metab., June 1, 2004; 89(6): 2622 - 2631. [Abstract] [Full Text] [PDF]